Thực hành tốt sản xuất thuốc (GMP) & ĐÁNH GIÁ GMP

Good Manufacturing Practices (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production.

GMP Audit refers to regular visits to evaluate facilities, production and ensure that all activities are in line with current good manufacturing practices (cGMP).

Quality Management (QM) is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use.

COURSE AGENDA

1 Introduction to GMP & GMP AUDITS

2 General Information about GMP Audits

3 Quality System

3.1. Good Manufacturing Practices (GMPs)

3.2. Basic Requirements of Good Manufacturing Practices (GMPs)

3.3. Pharmaceutical Quality System

4 Personnel

4.1. Personnel

4.2. Personnel & Hygiene

5 Premises & Equipments

5.1. General Information about Premises & Equipments

5.2. Premises & Equipments Requirements in Manufacturing Area

5.3. Premises & Equipments Requirements in Storage Area

5.4. Premises & Equipments Requirements in Quality Control

5.5. Equipment

6 Documentation

6.1. General Information about Documentation

6.2. Specification

6.3. Manufacturing Documentation

7 Production

7.1. General Information about Production

7.2. Contamination, Cross Contamination, Mix-up

7.3. Cross-Contamination

8 Quality Control

8.1. General Information

8.2. Good Laboratory Practices

9 Quality Assurance

9.1. Product Quality Review (PQR)

9.2. Complaints

9.3. Change Management

9.4. Deviation

9.5. Corrective Action & Preventive Action

10 Additional Audit Questionare

11 Conclusion