Explain process validation of coated tablets.
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BASIC CONCEPT OF PROCESS VALIDATION IN SOLID DOSAGE FORM (TABLET): Process validation is an essential component for the safety of drug product and also to maintain the quality of the product. Process validation is the fundamental component for assuring the quality system used by pharmaceutical industries.
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Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process validation is a requirement of current Good Manufacturing Practices.
the process validation activity can be described in three stages:-
process design
process qualification
continued process verification
TYPES OF PROCESS VALIDATION:-
A) Prospective validation (or premarket validation)
B) Retrospective validation
C) Concurrent validation
D) Revalidation
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