Similarities
1) cover a wide range of products, including RX drugs, OTCs, biologics, & medical devices. Regulations apply to all stages of manufacturing, from raw material sourcing to the final packaging and distribution.
2) require manufacturers to provide adequate training to their employees.
3) prescribe certain standards for facility design and maintenance to ensure the integrity of pharmaceutical production environments.
4) mandate batch release procedures and quality control testing before products can be released for distribution.
5) In both regions, non-compliance with GMPs can result in penalties, including product recalls, warning letters, fines, and even criminal charges in severe cases.
Differences
1) EU GMPs have a more risk-based approach, where manufacturers are expected to identify and control potential risks throughout the production process. In contrast, US GMPs have a more prescriptive approach, with specific requirements for each step of the manufacturing process.
2) EU GMPs require that these laboratories are independent from the production areas, while US GMPs allow for them to be located within the production facility.
3) EU GMPs have stricter requirements for environmental monitoring, while US GMPs focus more on product testing.
4) National authorities are responsible for conducting inspections for EU, while the USFDA conducts inspections.
5) EU GMPs place a greater emphasis on this by requiring manufacturers to have a systematic approach to identify, assess, and control risks associated with manufacturing processes. On the other hand, the US GMPs also prioritize risk management but offer more flexibility in implementing risk-based approaches.
6) EU GMPs tend to have more detailed requirements for documentation and record keeping. They provide specific guidance on the content and format of documents such as SOPs & batch records. US GMPs, provide more general expectations for documentation but may not offer as much specific guidance.
7) EU GMPs require a formal process validation protocol for critical manufacturing processes, with predefined acceptance criteria. In comparison, the US GMPs emphasize the use of a science-and risk-based approach to process validation but do not specifically mandate a formal protocol.
8) EU GMPs go a step further by requiring manufacturers to have a PQS to ensure the consistent quality of products and covers all aspects of the manufacturing process, from design and development to distribution and post-market surveillance. US GMPs do not explicitly mention a PQS but do require companies to have a comprehensive qms in place.
9) EU is currently in the process of implementing new GMP guidelines EU GMP Annex 1, which focuses on sterile medicinal products. USFDA is also working on updating its GMP regulations to align with the changing landscape of the pharmaceutical industry.
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Resource Person: Bharathi Kodali