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News and Events:

Qualification of a packaging line

 

Just like all production equipment, a packaging line must also be qualified. The general process for a qualification is described in chapter 6 Qualification. The following pages contain examples for establishing qualification plans for a blister packaging line and the possible test items. These are only a sample and do not claim to be complete; the content of the qualification plans in particular must be adapted to the individual facility.

"Master qualification plan"

"Design qualification protocol"

"Design qualification report"

"Installation qualification protocol"

"Installation qualification report"

"Operational qualification protocol"

"Operational qualification report"

"Performance qualification protocol"

"Performance qualification report"

13.C.1 Master qualification plan

Company name

Logo

Master qualification plan

Doc.no.

Blister pack line

Page x of y

valid from:                           

compiled

Name/function

Date

Signature

Head of qualification

                                                   

                                                 

checked

Head of project

                                                

                                                

Head of process technology

                                                

                                                

approved

Head of packaging company

                                                

                                                

Head of quality assurance

                                                

                                                

Archiving

Quality assurance (original)                          

Packaging unit (copy)                  

Document version index

Version

Changes

Date

1

New facility

see signature

Contents

"Objectives"

"Responsibilities"

"Archiving"

"Short project description"

"Documents"

"Carrying out the qualification"

"Qualification phases"

"Test plans"

"Documentation of deficiencies"

"Result of the qualification levels"

Objectives

Only machines and facilities that are suitable for the specific purpose and for which this suitability can be demonstrated may be used to manufacture pharmaceutical products. The qualification of the machines and facilities is an adequate means of providing this proof. The various requirements and areas are described below with reference to the general master qualification plan (MQP) (SOP A1000-1). The objective of the qualification plan is to provide a summary of the qualification project.

Responsibilities

The allocated responsibilities for the various activities within the qualification project are listed below.

The personnel in the qualification team may be increased or modified, if necessary, within the qualification phase. If this is the case, the basic roles must still be guaranteed.

Role

Description of tasks

Name

Company

Project manager

  • Responsible for the co-ordination of the entire project

Peter Luchs

GMP-V

Head of qualification

  • Responsible for the co-ordination of the qualification activities
  • Planning measures
  • Managing the tests
  • Documentation checking

Ludwig
Qualle

GMP-V

Documentation representative

  • Compiling qualification documents
  • Documentation of the tests
  • Archiving (Q-Dok)

Dieter Bär

GMP-V

Electrical engineering technician

  • Implementing measures and tests with regard to electrical equipment

Edgar
Tiger

Electrotest

Data
technician

  • Implementing measures and tests with regard to control technology

Detlef Trudel

Data-test

Machine technician

  • Implementing measures and tests with regard to mechanical equipment

Martin Tappsig

GMP-V

Safety
engineer

  • Implementing measures and tests with regard to safety equipment

Siegfried Fuchs

GMP-V

Archiving

Qualification documents are archived in their original form in the packaging area (Q-Dok file) once they have received final authorisation from quality assurance. Copies of the qualification results are archived in the quality assurance, production management and packaging management departments. Quality assurance distributes the documents.

The documents are electronically stored under Q:\2003-01-VP\10003\ via the document management system.

Project planning

The objective is to start up the facility in October 2004. A rough outline is provided for information purposes.

Short project description

There follows a short description of the project.

The detailed description of the requirements can be found in the corresponding documents. An additional packaging line must be installed to increase the capacity of solid, oral dosage forms. The entire modular facility consists of a thermoforming line, cartoning machine and bundling machine.

The machine is primarily for the processing of aluminium cover foil and aluminium thermoforming foil. It must be possible to process other standard foils, e.g. PVC foils. All the processing steps and process data must be able to be visualised during production. Data and fault messages must be documented.

The design must allow separation of the GMP and engineering areas.

It must be possible to observe the production process from outside.

The product feed must be realised in a simple way which protects the product and which is part of the facility equipment.

All surfaces that come into contact with the product must be of adequate quality, e.g. electro-polished stainless steel.

A more precise definition of the requirements is presented in the user requirements and/or required specifications.

Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

User requirements

Q:\2003-01-VP\10003\DQP-LHA03.pdf

Technical specifications

Q:\2003-01-VP\10003\DQP-PH01A02.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

Carrying out the qualification
Qualification phases

The following phases will run throughout the entire qualification process:

  • Design qualification
  • Installation qualification
  • Function qualification
  • Performance qualification

Individual plans are compiled for these phases. The subsequent qualification phases cannot be commenced until the previous phase is complete. Completion is to be formally recognised by the authorisation and release of the report that is to be compiled. Deficiencies are permitted, insofar as they are not relevant to quality.

Plans and reports are compiled in the established format (SOP A1000-1).

Test plans

The test plans relating to the individual qualification levels are compiled and authorised accordingly by the persons responsible. The plans of the qualification levels contain references to the relevant authorised test plans.

Documentation of deficiencies

Deficiencies lists are to be drawn up to document deficiencies in a given qualification phase. The measures for remedying the deficiencies are also established in these lists. The deficiencies are evaluated and the measures are established by the qualification team. If the documented deficiencies are not relevant to quality, they may be passed on to the subsequent qualification phase.

The format for deficiencies lists is described below.

Aspect

Description

Measure

xxx

xxx

xxx

Result of the qualification levels

A result is generated for the qualification activities based on the associated plan for the qualification level.

The level for the relevant qualification is:

x complete.
o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the subsequent qualification level.

The overall result of the qualification includes an evaluation of the performance qualification.

The level of operational qualification is

x complete.
o not complete

A list of deficiencies has been finalised.

The facility is qualified and released for production.

All changes to the facility are subject to the change control procedure (SOP A1000CC05).

