FDA cGMP Inspections

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Introduction to clinical supplies cGMP.

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FDA cGMP Inspections

  1. 1. Rajendra.Sadare Senior Software Engineer-Testing and Validation Arisglobal Software Pvt.Ltd
  2. 2. cGMPs for Clinical Supplies Key Issue for the pharmaceutical industry – cGMP compliance with Current Good Manufacturing Practices in a research environment.
  3. 3. Current areas of non compliance (1) – Training tracking and record-keeping – Managing changes made to product, process, test methods, documentation
  4. 4. Current areas of non compliance (2) – Process, equipment and method validation – Vendor and supplier qualifications
  5. 5. FDA Establishment (CTS) Inspections: (1) What the FDA looks for in an inspection of a Clinical Trial Supplies (CTS) facility: • Organization and Personnel qualifications • Organization charts and SOPs • Outside services and contractors • Process, procedures, frequency, scope of activities
  6. 6. FDA Establishment (CTS) Inspections: (2) What the FDA looks for in an inspection of a CTS facility: • Training Records • Quality Assurance Unit • Test material handling • Test material packaging/labeling (samples)
  7. 7. FDA Inspection Reports The FDA will send a report of the inspection to the facility which can have any one of the following actions: • NAI – (No Action Initiated) No objectionable conditions or practices were found during an inspection or the objectionable conditions found do not justify further regulatory action • VAI – (Voluntary Action Initiated) Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action • OAI – ( Official Action Initiated) Regulatory and/or administrative actions will be recommended
  8. 8. Examples of FDA Enforcement Activity If the FDA find non-compliance after an inspection they can respond in any one of the following ways: • Warning letters • Re-inspection • Withdrawal of approvals • Seizure of test articles • Prosecution under federal law
  9. 9. Thank You

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