1. Production Department

Role:
Responsible for the manufacturing of pharmaceutical products according to approved procedures and specifications.

Key Responsibilities:

• Execute batch manufacturing as per Batch Manufacturing Records (BMR).

• Operate and maintain production equipment.

• Ensure compliance with cGMP (current Good Manufacturing Practices).

• Maintain documentation related to production activities.

• Train operators and ensure a safe working environment.

2. IPQA (In-Process Quality Assurance)

Role:
Acts as a bridge between Production and QA, ensuring real-time quality checks during manufacturing processes.

Key Responsibilities:

• Perform in-process checks (weight variation, hardness, disintegration, etc.).

• Line clearance before the start of operations (ensuring cleanliness and absence of previous product).

• Monitor adherence to SOPs and BMRs.

• Record deviations and support investigations.

• Ensure data integrity during manufacturing.

Objective:
To catch and correct issues before the final QA review and product release.

3. Quality Assurance (QA) Department

Role:
Oversees the entire quality system and ensures the final product meets regulatory and internal standards.

Key Responsibilities:

• Approve SOPs, BMRs, and change controls.

• Conduct audits (internal and external).

• Handle deviations, CAPA (Corrective and Preventive Actions), and OOS (Out of Specification) investigations.

• Review and approve batch records and analytical data.

• Release or reject batches for market distribution.

• Train staff on quality systems and compliance.

Interactions Between Departments

• Production performs the work.

• IPQA monitors and ensures quality during the work.

• QA ensures the overall system and final product meet compliance and quality standards.