13.C.2 Design qualification (DQ)

13.C.2.1 Design qualification protocol

Company name

Logo

Design qualification protocol

Doc.no.

Blister pack line

Page x of y

valid from:                               

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                               

Packaging unit(copy)                                         

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"Objectives"

"Responsibilities"

"Checks"

"Documents"

Objectives

The objective of the design qualification is to define the requirements on the facility to ensure that the facility is suitable for the intended production stage.. The associated specifications must be adapted to the precise facility in each individual case.

The requirements are documented in the user requirements and/or the technical specifications, which are used to draw up a quote.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the design qualification:

Document check regarding presence, completeness and approval:

  • User requirements
  • Technical specifications
  • Order, order confirmation
  • Status of the supplier qualification
  • Component list
  • Installation plan
  • Electro plans, pneumatics plans
  • Project plan

Comparison of:

  • Technical specification/order confirmation

Compilation of a:

  • Risk analysis
  • Deficiencies list (DQ)
Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

User requirements

Q:\2003-01-VP\10003\DQP-LHA03.pdf

Technical specifications

Q:\2003-01-VP\10003\DQP-PH01A02.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

13.C.2.2 Design qualification report

Company name

Logo

Design qualification report

Doc.no.

Blister pack line

Page x of y

valid from:

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                                

Packaging unit (copy)                                 

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"Documentation checking"

"Risk analysis"

"Framework documents"

"Deficiencies list"

"Result of the design qualification"

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document

Testing

File path

User requirements

complies

Q:\2003-01-VP\10003\DQP-LHA03.pdf

Technical specifications

complies

Q:\2003-01-VP\10003\DQP-PH01A02.pdf

Order, order confirmation

complies

Q:\2003-01-VP\10003\DQB-AUF04A03.pdf

Q:\2003-01-VP\10003\DQB-AB01A01.pdf

Status of the supplier qualification

complies

Q:\SuppQual\VP05.pdf

Component list

complies
see list of deficiencies

Q:\2003-01-VP\10003\DQB-FL01A01.pdf

Installation plan

complies

Q:\2003-01-VP\10003\DQB-AUFPL01A03.pdf

Electro plans, pneumatics plans

complies

see list of
deficiencies

Q:\2003-01-VP\10003\DQB-ELEK03B01.pdf

Q:\2003-01-VP\10003\DQB-PNEU02B04.pdf

Project plan

complies

Q:\2003-01-VP\10003\DQP-PP02C02.pdf

The technical specification and order confirmation were compared with the following result:

Deviation

Evaluation

Measures

Compressed air requirement is higher than defined

Non-critical

Available pressure is sufficient. Exceeded by 12 %. Overall capacity is not jeopardised.

Control balance: change of type (successor)

Non-critical

Check as part of OQ

Risk analysis

The following risk analysis was carried out and documented by the project team based on the available data and experiences.

 

Company name

Logo

Design qualification report

Doc.no.

Blister pack line

Page x of y
valid from:

 

No.

Aspect/action

Effect

Solution

Critical

Measures

Moulded foils

1.

End of foil

Machine continues to run, products not packaged.

Fault detected by sensor: Machine stop or prevention of start; Failure message

yes

OQ-check

2.

Adhesive parts

Moulded foil adheres to packaging

Sensor: no product supply, ejection of packages

yes

OQ-check

3.

Tear in aluminium moulded foil

Machine continues operating

Tear check: sensor to detect faults,interruption in product feed

yes

OQ-check

Cover foils

4.

End of foil

Machine continues to run, products not packaged.

Fault detected by sensor: machine stop or prevention of start; failure message

yes

OQ-check

5.

Adhesive parts

Cover foil adheres to packaging

Sensor: no product supply, ejection of packages

yes

OQ-check

6.

Incorrect positioning of printed cover foil

Package has incorrect printing

Control of printed marks

yes

OQ-check

Foil feed

7.

Foil inserted incorrectly

unsuitable parameters, incorrect packages are rejected

Monitoring of rollers

yes

OQ-check

Heating station

8.

Temperature deviation

Insufficient heating or damage to the moulded foil

Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start

yes

OQ-check,
measuring point calibration

Moulding station

9.

Low compressed air level

Incorrect shape of wells

Monitoring of the compressed air, machine stops or start-up is prevented if there is negative pressure

yes

OQ-check,
measuring point calibration

10.

Insufficient cooling

Moulded foil damaged

Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start

yes

OQ-check,
measuring point calibration

11.

Clamping force insufficient

Incorrect shape of wells

Readjustment of the clamping force

yes

OQ-check,
measuring point calibration

Product supply

12.

Product feed not activated or in incorrect position

Empty packages

Linking of product feed (taking the pre-dosing option into consideration) and machine start-up in automatic mode

yes

OQ-check

13.

Holding tank empty

Empty packages

Content control for detection. Ejection of detected packages; Machine stop after defined number for production error

yes

OQ-check

14.

Imprecise positioning of the product in the wells

Product is protruding

Sensor: ejection of detected packages; Machine stop after defined number for production error

yes

OQ-check

15.

Incorrect, faulty products

Size of product and packaging material are incompatible

Content control, sensors

yes

OQ-check

Content control

16.

Incorrect camera position

Inadequate fault detection

Permanent fault detection, .machine stop after defined number for production error

yes

OQ-check

17.

Incorrect alignment of the lens

Inadequate fault detection

Permanent fault detection, .machine stop after defined number for production error

yes

OQ-check

18.

Content control not activated

No fault detection

Failure message

yes

OQ-check

19.

Content control defective

Inadequate fault detection

Machine stop or prevention of start

yes

OQ-check

Sealing station

20.

