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Результаты инспектирования

Добавлено: 07 мар 2016 15:23
Spanish Agency of Medicines and Medical Devices выявил критические замечания на заводе FARMA MEDITERRANIA, S.L.

Nature of non-compliance:
Critical deficiencies
a) Lack of an effective pharmaceutical quality assurance system
b) Release of batches of medicinal products produced without completing all of the manufacturing protocols, without being checked quality assurance unit and without the approval of the technical director.
c) Use in quality control a non-qualified chromatographic equipment, with operating faults and an with an unvalidated computerized management system. As a result, the integrity, reliability, up-to-dateness, originality and authenticity of the data that are obtained cannot be guaranteed.
d) Transfer of some of the final analytical quality controls of medicinal products to a third party, without appropriately transferring the control methods and without the authorization of the relevant health authority
e) Manufacture of medicinal products using procedures that have not been appropriately validated or have not been periodically revalidated.
f) Acceptance of results of repeated analytical controls and sterility tests of finished medicinal products without having undertaken an in-depth investigation to determine the root cause of a previously result obtained which was out of specifications.
g) Although a visual inspection of injectable medicinal products reveals a high number of critical quality defects (the presence of visible particles) non deviations are opened and is not investigated.
c) Do not do any quality control on a statistical sample of units of injectable medicinal products that have passed the visual inspection.

Major deficiencies
a) Do not do the annual quality product review of medicinal products manufactured.
b) Deviations in the manufacturing processes are not investigated suitably and in-depth.
c) The simulation of the aseptic manufacturing process is not performed every six months and samples used in the simulation are not incubated at the right temperature.
c) The air treatment system in manufacturing areas is not properly qualified, as it is only checked when it is “at rest” but not “in operation”.
e) Medicinal products are manufactured without full compliance with conditions established in the marketing authorisation dossier and/or without carrying out all the established process controls.
f) Manufacturing and quality control documents of each batch of medicinal products manufactured are not filed correctly.
g) The facilities have been modified considerably without the authorization of the relevant health authority h) Test of growth promotion of culture media, which are used in the sterility testing, in the simulation of the aseptic manufacturing process or in the environmental control of critical manufacturing areas, is not carried out.
h) Do not analyse all of the specification parameters for raw materials used in the manufacturing.

Регуляторный орган Франции выявил 45 замечаний на заводе THERAVECTYS - VILLEJUIF

Добавлено: 07 мар 2016 15:34
Регуляторный орган Франции (French National Agency for Medicines and Health Products Safety) выявил 45 замечаний на заводе THERAVECTYS - VILLEJUIF (Франция), при проверке производства имунологических продуктов и продуктов для генной терапии

Nature of non-compliance :
An inspection performed by ANSM from 17 to 20 November 2015 raised 45 deficiencies, including 5 critical deficiencies and 17 major deficiencies on the following topics: 1) The implementation of exemption SOP for manufacturing operations which is not compliant to GMP principles, for example, Media Fill Test were performed with unqualified equipment. 2) The lack of sample area for incoming materials and their systematic use in quarantine status for manufacturing operations. 3) Appropriate measures in terms of monitoring locations, alert and action limits rationale, were not set for particle and microbiological monitoring in clean rooms grade A and B. 4) No protocol for clean rooms’ qualification was established and clean rooms classification didn’t fulfill ISO14644 requirements. 5) Some analytical methods and process were not validated for the clinical trial EudraCT : 2015-000845-21. Following the inspection, Theravectys decided to stop the production on going, to reject the 2 manufactured investigational batches and to withdraw the authorisation’s request for which the ANSM assessment was on going, for the clinical trial EudraCT : 2015-000845-21. No investigational batch was distributed.

Action taken/proposed by the NCA :
Suspension of the manufacturing authorisation No. F 15/154 in Part
Suspension of manufacturing operations of investigational medicinal products including quality control testing and batch certification. Storage activities are allowed.