Annex 16

Question 1

Batch release is a 3 step process:

Answer 1

• Checking manufacture and testing is in accordance with defined release procedures
  
  • Certification by a QP signifying that the batch is in compliance with GMP and the MA

This represents the quality release of the batch
* Transfer to saleable stock, and/or export

Question 2

SAMPLING OUTSIDE OF EU NEED TECHNICAL JUSTIFICATION WITH RISK ASSESSMENT, INCLUDING

Answer 2

Audit of manufacturing and sampling Scientific study to include:
* Description of sampling process, transport conditions, comparative analysis and time limit between sampling and importation Random, periodic analysis of bulk after import Review of any unexpected or confirmed OOS result

Question 3

Three points, the QP must ensure in person:

Answer 3

• Certification is permitted by the MIA
  
  • National legislation is complied with
  • Certification is recorded in a register or equivalent 21 other points QP has to ensure but may delegate

Question 4

Unexpected deviations

Answer 4

All registered specifications must be met
QP may still certify when:
* The deviation is relates to the manufacturing process and/or the analytical control methods
* Deviation is thoroughly investigated and root cause corrected
* Variation submitted where appropriate for future production

A risk assessment conducted to include:
* Evaluation of the potential impact of the deviation on quality, safety or efficacy of the batch(es) and conclusion
* that the impact is negligible
* Consideration of the need to include the affected batch(es) in the ongoing stability programme

For biological medicinal products, consideration that any deviations from the approved process can have an unexpected impact on safety and efficacy