Anomalous sealing temperature display

Inadequate seal

Calibration of measuring system, test for tightness

yes

OQ-check,
measuring point calibration

21.

Anomalous sealing pressure display

Inadequate seal

Calibration of measuring system, test for tightness

yes

OQ-check,
measuring point calibration

22.

Imprecise positioning of the moulded and cover foil

inadequate seal

Alignment, tightness testing

yes

OQ-check

Coding

23.

Imprecise positioning

Coding in the wrong place or coding incomplete

Alignment, sample test

yes

OQ-check

24.

Deviating temperature

Inadequate coding or blister damage

Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start

yes

OQ-check

Measuring point calibration

25.

Incorrect types

Incorrect variable data

Sample test

yes

not applicable

Perforation station

26.

Blunt knife

Inadequate perforation

Sample test

yes

not applicable

27.

Incorrect tool

Incorrect perforation

Correction, sample test

yes

not applicable

Die-cutting station

       

28.

Blunt knife

Inadequate die cutting

Sample test

yes

not applicable

29.

Incorrect tool

Incorrect die cutting

Correction, sample test

yes

not applicable

Discharge

30.

Sucker damaged

Undamaged product falls into collecting tray for damaged product

Ejection controls

yes

OQ-check

31.

Ejection control fault

No detection of damaged product, which is not ejected

Failure message: machine stop or prevention of start

yes

OQ-check

Sorting device

32.

Incorrect alignment

Imprecise transfer to the subsequent process

Sensor monitoring

yes

OQ-check

33.

Sensor fault

Multiple transfer problems

Failure message to control

yes

OQ-check

Folding cartons

34.

Incorrect folding carton

Incorrect folding carton

Code reader

yes

OQ-check

35.

Low compressed air level

Incorrect sorting, stacking, transfer

Monitoring of the compressed air and vacuum control, machine stops or start-up is prevented

yes

OQ-check

36.

Incorrect number of blisters

Under or overfilling of folding cartons

Control balance, sensors

yes

OQ-check

Balance calibration

Folding carton coding

37.

Imprecise positioning

Coding in the wrong place or coding incomplete

Alignment, sample test

yes

not applicable

38.

Deviating temperature

Inadequate coding or blister damage

Sensors for automatic control of the actual temperatures (calibrated measuring system). Machine stop or prevention of start

yes

OQ-check

Measuring point calibration

39.

Incorrect types

Incorrect variable data

Sample test

yes

not applicable

Package insert

40.

Incorrect package leaflet

Incorrect package insert

Code reader

yes

OQ-check

41.

Package insert missing

No package insert

Code reader, lumat controls, ejection control, control balance

yes

OQ-check

42.

Packages closed incorrectly

Packages open and damaged

Sample control

yes

not applicable

Code reader

43.

Code reader not activated

No fault detection

Failure message

yes

OQ-check

44.

Code reader faulty

Inadequate fault detection

Machine stop or prevention of start

yes

OQ-check

45.

Reject control, ejection control insufficient

Incorrect packages

Failure message, machine stops

yes

OQ-check

Lumat reader

46.

Lumat reader not activated

No fault detection

Failure message

yes

OQ-check

47.

Lumat reader defective

Inadequate fault detection

Machine stop or prevention of start

yes

OQ-check

Transfer, control balance

48.

Control balance not activated

No fault detection

Failure message

yes

OQ-check

49.

Control balance defective

Inadequate fault detection

In-process check

yes

not applicable

50.

Reject control, ejection control insufficient

Incorrect packages

In-process check

yes

not applicable

Bundling machine

51.

Congestion transferring to bundling machine

Congestion in the shrinking tunnel: package bundles are heated before the outlet

Time recording and alarm if time is exceeded

yes

OQ-check

52.

Incorrect temperature

Insufficient shrinking or thermal load

Temperature monitoring

yes

OQ-check;
measuring point calibration

53.

Incorrect counting

Incorrect number of packages in the bundle

Sample test

yes

not applicable

Control

54.

Incorrect function process and displays

Machine functions faulty

Testing

yes

OQ-check

55.

Incorrect parameters

Machine functions faulty

Testing

yes

not applicable

56.

Critical functions or parameters are not adequately protected (password)

Settings made and modified by unauthorised (unqualified) personnel.

Hierarchical password system

yes

OQ-check

57.

System validity lacking

Reproducibility and product safety not guaranteed

Testing

yes

IQ, OQ-check

Energy supply

58.

Interruption in supply voltage

Loss of data. Restarting results in incorrect packages

Memory protected against zero voltage; noting and detecting positions and ejection volumes

yes

OQ-check

Generalities

59.

Operator error

Incorrect packages

Training, operating procedures, displays, messages, documentation procedures

yes

not applicable

Framework documents

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

Deficiencies list

Aspect

Description

Measure

Component list

Update after change is still outstanding. No effect on GMP aspects, therefore non-critical

Update

Pneumatics plan

Agreed change still to be updated in drawing. No effect on GMP aspects, therefore non-critical

Update

Result of the design qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the design qualification.

The level of design qualification is

x complete.
o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the installation qualification.

13.C.3 Installation qualification (IQ)

13.C.3.1 Installation qualification protocol

Company name

Logo

Installation qualification protocol

Doc.no.

