Drug product quality was seen as the function of the status of the product itself.

Flawed approach- destructive tests-individual products can not be tested.

No statistical method was available to ensure quality of a batch of drug.

US FDA included some form of validation around mid 1970s (Process validation 21 CFR parts  210 and 211)

Initially limited to sterile products and later extended to other dosage forms

This was out of a concern to develop a verification mechanism that would need to be applied to the process to be meaningfully extrapolated to an entire batch

In the Indian scene this emerged as a requirement for those firms who wished to register with foreign agencies.

Followed by those requiring WHO GMP Certification for COPP.

Now included in the revised schedule M

what is it Calibration?

A set of operations that establish, under specified conditions, the relationship between values indicated by an instrument or system for measuring, recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard. limits of acceptance of the results of measuring should be established.

for more details please download PPT file........


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