|
Quality Relationships
 Quality Management
ß
Quality Assurance
ß
 GMP
ß
Quality Control
ROLE/SCOPE
Principles of QA
- Totality of the arrangements
- to ensure that device is of right Quality for the
intended use
Principles of QA
QA
incorporates
GMP
and also
product design & development
Requirements for QA
Systems
1. Ensure products are developed correctly
2. Identify managerial responsibilities
3. Provide SOPs for production & control
4. Organize supply and use of correct starting materials
5. Define controls for all stages of manufacture and
packaging
6. Ensure finished product correctly processed & checked
before release
7. Ensure products are released after review by authorized
person
8. Provide storage & distribution
9. Organize self-inspection |
Functions of QA
- Regulatory related
- Customer related
- Standards Related
- Approvals/Certification related
- Operations related
REGULATORY RELATED
- Site Master File
- GMP Check List
- Updating on regulations
- Collect Reference Standards & Books
- Supervise Recall, Rejection, Disposal
- Attend Inspection, Compliance
- Report
- Review of Non-conforming Report
- Corrective & Preventive Actions
- Recall Procedure
CUSTOMER RELATED
- Contract Review
- Customer Complaints & Failure
- Investigation
APPROVALS/CERTIFICATION RELATED
- Develop Quality Management System
- Act as Management Representative
- QA Proc., SOP, Guidance, Formats
- Documentation
- Document Distribution System
- Document Change Control
- Attend Technical Consultants
- Validation & Qualification Protocol
- Stability Protocol
STANDARDS RELATED
- Specifications
- Quality Plans, Sampling Plan
- Vendor Selection & Assessment
OPERATIONS RELATED
- Training Programme
- On-job Training
- Batch Release
- Environment Monitoring Guidelines
- Labeling of RM/Product for hold
- Material Review Board meeting
- Deviation Control
- Self Inspection
|