Blister pack line

Page x of y

valid from:                       

compiles

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                             

Packaging unit (copy)                              

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"Objectives"

"Responsibilities"

"Checks"

"Documentation checking"

"Component checking"

"Test plans"

"Documents"

Objectives

The objective of the installation qualification is to document the correct implementation of the previously defined requirements for the manufacturing and assembly operations of the facility. The documentation contains information about identification of the overall scope of delivery of the pharmaceutical process equipment and confirmation that the supplied components correspond to the specifications that were defined during the draft phase.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the installation qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • DQ report
  • DQ deficiencies list
  • Installation drawing
  • Certificates (ISO, CE, free from asbestos)
  • Material specification of parts coming into contact with the product
  • Calibration list: List of measuring points, calibration procedures, suitability of measuring instruments
  • Technical documentation (maintenance schedule, user instructions, list of lubricants, list of filters, MSR list, pneumatics plan, media supply, equipment list, spare parts list)
  • QA machine acceptance by the suppliers
  • FAT records
Component checking

Check for the correct installation of the defined components:

  • Completeness and conformity with the plans
  • Pressure test (moulding station)
  • Test of the direction of rotation (motors)
  • Calibration (GMP-relevant measured sections for temperatures and pressures, balances (dynamic, static), camera systems, code readers; each with min./max./target value)

Check of aspects subject to CSV:

  • Software: version number
  • Plan for input/output, electrical diagram
  • Function plan with parameter list
  • Explanation of symbols and variables
  • Back-up file
Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below. The defined checks are carried out as part of the FAT. The various individual test plans are referred to in the FAT plan document.

FAT

File path

Specification for execution

Q:\QZ\FAT03A01.pdf

FAT protocol

Q:\2003-01-VP\10003\IQP-FAT01A01.pdf

Calibration

File path

Specification for execution

Q:\Kalib\TEMP04D01.pdf
Q:\Kalib\PRESSURE03C02.pdf

Foil heating, upper plate

Q:\2003-01-VP\10003\IQP-KAL01A02.pdf

Foil heating, lower plate

Q:\2003-01-VP\10003\IQP-KAL02A02.pdf

Moulding station cooling

Q:\2003-01-VP\10003\IQP-KAL03A02.pdf

Moulding station heating

Q:\2003-01-VP\10003\IQP-KAL04A02.pdf

Perforation heating

Q:\2003-01-VP\10003\IQP-KAL05A02.pdf

Coding heating

Q:\2003-01-VP\10003\IQP-KAL06A01.pdf

Sealing pressure 1

Q:\2003-01-VP\10003\IQP-KAL01B01.pdf

Sealing pressure 2

Q:\2003-01-VP\10003\IQP-KAL02B01.pdf

Manometer

Q:\Kalib\PRESSURE02E01.pdf

Component check

File path

Specification for execution

Q:\QZ\COMP03A02.pdf

Utilities

Q:\2003-01-VP\10003\IQP-COMP01A01.pdf

Electrics

Q:\2003-01-VP\10003\IQP-COMP02A02.pdf

Pneumatics

Q:\2003-01-VP\10003\IQP-COMP03A03.pdf

Overall configuration

Q:\2003-01-VP\10003\IQP-COMP04A02.pdf

CSV analysis

File path

Specification for execution

Q:\QZ\CSV04A01.pdf

Testing

Q:\2003-01-VP\10003\IQP-CSV01A03.pdf

Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ protocol

Q:\2003-01-VP\10003\IQP-IQP03A01.pdf

13.C.3.2 Installation qualification report

Company name

Logo

Installation qualification report

Doc.no.

Blister pack line

Page x of y

valid from:                                

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                          

Packaging unit (copy)                             

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"DQ deficiencies list"

"Checks"

"Documentation checking"

"Calibration"

"Component checks"

"Framework documents"

"Result of the installation qualification"

DQ deficiencies list

The following deficiencies have been documented as part of the design qualification. The current status has been checked.

Document

DQ status

IQ status

Component list

Update after change is still outstanding. No effect on GMP aspects, therefore non-critical

complete

Pneumatics plan

Agreed change still to be updated in drawing. No effect on GMP aspects, therefore non-critical

complete

Checks

Checks and activities are carried out as part of the installation qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document

Testing

File path

DQ report

complies

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

DQ deficiencies list

complies

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

Installation drawing

complies

Q:\2003-01-VP\10003\IQB-INSTZ02A03.pdf

Certificates (ISO, CE, free from asbestos)

complies
see list of deficiencies

Q:\2003-01-VP\10003\IQB-CERT01A03.pdf

Material specification of parts coming into contact with the product

complies

Q:\2003-01-VP\10003\IQB-CERT02A02.pdf

Calibration list: List of measuring points, calibration procedures, suitability of measuring instruments

complies

Q:\2003-01-VP\10003\IQP-CERT01K02.pdf

Document

Testing

File path

Technical documentation (maintenance schedule, user instructions, list of lubricants, list of filters, MSR list, pneumatics plan, media supply, equipment list, spare parts list)

