Waiting for Eurasian Union GMP inspection. Gap-analysis from the point of view of the Russian manufacturer

Transcription

1 Waiting for Eurasian Union GMP inspection. Gap-analysis from the point of view of the Russian manufacturer Maklakova Olga, Quality director Kazan, 2018

2 Facilities 1 solid formsworkshop 1 semi-solid formsworkshop QC centre R&D FG&RM warehouse complex Customs Warehouse Pharmaceutical Warehouse 2

3 Core GMP audits, Inspections result, 2017 March, 2017: Belarus MoH semi-solids June, 2017: MSD-solids July, 2017:J&J solids October, 2017: PPH QA corporate December, 2017: MIT semi-solids+3pl WH Mock-up MIT and GMP inspectorate, 2018 RUS GMP inspectorate and 2 tutors from Denmark: February,

4 Topical issues for a manufacturer in preparation for the EAEU GMP How interesting is the certification of the EAEU or the availability of the Russian GMP is enough? Is it enough to prepare and submit a dossier in the CTD format for the successful certification? What is the difference between GMP EU/GMP RUS/GMP EAEU? What must be done to pass the inspection successfully? Which terms do we need to be ready? What about CAPEX/OPEX? Is there enough expertise and knowledge for the successful certification? 4

5 GAP- analysis, participants, actions. The expert group for evaluation : - QA - Production - WH - Supply Chain - QC - Engineering - Design department The main blind spots" for a typical Russian manufacturer : Shared facilities (the approach) Data integrity Cleaning validation, PDE CPP and CQA, process validation and continiuos verification, statistical evaluation Transportation routes verification 5

6 Gap-analysis. Examples. Chapter 2. Personnel. GAP Budget Findings at the audits 1 The job descriptions of QPs, QC head, Production head does not include additional duties and responsibilities in accordance with the requirements of EAEU GMP. QP should receive additional education требуется пройти дополнительное обучение in a number of disciplines, according directive ЕAEU 73. -/2.6. Education, training and work experience of QP must meet the requirements of the Member State. Yes - 2 There is no concept of "consultants "and requirements for education and experience of consultants in the procedure SOP001669"GMP training system." -/2.23. Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants. No - 6

7 Chapter 5. Production. GAP Budget Findings at the audits 3 4 The rules of GMP Guideline of the Russian Federation do not define an approach based on the minimization of tests. - / Manufacturers of finished products are responsible for any testing of starting materials as described in the marketing authorisation dossier. They can utilise partial or full test results from the approved starting material manufacturer but must, as a minimum, perform identification testing of each batch according to Annex 8. Transportation of samples of starting materials to third parties is carried out without monitoring the conditions of transportation. - /5.36. Special attention should be paid to the distribution controls (transport, wholesaling, storage and delivery) in order to maintain the quality characteristics of the starting materials and to ensure that test results remain applicable to the delivered material No - Yes - 5 Excipients and excipient suppliers approach is not based on the results of a formalised quality risk assessment - / Excipients and excipient suppliers should be controlled appropriately based on the results of a formalised quality risk assessment No - 7

8 Chapter 8. Complaints and product recall. GAP Budget Findings at the audits 6 Complaints activities with organizations of Member States to which products are exported are regulated by contracts. There is no information clause in the contracts in which no recall action is being proposed for a defective batch (e.g. with a short shelf life). -/8.25. /Principle The Competent Authorities should also be informed in situations in which no recall action is being proposed for a defective batch because the batch has expired (such as with short shelf-life products.) No - 8

9 Thank you!