Tag: CAPA

How to Organize the Quality Agreement for Drug Products Manufacturing

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A quality agreement is a crucial document that defines the responsibilities and expectations of the parties involved in the manufacturing of pharmaceutical products. The quality agreement helps in ensuring that the product is produced in compliance with the regulatory requirements and also meets the quality standards. One of the essential aspects of the quality agreement is Read more about How to Organize the Quality Agreement for Drug Products Manufacturing[…]

FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices

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FDA inspection is one of the critical elements of FDA’s role in ensuring high quality products are comings to market which does not pose a threat to public. To ensure it FDA inspects various drug and device manufacturing facilities and reviews the systems and processes time to time. These are various regulations and guidance documents Read more about FDA Inspectors’ Inspection Checklist & Method of Compliance for CAPA Inspection – Med Devices[…]

Pre Approval Inspection and things to look for

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Following are the key things you should look for pre approval inspection. Deviations, OOS, product failures Investigations and CAPA’s Label control QA oversight Management oversight Drug Safety and Pharmacovigilance projects Process, shipping cleaning method Vendor and contractor qualification and oversight Deviations gives the indication of break down in one or all of the following:Equipment, processes, SOP’s, Read more about Pre Approval Inspection and things to look for[…]

Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)

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see that corrective action taken to correct existing product nonconformity or quality problems and Prevent recurrence of the problem The corrective action should Include explanations for how the firm will meet the requirements for all elements of the CAPA subsystem Gain working knowledge of the firm’s CAPA procedure before beginning evaluation of this subsystem Have Read more about Pointers Inspectors look for during FDA inspection – For CAPA (QSIT)[…]