complies

see list of deficiencies

Q:\2003-01-VP\10003\IQB-DOC05T01.pdf

Q:\2003-01-VP\10003\IQB-DOC07T01.pdf

Q:\2003-01-VP\10003\IQB-DOC08T01.pdf

Q:\2003-01-VP\10003\IQB-DOC10T01.pdf

Q:\2003-01-VP\10003\IQB-DOC12T01.pdf

Q:\2003-01-VP\10003\IQB-DOC13T01.pdf

Q:\2003-01-VP\10003\IQB-INST01A01.pdf

Q:\2003-01-VP\10003\IQB-INST02A02.pdf

Q:\2003-01-VP\10003\IQB-INST03A03.pdf

Q:\2003-01-VP\10003\IQB-DOC22T01.pdf

QA machine acceptance by the suppliers

complies

Q:\2003-01-VP\10003\IQB-DOC01QA01.pdf

FAT records

complies

Q:\2003-01-VP\10003\IQB-FAT01A01.pdf

Q:\2003-01-VP\10003\IQB-FAT02A01.pdf

Q:\2003-01-VP\10003\IQB-FAT03A01.pdf

Q:\2003-01-VP\10003\IQB-FAT04A01.pdf

Q:\2003-01-VP\10003\IQB-FAT05A01.pdf

Q:\2003-01-VP\10003\IQB-FAT06A01.pdf

Q:\2003-01-VP\10003\IQB-FAT07A01.pdf

Q:\2003-01-VP\10003\IQB-FAT08A01.pdf

Q:\2003-01-VP\10003\IQB-FAT09A01.pdf

Q:\2003-01-VP\10003\IQB-FAT10A01.pdf

Aspects subject to CSV

complies

Q:\2003-01-VP\10003\IQB-CSV01D01.pdf

Calibration

Document

Testing

File path

Film heating, upper plate

complies

Q:\2003-01-VP\10003\IQP-CAL01A02.pdf

Film heating, lower plate

complies

Q:\2003-01-VP\10003\IQB-CAL02A02.pdf

Moulding station cooling

complies

Q:\2003-01-VP\10003\IQB-CAL03A02.pdf

Moulding station heating

complies

Q:\2003-01-VP\10003\IQB-CAL04A02.pdf

Perforation heating

complies

Q:\2003-01-VP\10003\IQB-CAL05A02.pdf

Coding heating

complies

Q:\2003-01-VP\10003\IQB-CAL06A01.pdf

Sealing pressure 1

complies

Q:\2003-01-VP\10003\IQB-CAL01B01.pdf

Sealing pressure 2

complies

Q:\2003-01-VP\10003\IQB-CAL02B01.pdf

Manometer

complies

Q:\2003-01-VP\10003\IQB-CAL0D01.pdf

Balances (dynamic, static)

complies

Q:\2003-01-VP\10003\IQB-CAL01W01.pdf

Component checks

Document

Testing

File path

Code reader (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT01B01.pdf

Pressure vessel (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT02B1.pdf

Motor test (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT03B01.pdf

Utilities (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT04B01.pdf

Electrics (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT05B01.pdf

Pneumatics (see FAT)

complies

Q:\2003-01-VP\10003\IQB-FAT06B01.pdf

Total configuration
(see FAT)

complies
see list of
deficiencies

Q:\2003-01-VP\10003\IQB-FAT07B01.pdf

Framework documents

Document

Testing

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ plan

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ plan

Q:\2003-01-VP\10003\ICP-IQP03A01.pdf

IQ report

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

IQ deficiencies list

The following deficiencies have been determined based on the checks.

Aspect

Description

Measure

Certificates (free from asbestos)

Certificate to prove that there is no asbestos is still outstanding. Clarification from the vendor from his supplier.

Update

Technical documentation (maintenance schedule, spare parts list)

Maintenance schedule and spare parts list are not current

Update

Total configuration (see FAT)

Configuration could only be checked on individual machines. Total configuration is checked as part of OQ.

Check in OQ

Result of the installation qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the installation qualification.

The level of installation qualification is

x complete.

o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the operational qualification.

13.C.4 Operational qualification (OQ)

13.C.4.1 Operational qualification protocol

Company name

Logo

Operational qualification protocol

Doc.no.

Blister pack line

Page x of y

valid from:                                

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                            

Packaging unit (copy)                                  

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"Objectives"

"Responsibilities"

"Checks"

"Documentation checking"

"Function check"

"Test plans"

"Documents"

Objectives

The objective of the operational qualification is to check the correct operation of components in accordance with the operational specification.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the operational qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • IQ report
  • IQ deficiencies list
  • SOPs (cleaning, calibration, maintenance) available in at least draft format
Function check

Test for correct operation:

  • Safety devices (emergency off, etc.)
  • Test under normal and maximum conditions
  • Checks of the reaction to malfunctions
  • Aspects subject to CSV
Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below.

Safety devices

File path

Specification for execution

Q:\SFK\SFK05A04.pdf

Checks

Q:\2003-01-VP\10003\OQP-SFK01A01.pdf

The defined checks are carried out as part of the SAT. The various individual test plans are referred to in the SAT protocol document.  

SAT

File path

Specification for execution

Q:\QZ\SAT02A01.pdf

SAT protocol

Q:\2003-01-VP\10003\OQP-SAT01A01.pdf

    

Check of the reaction to malfunctions

File path

Specification for execution

Q:\QZ\STOER03A02.pdf

Check of splice point control (moulded foil)

Q:\2003-01-VP\10003\OQP-STR01A01.pdf

Check of splice point control (cover foil)

Q:\2003-01-VP\10003\OQP-STR02A01.pdf

Aluminium crack control check

Q:\2003-01-VP\10003\OQP-STR03A01.pdf

Check of end of foil control (moulded foil)

Q:\2003-01-VP\10003\OQP-STR04A01.pdf

Check of end of foil control (cover foil)

Q:\2003-01-VP\10003\OQP-STR05A01.pdf

Temperature control (lower heating plate)

Q:\2003-01-VP\10003\OQP-STR06A01.pdf

Temperature control (upper heating plate)

Q:\2003-01-VP\10003\OQP-STR07A01.pdf

Temperature control (sealing temperature)

Q:\2003-01-VP\10003\OQP-STR08A01.pdf

Temperature control (coding)

Q:\2003-01-VP\10003\OQP-STR09A01.pdf

Temperature control (perforation)

Q:\2003-01-VP\10003\OQP-STR10A01.pdf

Temperature control (moulding station cooling)

Q:\2003-01-VP\10003\OQP-STR11A01.pdf

Content control check

Q:\2003-01-VP\10003\OQP-STR12A01.pdf

Packaging rejection check (under sealer roller during machine stop)

