GMP and Flint Group Quality Policy

1. Commitment to Quality

• The organization commits to manufacturing products that meet quality, safety, and efficacy requirements.

• Emphasis on regulatory compliance with local and international GMP regulations.

2. Personnel Responsibilities

• All employees are aware of the GMP principles.

• Roles and responsibilities for ensuring GMP compliance are clearly defined.

• Ongoing training and competence are ensured.

3. Documentation and Records

• Procedures (SOPs), batch records, and logs are maintained.

• Records are accurate, legible, contemporaneous, original, and attributable.

• Change control processes are implemented to manage updates to documentation.

4. Facility and Equipment

• Facilities are designed to prevent cross-contamination.

• Equipment is qualified, maintained, and calibrated.

• Cleaning validation and environmental monitoring are in place.

5. Raw Material and Supplier Management

• Only approved suppliers are used.

• Materials are tested and released by the Quality Control (QC) department.

• There is traceability from supplier to finished product.

6. Production Controls

• Manufacturing is performed using approved procedures.

• In-process checks are carried out.

• Deviations and non-conformances are investigated and documented.

7. Quality Control and Assurance

• QC tests raw materials, intermediates, and finished goods.

• The GMP team ensures systems are in place to maintain GMP compliance.

• Internal audits and regular GMP reviews are conducted.

8. Handling of Deviations, CAPA, and Complaints

• Deviations are recorded and investigated.

• Corrective and Preventive Actions (CAPA) are implemented using the 8D structure where possible.

• Product complaints are logged, investigated, and resolved.

9. Validation and Qualification

• Processes, cleaning, and equipment are validated.

• Qualification of systems follows IQ/OQ/PQ protocols (Installation, Operational, Performance Qualification).

10. Continuous Improvement

• GMP compliance is a continuous process.

• The organization promotes a culture of quality and accountability.