In June 2022, the European Medicines Agency (EMA) published its first review of the 3-year work plan for the Quality domain (covering January 2021 to December 2023), highlighting interesting strategies and goals applicable to the Life Sciences industry. A second review is available here.
What is the Quality Domain?
The Quality domain is one of five EMA domains, comprising different collaborating parties. These parties advise and perform strategic, tactical, operational, reactive, educational, and stakeholder activities related to regulatory procedures and scientific guidelines applicable to medicinal products.
The Quality domain produces a work plan with strategic plans based on the priorities of EMA and of the European medicines regulatory network.
What is the Work Plan for the Quality Domain?
The so-called “Work Plan for the Quality Domain” is a 3-year plan of the GMDP Inspectors Working Group (IWG) that states the strategic, tactical, and operational goals to protect public health.
The current plan pays particular attention to supply chain integrity and resilience, product Quality and the impact of new manufacturing technologies on the supply chain.
This plan is closely aligned with the five goals of the Network Strategy and Regulatory Science Strategy (RSS) for 2025 to protect public health:
Who Are the GMDP Inspectors Working Group?
The GMDP IWG is a group of senior GMDP inspectors who represents the European Economic Area member states, the European Commission, the European Directorate for the Quality of Medicines & Healthcare (EDQM), and the inspectorates of countries accessing the EU and MRA (Mutual Recognition Agreements).
The group meets four times a year to discuss areas of common interest concerning GMDP inspections, develop new and GMDP-related guidance, and other GMDP issues, all in collaboration with other organizations such as PIC/s (Pharmaceutical Inspection Co-operation Scheme) and EDQM (European Directorate for the Quality of Medicines & HealthCare).
The group publishes a work plan every year, which becomes the basis for the discussions between this group, the EMA, and the Quality Working Party.
What Activities Does the 3-Year Work Plan for the Quality Domain Include?
This plan includes both specific and routine activities to achieve several strategic objectives. The tactical goals of the plan focus on the five Network Strategy 3.5 Goals 1 through 5 as well as Regulatory Science Strategy Goal 1:
Network Strategy 3.5 Goal 1
Enhance traceability, oversight, and security in the human/veterinary medicine supply chain.
Network Strategy 3.5 Goal 2
Enhance inspector capacity building at the European Union and international levels.
Network Strategy 3.5 Goal 3
Reinforce the responsibility for product Quality by harmonizing and reinforcing guidance.
Network Strategy 3.5 Goal 4
Encourage supply chain resilience and review long-term risks resulting from dependency on a limited number of manufacturers and sites.
Network Strategy 3.5 Goal 5 and Regulatory Science Strategy Goal 1
Catalyzing the integration of science and technology in medicines development.
It is important to highlight that part of the 3-year work plan derives from the Nitrosamines Lessons Learned Report (NLLR). This report includes findings from the lessons learned exercise after N-nitrosamine impurities were present in sartan active pharmaceutical impurities. The sartan incidents of 2018 raised important issues in the EU, leading to risk to patients and recalls. The report recommends ways to prevent N-nitrosamines and other unexpected impurities from being present in medicines and to better manage such cases in the future.
The plan also includes activities to revise some EU GMP:
|
Guidelines |
Target Date |
Status |
Comments |
|
Annex 1 - Manufacture of Sterile Medicinal Products |
Q1 2022 |
New: Reviewed August 22, 2022 |
Dates for coming into operation:
|
|
Chapter 4 - Documentation |
Q1 2026 |
To work |
A final text will assure data integrity in the context of GMPP. |
|
Annex 11 - Computerised Systems |
Q1 2026 |
To work |
|
|
Annex 15 - Qualification and Validation |
Q2 2024 |
Ongoing, following up on LLE recommendations |
Review the annex with regard to new technology in facilities, products, and processes; consider whether updates are necessary to extend it to APIs. |
|
Annex 16 - Certification by a Qualified Person and Batch Release |
Q4 2024 |
Ongoing, following up on LLE recommendations |
Review the annex to provide additional guidance on batch traceability. |
|
Chapter 1 - Pharmaceutical Quality System |
Q4 2023 |
Pending |
Submit the final text for the amended chapter to encourage industry adoption of risk-based approaches to prevention of shortages, taking account of initiatives such as the HMA-EMA Taskforce and industry inter-association guidelines. |
|
Annex 4 - Manufacture of Veterinary Medicinal Products Other than Immunological Veterinary Medicinal Products |
Q4 2024 |
To review comments received |
Update the document after reviewing all comments received from the concept paper stakeholder consultation. To provide the European Commission with a final text. |
|
Annex 5 - Manufacture of Immunological Veterinary Medicinal Products |
Q4 2024 |
To review comments received |
Update the document to respond to received comments from the concept paper stakeholder consultation. To provide the European Commission with a final text. |
|
New Guide - GMP specific to Advanced Therapy Medicinal Products |
Q4 2024 |
Ongoing |
Review the Guidelines according to the new Annex 1 if applicable. |
|
New Guide - GMP for Autogenous Veterinary Vaccines |
Q4 2023 |
Ongoing |
Provide the European Commission with a final text. |
|
New Guide - GMP |
Q4 2023 |
Ongoing |
Provide the European Commission with a final text. |
|
ICH Q9 - Quality Risk Management |
Q4 2023 |
Ongoing |
Support the Expert Working Group (EWG) in developing the training materials on ICH Q9 with particular emphasis on risk identification and risk management, in liaison with the dedicated PIC/S expert circle. |
|
GMP and Marketing Authorisation Holders |
Q4 2023 |
Ongoing |
Revise the paper in line with recommendations from the Nitrosamines LLE. |
|
ICH Q12 - Lifecycle management |
Q4 2023 |
Ongoing |
Support the Expert Working Group (EWG) in developing the training materials on ICH Q12 with particular emphasis on GMP inspection and Pharmaceutical Quality System aspects. |
|
ICH Q7 - GMP for Active Substances |
Q4 2023 |
Ongoing |
Support the Expert Working Group (EWG) in developing the guideline and following up on LLE recommendations to make Annex 15 mandatory for API through inclusion in Q7. |
|
ICH Q13 - Continuous Manufacturing |
Q4 2023 |
Ongoing |
Support the Expert Working Group (EWG) in developing the guidelines. |
|
VICH - GMP for API’s for Veterinary Medicines |
Q4 2023 |
Ongoing |
|
|
VICH - Other Q Guidelines for Veterinary Medicines |
Q4 2023 |
Ongoing |
Support the Expert Working Group (EWG) in any future adaptations of existing ICH Q Guidelines, such as Q9/Q10 to veterinary medicines. |
Conclusion
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