1. Re-inspection of production sites: preparation of CAPA plans and their implementation
GMP-inspection. Part 1
, Quality director, Maklakova Olga

2. Products range’s increase
Inspection’s types
Inspection type
The core process
Communications
Products range’s increase without inspection
Dossier filing and submission
Production site RA
Russian authorized representative
Products range’s increase with inspection
Self-inspection with the support of Russian authorized representative
Familiarization
with Russian regulatory requirements
The status of implementation of CAPA
to inspection, efficiency
Re-certification
САРА are fulfilled according to the submitted CAPA plan in terms,
Their efficiency is reviewed
Year
1-st certification
Products range’s increase
2-nd certification
2016 6
2017 1
2018 3
2019
2020

3. Manufacturer's problems/questions during re-inspection
САРА are not fulfilled partly
For the products are planned for registration: do not submit “an idea”.
Products certifies according documentary inspection should have GMP and license’ compliance;
САРА are not formally completed with no proven effectiveness;
САРА, filed in the post-inspection period are not reflected in the Pharmaceutical Quality System;
Not САРАs but correction is done, the impact on the related cases is not estimated,
During the re-inspection more attention is paid toPhQS, the attention and analysis form a senior management’s side.

4. Expectations/suggestions for re-inspection:
  Take into account the positive history of a producer at the Russian market, take into account the conscientiousness of the producer, for example: the absence of official complaints, recalls on the initiative of the producer
To implement the practice of «short» certification on the basis of the positive history;
During the products range increase to make the focus to the submitted product;
During re-inspection to recognise the positive trend for a producer;
When a refusal is received to make conclusion on the basis of САРАs;
САРАs, which depend on investments / or time-consuming processes (e.g. stability, validation): to accept with the planned dates but not fully done.