Introduction to clinical supplies cGMP.

1. Rajendra.Sadare
Senior Software Engineer-Testing and
Validation
Arisglobal Software Pvt.Ltd

2. cGMPs for Clinical
Supplies
Key Issue for the pharmaceutical
industry –
cGMP
compliance with
Current Good Manufacturing Practices
in a research environment.

3. Current areas of non
compliance (1)
– Training tracking and record-keeping
– Managing changes made to product,
process, test methods, documentation

4. Current areas of non
compliance (2)
– Process, equipment and method
validation
– Vendor and supplier qualifications

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. 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. 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. 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. Thank You