• 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”...
    Read more ...