April 2, 2019

SOP For Corrective Action and Preventive Actions

SOP For Corrective Action and Preventive Actions   OBJECTIVE: Lay down the procedure for corrective and preventive action programme in executing and documenting activities’ for continued compliance and improvement in process as per cGMP. SCOPE: This SOP is applicable to the procedure for Corrective Action and Preventative Actions (CAPA) program at manufacturing facility… RESPONSIBILITY: Officer […]

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Performance Qualification (PQ) Protocol & Report Format In Pharmaceuticals.

Performance Qualification In Pharmaceutical Industry. Systems and equipment should consistently perform in accordance with design specifications. The performance should be verified in accordance with a performance qualification protocol. There should be documented records for the verification of performance (performance qualification report) to indicate the satisfactory performance over a period of time. Manufacturers should justify the

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