FDA guidance on process validation
The FDA guidance on process validation is an important document that offers guidelines on Process Validation (PV), a critical aspect of medical device and pharmaceutical manufacturing.
In November ’08, the FDA issued a draft guideline that revised the old guidelines on PV. The FDA guidance on process validation was now the standard that replaced the FDA guidance on process validation that was in force from 1987. FDA guidance on process validation underwent another revision in January 2011, which is now the current standard. It has altered the spirit of the earlier documents in a few ways.
January 2011 changes
- It now gives greater emphasis to use ICH Q 8, 9 and 10;
- The term ‘commercial manufacturing’ has come to replace the old word, ‘commercial production’. This means a significant change in the scope of the ICH.
- The January 2011 FDA guidance on process validation has also given a slightly different definition of PV and Stage 1 and Stage 2.
- The new FDA guidance on process validationdescribes PV as “The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
Why did the FDA change guidelines on PV?
The FDA guidance on process validation underwent changes because it was observed during its investigations that drugs of inferior quality were being marketed even though they were manufactured under less demanding processes, which were being passed off as “validated”.
Manufacturers need to ask these:
In essence, FDA guidance on process validation requires manufacturers to ask themselves these questions:
- Which scientific evidence I have used gives me the confidence that my process is capable of consistently and repeatedly delivering quality product?
- Can I show that my process works as intended?
- What are the ways by which I can know that my process has remained in control?
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