It came to a surprise to me that some pharma manufacturers, especially OTC, are still not aware of the needs to conduct process validation... Our DCA has made this compulsory for product registration in stages since last year.
Being not aware is one problem.... Being ignorant is worse..! Manufacturer's should take effort to equip their personnel with the required knowledge and skills. Process validation is not only meeting GMP requirements and ensuring your GMP license remain valid. It is much more than that.
With validated process, you can rest assure that you have good control and your process, and able to consistently produced output that meets the quality criteria you have pre-determined. You will have peace of mind.
In a world where patients are now knowledgable and more demanding, this is one aspect of GMP you cannot do away with...!
AJ.
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