“To improve is to change; to be perfect is to change often.” – Winston Churchill
As leaders and supporting players in the pharmaceutical, biotechnology and medical device industries, we commonly recognize the need for FDA guidance, as well as updating guidance documents to support the changing regulatory landscape. In practice, following the guidance can seem like an expensive game of darts.
Recently, the FDA reissued a draft guidance document on Analytical Procedures and Methods Validation for Drugs and Biologics, February 2014. This revised draft supersedes the August 2000 similarly titled draft guidance. The previous mammoth 33 page guidance gave detailed recommendations that differentiated INDs from NDAs and associated applications, going so far as to highlight requirements for methods using specific instrumentation.
The new and improved version offers a more streamlined understanding of method validation and the specific role within in the life cycle of a regulated product. Instead of detailing separate and potentially conflicting recommendations, the FDA has opted for referencing the appropriate technical body, including the USP, ICH and ASTM. The guidance even removes strict requirements for INDs in the Introduction stating: “This revised draft guidance does not address investigational new drug application (IND) methods validation, but sponsors preparing INDs should consider the recommendations in this guidance.” The author(s) instead reference several guidance documents currently published that address specific IND related documents.
For further information and access to the revised draft guidance, please visit the FDA website or access directly at the link below:
As we like to say while preparing samples in the laboratory, Keep Calm and Shake On!
- Guidance for Industry – Analytical Procedures and Methods Validation for Drugs and Biologics, February 2014, 14 page guidance including references