23 April & 21 May 2017 Discussion Forum

1. Discussion Forum on ICH Q7 & Q11
Approaches of Implementation
Dr. Obaid Ali
Deputy Director, DRAP
Member ISPE, PDA
23 April 2017 (Program A)
21 May 2017 (Program B)

2. Approaches of Implementation
Q7 Q11

3. Good Manufacturing Practices
Quality
Management
Principle Responsibilities of the Quality Unit
Responsibilities of the Production Activities
Internal Audit (Self Inspection)
Product Quality Review

4. Good Manufacturing Practices
Personnel
Qualification
ConsultantsHygiene

5. Good Manufacturing Practices
Building
&
Facilities
Design &
Construction
Utilities Water
Containment Lighting
Sewage &
Refuse
Sanitation &
Maintenance

6. Good Manufacturing Practices
Process
Equipment
Design &
Construction
Maintenance Cleaning
Calibration Computerization

7. Good Manufacturing Practices
Documentation
& Records
System &
specifications
Cleaning &
Use Record
RM, IM, API
Labeling
Packaging
Master
Production
Instructions
Batch
Production
Records
Lab Control
Records
Reviews

8. Good Manufacturing Practices
Material
Management
Controls Receipt & Quarantine
Sampling & Testing of Incoming Materials
Storage
Re-evaluation

9. Good Manufacturing Practices
Production &
In-process
Controls
Operation Time limits
Sampling &
Controls
Blending
batches of API
& IM
Contamination
Control

10. Good Manufacturing Practices
Packaging &
Labeling
General
Packaging
Materials
Label
Issuance &
Control
Packaging &
Labeling
Operation

11. Good Manufacturing Practices
Storage &
Distribution
Storage Procedure
Distribution Procedure

12. Good Manufacturing Practices
Laboratory
Controls
Controls Testing Validation
COA Stability
Expiry &
Retest
Retention
Samples

13. Good Manufacturing Practices
Validation
Policy Documentation Qualification
Approaches to
PV
PV Program
Periodical
Review
Cleaning
Validation
Analytical
Method
Validation

14. Good Manufacturing Practices
Change
Control

15. Good Manufacturing Practices
Rejection &
Re-use
Rejection first Reprocessing Reworking Recovery Returns

16. Good Manufacturing Practices
Complaints
& Recall
Contract
Manufacturing
Contract
Laboratories

17. Good Manufacturing Practices
Agents, Brokers,
Traders, Distributors,
Re-packers & Re-labelers