Key Principles of GMP include:
1. Creation and enforcement of Standard Operating Procedures (SOPs).
2. Comprehensive documentation of all procedures and processes.
3. Validation of SOP effectiveness.
4. Development and implementation of efficient working systems.
5. Development of employee competencies.
6. Regular maintenance of systems, equipment, and facilities.
7. Prioritizing cleanliness to prevent contamination.
8. Ensuring quality is central to the design, development, and manufacturing workflow.
GMP
Basic Requirements of EU-GMP encompass:
1. Clearly defined manufacturing processes, systematically reviewed, and demonstrated to consistently produce medicinal products meeting quality requirements and specifications.
2. Validation of all critical manufacturing process steps and significant process changes.
3. Adequately qualified and trained personnel.
4. Sufficient premises and space.
5. Appropriate equipment and services.
6. Correct materials, containers, and labels.
7. Approved procedures and instructions in accordance with the Pharmaceutical Quality System.
8. Proper storage and transportation.
9. Written instructions and procedures in clear, facility-specific language.
10. Operator training to ensure accurate procedure execution.
11. Maintenance of records by operators, manually or through recording instruments, verifying adherence to defined procedures and the expected product quantity and quality.
12. Comprehensive recording and investigation of significant deviations, followed by corrective and preventive actions.
13. Retention of production and distribution records in an accessible format for complete batch traceability.
14. Distribution practices that minimize product quality risks, adhering to Good Distribution Practices.
15. Implementation of a product recall system.
16. Examination of product complaints, investigation of quality defect causes, and actions taken to prevent future defects.