Q:\2003-01-VP\10003\OQP-STR13A01.pdf

Machine stop (production error)

Q:\2003-01-VP\10003\OQP-STR14A01.pdf

Ejection control check

Q:\2003-01-VP\10003\OQP-STR15A01.pdf

Transfer control check

Q:\2003-01-VP\10003\OQP-STR16A01.pdf

Compressed air control check

Q:\2003-01-VP\10003\OQP-STR17A01.pdf

Vacuum control check

Q:\2003-01-VP\10003\OQP-STR18A01.pdf

Interruption of power supply check

Q:\2003-01-VP\10003\OQP-STR19A01.pdf

Triggering of motor protecting switch

Q:\2003-01-VP\10003\OQP-STR20A01.pdf

Print mark control outer web sensor check

Q:\2003-01-VP\10003\OQP-STR21A01.pdf

Leaflet feed check

Q:\2003-01-VP\10003\OQP-STR22A01.pdf

Folding carton feed check

Q:\2003-01-VP\10003\OQP-STR23A01.pdf

Incorrect package sorting check

Q:\2003-01-VP\10003\OQP-STR24A01.pdf

Blister stack check

Q:\2003-01-VP\10003\OQP-STR25A01.pdf

Overload check

Q:\2003-01-VP\10003\OQP-STR26A01.pdf

Code reader check (leaflet)

Q:\2003-01-VP\10003\OQP-STR27A01.pdf

Code reader check (folding carton)

Q:\2003-01-VP\10003\OQP-STR28A01.pdf

Lumat check

Q:\2003-01-VP\10003\OQP-STR29A01.pdf

Blister pack control

Q:\2003-01-VP\10003\OQP-STR30A01.pdf

Folding carton coding control

Q:\2003-01-VP\10003\OQP-STR31A01.pdf

Folding carton closure control

Q:\2003-01-VP\10003\OQP-STR32A01.pdf

Control (product in folding carton)

Q:\2003-01-VP\10003\OQP-STR33A01.pdf

  

CSV analysis

File path

Specification for execution

Q:\QZ\CSV04A01.pdf

Testing

Q:\2003-01-VP\10003\OQP-CSV02A02.pdf

Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ protocol

Q:\2003-01-VP\10003\IQP-IQP03A01.pdf

IQ report

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

OQ protocol

Q:\2003-01-VP\10003\OQP-OQP02A01.pdf

13.C.4.2 Operational qualification report

Company name

Logo

Operational qualification report

Doc.no.

Blister pack line

Page x of y

valid from:                                

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                              

Packaging unit (copy)                                         

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"IQ deficiencies list"

"Checks"

"Documentation checking"

"Function checks"

"Framework document"

"OQ deficiencies list"

"Result of the operational qualification"

IQ deficiencies list

The following deficiencies have been documented as part of the installation qualification. The current status has been checked.

Aspect

IQ status

OQ status

Certificates
(free from asbestos)

Certificate to prove that there is no asbestos is still outstanding. Clarification from the vendor from his supplier.

complete

Technical documentation (maintenance schedule, spare parts list)

Maintenance schedule and spare parts list are not current

complete

Total configuration (see FAT)

Configuration could only be checked on individual machines. Total configuration is checked as part of OQ.

complete

Checks

Checks and activities are carried out as part of the operational qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document

Testing

File path

IQ report

complies

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

IQ deficiencies list

complies

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

SOP:

complies

 

Maintenance

Calibration

Cleaning

 

SOP T1111-1draft

SOP T1111-15draft

SOP R1003-57draft

Function checks

Safety devices

Testing

File path

Analyses

complies

Q:\2003-01-VP\10003\OQP-SFK01A01.pdf

SAT

Testing

File path

SAT records

complies

Q:\2003-01-VP\10003\OQB-SAT01A02.pdf

Q:\2003-01-VP\10003\OQB-SAT02A02.pdf

Q:\2003-01-VP\10003\OQB-SAT03A03.pdf

Q:\2003-01-VP\10003\OQB-SAT04A01.pdf

Q:\2003-01-VP\10003\OQB-SAT05A02.pdf

Q:\2003-01-VP\10003\OQB-SAT06A01.pdf

Q:\2003-01-VP\10003\OQB-SAT07A01.pdf

 

Test under normal/maximum conditions

Testing

File path

Specification for execution

complies

Q:\QZ\NORM04Q03.pdf

Test of automatic operation (normal conditions)

complies

Q:\2003-01-VP\10003\OQB-NOR01A02.pdf

Test of automatic operation (maximum conditions)

complies

Q:\2003-01-VP\10003\OQB-NOR02A02.pdf

Test of inching operation (normal conditions)

complies

Q:\2003-01-VP\10003\OQB-NOR03A02.pdf

Test of inching operation (maximum conditions)

complies

Q:\2003-01-VP\10003\OQB-NOR04A02.pdf

Test of set-up operation

complies

Q:\2003-01-VP\10003\OQB-NOR05A02.pdf

Test of manual operation

complies

Q:\2003-01-VP\10003\OQB-NOR06A02.pdf

Timer test

complies

Q:\2003-01-VP\10003\OQB-NOR07A02.pdf

Check of production data collection

complies

Q:\2003-01-VP\10003\OQB-NOR08A02.pdf

Print mark control check

complies

Q:\2003-01-VP\10003\OQB-NOR09A02.pdf

Compressed air filter check (moulding station)

complies

Q:\2003-01-VP\10003\OQB-NOR10A02.pdf

Pre-dosage check

complies

Q:\2003-01-VP\10003\OQB-NOR11A02.pdf

Leaflet feed check

complies

Q:\2003-01-VP\10003\OQB-NOR12A02.pdf

Folding carton feed check

complies

Q:\2003-01-VP\10003\OQB-NOR13A02.pdf

Boxing check

complies

Q:\2003-01-VP\10003\OQB-NOR14A02.pdf

Balance check

complies

Q:\2003-01-VP\10003\OQB-NOR15A02.pdf

Bundling machine check

complies

Q:\2003-01-VP\10003\OQB-NOR16A02.pdf

 

