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The process validation is derived from the fact that the specific exercise of process validation should never be designed to fail. Failure in carrying out the process validation assignment is often the result of incomplete or faulty understanding of the process’s capability, in other words, what the process can and cannot do under a given set of operational circumstances. In a well-designed, well-run overall validation program, most of the budget dollars should be spent on equipment, component,facility, methods qualification, and process demonstration, formerly called process qualification. 

Table 2 The Key Stages in the Product/Process Development Sequence

Development stage Pilot scale-up phase
Product design

Product characterization

Product selection (“go” formula)

Process design

    1 × batch size
Product optimization

Process characterization

Process optimization

      10 × batch size
Process demonstration Process validation program

Product/process certification

     100 × batch size


With the exception of solution products, the bulk of the work is normally carried out at 10 × batch size, which is usually the first scale-up batches in production-type equipment.

The U.S. FDA’s preapproval inspection program , wherein the applicant firm under either a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) submission must show the necessary CGMP information and qualification data (including appropriate development reports), together with the formal protocol for the forthcoming full-scale, formal process validation runs required prior to product launch.

 the term validation has both a specific meaning and a general one,depending on whether the word “process” is used. the entire concept is discussed  with the topic—i.e., design, characterization, optimization, qualification, validation, and/or re validation.

Source & Reference-Drug and Pharmaceuticals sciences (Volume 129)

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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