Highly regulated industries, such as pharmaceutical and biotech manufacturing, face a myriad of compliance issues, which vary by region of the world and continuously involve.
Emerson’s Heather Schwalje presented Regulatory Drivers- GMPs 21st Century to Life Science manufacturers in India and Bangladesh. Her presentation covered a good manufacturing practice (GMP) overview, GMP for computerized systems, and GMP strategies. We’ll cover the GMP overview in today’s post.
The objective of GMP was to provide a regulatory compliance overview for the manufacturing and business processes to simplify the compliance approach.
Regulatory bodies like the U.S. Food and Drug Administration (FDA) are aggressively monitoring the industry manufacturing practices across globe and imposing heavy fines for any compliance avoidance.
Current Good Manufacturing Practice (cGMP) is intended to make the same product, the same way—every time AND be able to prove it. Non-compliance has internal organizational consequences and external consequences. Internally, non-compliance impacts direct costs, “continual crises” costs, and remediation costs. Externally these manufacturers may face regulatory action costs, market share costs, and reputational costs.
Heather highlighted the FDA’s 21 CFR Part 210 introduction of drug attributes around safety, identity, strength, purity, and quality (SISPQ). Failure to comply renders product to be considered “adulterated” and may result in regulatory action for the product as well as individuals responsible.
21 CFR Part 211 is divided into 11 subparts to cover all aspects of manufacturing as well as general considerations and scope. These include resource management—organization & personnel, buildings & facilities, equipment, control of materials and components; manufacturing execution—production process & controls, packaging & labeling control, records & reports; and supporting processes—holding & distribution, laboratory controls, returned & salvaged drug products.
On August 21, 2002, the FDA announced a major new initiative on the regulation of drug product quality signaling a philosophical transition from reactive to proactive quality management. It is based on five principles:
- Ensure regulatory review and inspection policies based on state-of-the-art pharmaceutical science
- Encourage the adoption of new technological advances by the pharmaceutical industry.
- Integrate advances in quality management techniques, including quality systems approaches
- Integrate risk-based approaches, that focus both industry and agency attention on critical areas
- Enhance the consistency and coordination of Agency drug quality regulatory programs
Heather next addressed aspects of the European Union’s Eudralex Volume 4, which includes basic requirements for medicinal products, for active substances, and GMP-related documents. It also addresses computerized systems, qualification and validation.
In an effort to harmonize the various global regulations, the International Conference on Harmonization (ICH) was established back in 1990 and it included the European Union, Japan and United States. Its goal was to reduce duplication during R&D of new drugs while safeguarding quality, safety and efficacy. Also, it sought to develop guidance documents addressing technical and regulatory requirements for new drug applications.
ICH Q10 addresses Q7: Good Manufacturing Practice, Q8: Pharmaceutical Development (Quality by Design, QbD), Q9: Quality Risk Management, and Q10: Pharmaceutical Quality System.
From the FDA’s Q10 Pharmaceutical Quality System draft guidance document:
ICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable to manufacturing sites is currently specified by regional GMP requirements.