• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
FDA cGMP Inspections
 

FDA cGMP Inspections

on

  • 3,426 views

Introduction to clinical supplies cGMP.

Introduction to clinical supplies cGMP.

Statistics

Views

Total Views
3,426
Views on SlideShare
3,407
Embed Views
19

Actions

Likes
2
Downloads
0
Comments
0

2 Embeds 19

http://www.slideshare.net 14
http://www.linkedin.com 5

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    FDA cGMP Inspections FDA cGMP Inspections Presentation Transcript

    • Rajendra.Sadare Senior Software Engineer-Testing and Validation Arisglobal Software Pvt.Ltd
    • cGMPs for Clinical Supplies Key Issue for the pharmaceutical industry – cGMP compliance with Current Good Manufacturing Practices in a research environment.
    • Current areas of non compliance (1) – Training tracking and record-keeping – Managing changes made to product, process, test methods, documentation
    • Current areas of non compliance (2) – Process, equipment and method validation – Vendor and supplier qualifications
    • 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
    • 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)
    • 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
    • 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
    • Thank You