NAFDAC WORKSHOP ON ICH Q1 AND Q7 GUIDELINES AND ITS IMPLEMENTATION
The National Agency for Food and Drug Administration and Control (NAFDAC), in partnership with Northeastern University, USA, and the International Council for Harmonization (ICH), successfully organized a workshop on ICH Q1 Stability Guidelines and ICH Q7 Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (API) from July 22nd to 25th, 2024.
This workshop brought together regulators from the West African region, pharmaceutical manufacturers, and academia, aiming to build the capacity necessary for enhancing the technical competence of both regulators and industry professionals. The focus was on developing skills related to designing stability programs, conducting stability testing, quality control of finished pharmaceuticals, and understanding GMP requirements for API manufacturing. This training was designed to align with ICH Q1 and Q7 guidelines, emphasizing the importance of stability testing requirements in pharmaceutical registration and positioning the industry and regulators for excellence in API manufacturing and regulatory oversight.
In her opening remarks, the Director General of NAFDAC, Professor Mojisola Adeyeye, emphasized the critical need for harmonizing pharmaceutical stability guidelines across regions to ensure product stability throughout their lifecycle. She highlighted NAFDAC’s dedication to adhering to ICH guidelines, with the goal of achieving full ICH membership, integrating principles of stability, quality risk management, GMP, and bioequivalence into regulatory processes to strengthen Nigeria’s pharmaceutical landscape.
Overview of ICH Q1 and Q7 Guidelines:
ICH Q1: Stability Testing Guidelines:
- Focuses on stability testing of new drug substances and products to determine their shelf life and appropriate storage conditions.
- Key elements include stability study design, testing parameters, storage conditions, and establishing retest periods or expiry dates.
ICH Q7: Good Manufacturing Practice (GMP) for APIs:
- Offers a framework for quality assurance during the manufacturing of APIs.
- Encompasses quality management, personnel training, equipment handling, production processes, documentation, and quality control measures.
Key Outcomes and Action Plans:
- Participants gained an in-depth understanding of ICH Q1 and Q7 guidelines, recognizing their crucial role in maintaining drug quality, safety, and efficacy.
- Action plans were developed to reinforce regulatory processes, including enhancing stability data review, conducting regular GMP inspections, and effectively implementing ICH guidelines within national regulatory frameworks.
- A commitment was made to adopt and integrate the principles of ICH Q1 and Q7 into stability reviews, GMP inspections, and bioequivalence assessments, ensuring alignment with international best practices.
Conclusion
The workshop concluded with a shared commitment to adopting and adhering to ICH Q1 and Q7 guidelines, emphasizing the importance of stability in ensuring patient safety and product integrity. It underscored the value of collaboration and ongoing capacity-building to support medicine security and harmonization across Africa, aligning with the goals of the African Medicines Regulatory Harmonization Initiative.
Links and References:
NAFDAC Guidelines Reflecting ICH Q1 Implementation:
- NAFDAC GMP for Pharmaceutical Products Guidelines (2021): Stability requirements outlined in sections 8.55 to 8.80.
- Quality Guidelines for the Registration of Pharmaceuticals for Human Use: Sections 2.3.S7, 3.2.S.7, S7.1-S7.3, 2.3P.9
