Manufacturing

C&Q in Process Validation - Where Does It Fit In?

4 days ago   |   By PSC Biotech

This is the fourth installment in PSC's series on Quality Risk Management in Commissioning and Qualification. This follows on the concepts introduced in the first three installments: QRM in C&Q Planning , Risk Assessments - One Size Does Not Fit All , and Critical Aspects of Pharmaceutical Facilities and Equipment - Identification and Verification. This week's article discusses where C&Q activities fit into the process validation lifecycle.
Background
Validation of pharmaceutical manufacturing processes became a cGMP expectation in the early 1980s. For many years afterward, “Validation”...
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