Target date

Q4 2023

Comments

To provide the European Commission with a final text for the amended chapter in order to encourage industry adoption of risk-based approaches to prevention of shortages, taking account initiatives such as HMA-EMA Taskforce and the industry inter-association guidelines.

Target date

Q4 2023

Comments

To provide the European Commission with a final text for the amended chapter in order to assure data integrity in the context of GMP. This would  be in parallel with similar consideration of Annex 11 (Computerised Systems).

Target date

Q4 2022

Comments

To provide the European Commission with a final text for the amended  annex in order to assure data integrity in the context of GMP. This would be  in parallel with similar consideration of Chapter 4 (Documentation).

Target date

Q2 2023

Comments

Review the annex in the light of new technology in facilities, products and processes and consider whether any updates are necessary. Following up on LLE recommendations, consider whether the scope can be extended to APIs.

Target date

Q2 2023

Comments

Following up on LLE recommendations, consider revision of annex in order to provide additional guidance on batch traceability.

Target date

Q4 2023

Comments

To revise the paper in line with recommendations from the Nitrosamines  LLE, to strengthen guidance for MAHs in terms of having adequate quality agreement with manufactures.