 

Check of the reaction to malfunctions

Testing

File path

Specification for execution

complies

Q:\QZ\STOER03A02.pdf

Check of splice point control (moulded foil)

complies

Q:\2003-01-VP\10003\OQB-STR01A01.pdf

Check of splice point control (cover foil)

complies

Q:\2003-01-VP\10003\OQB-STR02A01.pdf

Aluminium crack control check

complies

Q:\2003-01-VP\10003\OQB-STR03A01.pdf

Check of end of foil control (moulded foil)

complies

Q:\2003-01-VP\10003\OQB-STR04A01.pdf

Check of end of foil control (cover foil)

complies

Q:\2003-01-VP\10003\OQB-STR05A01.pdf

Temperature control (lower heating plate)

complies

Q:\2003-01-VP\10003\OQB-STR06A01.pdf

Temperature control (upper heating plate)

complies

Q:\2003-01-VP\10003\OQB-STR07A01.pdf

Temperature control
(sealing temperature)

complies

Q:\2003-01-VP\10003\OQB-STR08A01.pdf

Temperature control (coding)

complies

Q:\2003-01-VP\10003\OQB-STR09A01.pdf

Temperature control (perforation)

complies

Q:\2003-01-VP\10003\OQB-STR10A01.pdf

Temperature control (moulding station cooling)

complies

Q:\2003-01-VP\10003\OQB-STR11A01.pdf

Content control check

complies

Q:\2003-01-VP\10003\OQB-STR12A01.pdf

Packaging rejection check (under sealer roller during machine stop)

complies

Q:\2003-01-VP\10003\OQB-STR13A01.pdf

Machine stop (production error)

complies

Q:\2003-01-VP\10003\OQB-STR14A01.pdf

Ejection control check

complies

Q:\2003-01-VP\10003\OQB-STR15A01.pdf

Transfer control check

complies

Q:\2003-01-VP\10003\OQB-STR16A01.pdf

Compressed air control check

complies

Q:\2003-01-VP\10003\OQB-STR17A01.pdf

Vacuum control check

complies

Q:\2003-01-VP\10003\OQB-STR18A01.pdf

Interruption of power supply check

complies

Q:\2003-01-VP\10003\OQB-STR19A01.pdf

Triggering of motor protecting switch

complies

Q:\2003-01-VP\10003\OQB-STR20A01.pdf

Print mark control outer web sensor check

complies

Q:\2003-01-VP\10003\OQB-STR21A01.pdf

Leaflet feed check

complies

Q:\2003-01-VP\10003\OQB-STR22A01.pdf

Folding carton feed check

complies

Q:\2003-01-VP\10003\OQB-STR23A01.pdf

Incorrect package sorting check

complies

Q:\2003-01-VP\10003\OQB-STR24A01.pdf

Blister stack check

complies

Q:\2003-01-VP\10003\OQB-STR25A01.pdf

Overload check

complies

Q:\2003-01-VP\10003\OQB-STR26A01.pdf

Code reader check (leaflet)

complies

Q:\2003-01-VP\10003\OQB-STR27A01.pdf

Code reader check (folding carton)

complies

Q:\2003-01-VP\10003\OQB-STR28A01.pdf

Lumat check

complies

Q:\2003-01-VP\10003\OQB-STR29A01.pdf

Blister pack control

complies

Q:\2003-01-VP\10003\OQB-STR30A01.pdf

Folding carton coding control

complies

Q:\2003-01-VP\10003\OQB-STR31A01.pdf

Folding carton closure control

complies

Q:\2003-01-VP\10003\OQB-STR32A01.pdf

Control (product in folding carton)

complies

Q:\2003-01-VP\10003\OQB-STR33A01.pdf

  

CSV test

Testing

File path

Testing

complies

Q:\2003-01-VP\10003\OQB-CSV02A02.pdf

Framework document

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ protocol

Q:\2003-01-VP\10003\ICP-IQP03A01.pdf

IQ report

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

OQ protocol

Q:\2003-01-VP\10003\OQP-OQP02A01.pdf

OQ deficiencies list

The following deficiencies have been determined based on the test/checks.

Aspect

Description

Measure

not applicable

not applicable

not applicable

Result of the operational qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the operational qualification.

The level of operational qualification is

x complete

o not complete

A deficiencies list is an integral part of the document and is included as part of the plan for the operational qualification.

13.C.5 Performance qualification (PQ)

13.C.5.1 Performance qualification protocol

Company name

Logo

Performance qualification protocol

Doc.no.

Blister pack line

Page x of y

valid from:                                 

compiled

Name/function

Date

Signature

Head of qualification

                                             

                                             

checked

Head of project

                                             

                                             

Head of process technology

                                             

                                             

approved

Head of packaging unit

                                             

                                             

Head of quality assurance

                                             

                                             

Archiving

Quality assurance (original)                          

Packaging unit (copy)                                  

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"Objectives"

"Responsibilities"

"Checks"

"Documentation checking"

"Function check"

"Test plans"

"Documents"

Objectives

The objective of the performance qualification is to check the correct operation of the facility in accordance with the technical specifications.

Responsibilities

The responsibilities for this project are established in MQP.

