1 Necessity

Technical documentation comprises the recording, organisation, and archiving of technically-relevant documents and data, as well as their provision for information purposes (dtv, 1984). It is used to present procedural sequences and general technical conditions in a reproducible and up-to-date form. What does technical documentation have to do with GMP? Chapter 4.26 of the EU GMP Guideline states: "There should be written procedures and the associated records of actions taken or conclusions reached, where appropriate, for:[...], equipment assembly and calibration, maintenance, [...]. "Clear operating procedures should be available for major items of manufacturing and test equipment. "[EU GMP Guideline, chapter 4.27].

In order to satisfy the requirements of the EU GMP Guideline, the technical documentation is just as necessary as the qualification of rooms and facilities. Analogous to the basic principles of the documentation contained in chapter 4 of the EU GMP Guideline, the technical documentation is also a part of the quality assurance. If no technical documentation exists, it will not be possible either to install, qualify and operate facilities or calibrate, repair or maintain them. Important prerequisites for the usefulness of the technical documentation are: Absence of errors, relevance to the current situation, clarity, unambiguity, completeness and comprehensibility.

The technical documentation is for the most part compiled by the machine suppliers. Incomplete, incorrect or defective documentation should be rejected. To avoid this situation, it is advisable that the manufacturer of the machine has the documentation checked, approved and released by competent authorised persons prior to delivery. For more extensive documentation, it may be expedient for the users to receive instruction from the supplier, e.g. as part of training courses. In the interests of comprehensibility and bearing in mind the range of users, it is worth requesting that overseas manufacturers provide the most important sections in the local language.

2 Scope and content

The documents in figure 1 are an important part of the technical documentation (also see general requirements, chapter 4 EU GMP Guideline).

In the interests of clarity, easy handling of documentation, and reduced search times, all technical documents should be structured in the same way.
Figure 2.

contains an example of this:

A good way of standardising the technical documentation is to work out checklists (see figure 3, figure 4, figure 5). These lists are helpful when specifying new facilities and they simplify the review of the technical documentation during qualification.

A great deal of information, usually drawings, but also increasingly operating instructions, bills of materials, etc. is being stored on data media. In order to ensure that the available documents are compatible and therefore useful, the supplier and customer must arrange in good time which data medium and data formats should be used. The Internet provides an interesting option in this case as online access to the supplier's server means that the necessary information can be downloaded directly with the following benefits: the information is up-to-date and no administrative effort is required.

3 Administration of the technical documentation

Not least due to ISO certification (see chapter chapter 1 Quality Management), there is widespread acceptance amongst manufacturers of machines that equipment is incomplete where appropriate documentation is lacking. Many malfunctions and ambiguities that lead to questions being raised as to whether the equipment should be accepted or not can be avoided by providing complete technical documentation. The scope of the technical documentation increases with the complexity of the machines. Nowadays, it is not unusual for as many as twenty folders of equipment documentation to be required, and so the necessity to administer and tend of this mass of paperwork and data as well as develop suitable systems to deal with it, is unavoidable.

A system for technical documentation is characterised by established archiving modalities (see figure 6).

An example of uniform structuring is shown in figure 2.

The definition of an identification system (e.g. using code numbers) is particularly important, especially in the case of centrally archived systems. However, defined numbering is also highly recommended where decentralised storage systems are used and where the document administration is to be carried out electronically. For engineering drawings, the introduction of a "descriptive" numbering system is recommended.

Change control: (see chapter 19.C Change control) The effort required to keep everything up-to-date on an ongoing basis cannot be underestimated and a pragmatic approach should therefore be adopted. For example, the frequency of the updates may be dependent on the quality relevance of the technical change and secondary changes can be dealt with by cyclical updates, e.g. once a year. If the change affects the quality of the product the technical documentation must be modified immediately, irrespective of whether the change is planned or is made as a result of a malfunction.

Figure 7 shows the relationship between the cyclical updates and changes that are subject to mandatory requalification for qualification, technical and calibration documentation and maintenance schedules.

For technical documentation, version management is a prerequisite for the availability of clear and up-to-date information. For documentation stored on data media, particularly software documentation, this is essential.

Clear arrangements regarding access control and responsible persons must be made. To prevent copies being made that are uncontrollable and therefore not subject to updates, the original documentation must be accessible only to authorised individuals and any lending/borrowing must be documented (see figure 8). In practice it is recommended that one or several working copies, subject to updates, are handed out (see chapter 15.D.8 Administration).

4 Log book

"Log books should be kept for major or critical equipment recording, as appropriate, anyvalidations, calibrations, maintenance, cleaning or repair operations, including the dates andidentity of people who carried these operations out." (EU GMP Guideline, chapter 4.28) Chapter 4.29 of the EU GMP Guideline additionally states that "Log books should also record in chronological order the use of major or critical equipment and the areas where the products have been processed."

Log books must be kept and stored on-site, i.e. in the room or at the facility. Following CFR 211.180, log books must be retained for at least 1 year after the expiration date of the batch manufactured on the facility. However, to reduce administrative expenditure it is recommended that a standard retention time for log books be defined, e.g. 6 years (expiration date of the medicinal product batch: 3 years, plus safety margin: 3 years). This ensures that log books will still be retained once the machines and rooms have been decommissioned.

Entries must be made on-site in chronological order by the person carrying out the task(s). The entries must be confirmed by the signature of another person who is overseeing the task and must be made promptly, i.e. when the current task is being carried out - the signing may be carried out after completion. Entries and changes in the documentation must be carried out in accordance with the requirements of the EU GMP Guideline. (See chapter chapter 15 Documentation, (see chapter 15.B GMP-conforming documentation).

In the interests of simple handling, it is recommended that a standard log book is compiled for use in all the necessary areas. The assignment of log books to facilities or rooms must be facilitated through clear labelling. The individual pages of the log book must be consecutively numbered. An example of a general purpose log book can be found in figure 10 Log book (example). Special features of an area may be recorded in the log books using the "facility-specific area" column.