1. Production Department
Role:
Responsible for the manufacturing of pharmaceutical products according to approved procedures and specifications.
Key Responsibilities:
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Execute batch manufacturing as per Batch Manufacturing Records (BMR).
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Operate and maintain production equipment.
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Ensure compliance with cGMP (current Good Manufacturing Practices).
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Maintain documentation related to production activities.
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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:
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Perform in-process checks (weight variation, hardness, disintegration, etc.).
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Line clearance before the start of operations (ensuring cleanliness and absence of previous product).
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Monitor adherence to SOPs and BMRs.
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Record deviations and support investigations.
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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:
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Approve SOPs, BMRs, and change controls.
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Conduct audits (internal and external).
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Handle deviations, CAPA (Corrective and Preventive Actions), and OOS (Out of Specification) investigations.
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Review and approve batch records and analytical data.
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Release or reject batches for market distribution.
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Train staff on quality systems and compliance.
Interactions Between Departments
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Production performs the work.
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IPQA monitors and ensures quality during the work.
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QA ensures the overall system and final product meet compliance and quality standards.
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