Checks

Checks and activities are carried out as part of the performance qualification:

Documentation checking

Document check regarding presence, completeness and approval:

  • OQ report
  • OQ deficiencies list
  • SOPs (cleaning, calibration, maintenance)
  • Personnel training
Function check

The performance tests are carried out essentially for blister thickness and running characteristics in the upper, middle and lower adjustment ranges of the facility (temperature, pressure, speed) which are defined in the technical specifications. The tests use the target formats for contents and packaging material (folding carton, leaflets) that are established in the technical specifications.

Test plans

The relevant test plans including the acceptance criteria and specifications for execution are in the documents listed below. The placebo batches used for the tests are documented in the records.

Tests

File path

Specification for execution

Q:\QZ\PQ02Q03.pdf

Format 1 (min, max. average), packaging material format 1

Q:\2003-01-VP\10003\PQP-T01A01.pdf

Format 2 (min, max. average),
packaging material format 1

Q:\2003-01-VP\10003\PQP-T02A02.pdf

Format 2 (min, max. average),
packaging material format 2

Q:\2003-01-VP\10003\PQP-T03A01.pdf

Format 1 (min, max. average),
packaging material format 2

Q:\2003-01-VP\10003\PQP-T04A02.pdf

Control systems check

Q:\2003-01-VP\10003\PQP-T05A03.pdf

Documents

The following documents have already been compiled during the initial stages of the project or are available as a draft version.

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ protocol

Q:\2003-01-VP\10003\IQP-IQP03A01.pdf

IQ report

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

OQ protocol

Q:\2003-01-VP\10003\OQP-OQP02A01.pdf

OQ report

Q:\2003-01-VP\10003\OQB-OQB02A02.pdf

13.C.5.2 Performance qualification report

Company name

Logo

Performance qualification report

Doc.no.

Blister pack line

Page x of y

valid from:                          

Name/function

Date

Signature

Head of qualification

   

checked

Head of project

                                                

                                                

Head of process technology

                                                

                                                

approved

Head of packaging unit

                                                

                                                

Head of quality assurance

                                                

                                                

Archiving

Quality assurance (original)                                

Packaging unit (copy)                                 

Document modification index

Version

Changes

Date

1

New facility

see signature

Contents

"OQ deficiencies list"

"Tests"

"Documentation checking"

"Function checks"

"Framework document"

"Result of the operational qualification"

"PQ deficiencies list"

"Result of the performance qualification"

OQ deficiencies list

No deficiencies have been determined based on the tests.

Document

File path

Document

not applicable

not applicable

not applicable

Tests

Tests and activities are carried out as part of the operational qualification:

Documentation checking

The presence, completeness and approval have been checked in accordance with the qualification plan.

Document

Testing

File path

OQ report

complies

Q:\2003-01-VP\10003\OQB-OQB02A02.pdf

IQ deficiencies list

complies

Q:\2003-01-VP\10003\OQB-OQB02A02.pdf

SOP:

Maintenance

Calibration

Cleaning

complies

SOP T1111-1

SOP T1111-15

SOP R1003-57

Personnel training

complies

Q:\TRAIN\VP\1753A1.pdf

Function checks

Aspects

Testing

File path

Format 1 (min, max. average), packaging material format 1

complies

Q:\2003-01-VP\10003\PQB-T01A01.pdf

Format 2 (min, max. average), packaging material format 1

complies

Q:\2003-01-VP\10003\PQB-T02A02.pdf

Format 2 (min, max. average), packaging material format 2

complies

Q:\2003-01-VP\10003\PQB-T03A01.pdf

Format 1 (min, max. average), packaging material format 2

complies

Q:\2003-01-VP\10003\PQB-T04A02.pdf

Control systems check

complies

Q:\2003-01-VP\10003\PQB-T05A03.pdf

Framework document

Document

File path

Qualification plan

Q:\2003-01-VP\10003\MQP-01A01.pdf

DQ protocol

Q:\2003-01-VP\10003\DQP-DQP01A02.pdf

DQ report

Q:\2003-01-VP\10003\DQB-DQB01A02.pdf

IQ protocol

Q:\2003-01-VP\10003\ICP-IQP03A01.pdf

IQ report

Q:\2003-01-VP\10003\ICB-ICB02A02.pdf

OQ protocol

Q:\2003-01-VP\10003\OQP-OQP02A01.pdf

OQ report

Q:\2003-01-VP\10003\OQB-OQB02A02.pdf

PQ protocol

Q:\2003-01-VP\10003\PQP-PQP01A01.pdf

PQ deficiencies list

The following deficiencies have been determined based on the checks.

Aspect

Description

Measure

not applicable

not applicable

not applicable

Result of the performance qualification

The checks and activities have been carried out in accordance with the specifications of the qualification plan for the performance qualification.

The level of operational qualification is

x complete.

o not complete

A list of deficiencies has been finalised.

The facility is qualified and released for production.

All changes to the facility are subject to the change control procedure (SOP A1000CC05).

Summary

As part of the preparation, measures must be established before commencing the actual packaging process to prevent confusion or mix-ups.

The first stage of facility approval is line clearance after cleaning out the previous product. Once the facility has been set up, step by step, a first process sample is checked with regard to the specifications and the variable data so that production can be approved if the results are consistent.

During operation, the process is constantly checked by test devices in the facility and repeated verification of the functionality of control devices by the personnel. This is supplemented by checks of packaged products.

The function check and controls of packaged products, together with the approval of the facility for production, can be seen as in-process controls. The allocation of designated groups of people within the personnel is unit specific.

Variable data, which is afixed during the packaging process, must meet requirements with regard to readability, accuracy and constancy. There are various techniques which can be used for this purpose.

An important step at the end of a packaging process is the reconciliation of the packaging material. The significance of this process depends on the overall design of the facility and the process.



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