• Production Department: Manufactures pharmaceutical products by following approved procedures and GMP (Good Manufacturing Practices).

• Packing Department: Packages finished products into appropriate containers with proper labeling and ensures packaging integrity.

• Quality Control (QC): Tests raw materials, in-process samples, and finished products to ensure they meet quality specifications.

• Quality Assurance (QA): Ensures compliance with regulatory standards, reviews batch records, handles documentation, and oversees audits and validation activities.

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.

Production, Packing, and Quality Control (QC) departments play crucial and distinct roles to ensure that medicines are manufactured safely, effectively, and in compliance with regulatory standards. Here's a summary of each:

1. Production Department

Main Role: To manufacture pharmaceutical products in accordance with approved processes and Good Manufacturing Practices (GMP).

Key Responsibilities:

• Weighing, blending, granulation, compression, coating, and encapsulation.

• Following batch manufacturing records (BMR).

• Equipment operation, cleaning, and maintenance.

• Ensuring adherence to GMP and SOPs.

• In-process checks (e.g., weight variation, hardness).

• Documentation and traceability of manufacturing processes.

2. Packing Department

Main Role: To package finished dosage forms (like tablets, capsules, syrups) safely and attractively while meeting regulatory and marketing requirements.

Key Responsibilities:

• Blister packing, strip packing, bottle filling, labeling, and carton packaging.

• Ensuring correct labeling (batch number, expiry date, etc.).

• Following batch packing records (BPR).

• Monitoring line clearance to avoid cross-contamination.

• Checking print quality and packaging integrity.

• Controlling packaging materials inventory.

3. Quality Control (QC) Department

Main Role: To test and verify the quality of raw materials, in-process materials, and finished products before release.

Key Responsibilities:

• Sampling and testing of raw materials, packaging materials, and finished products.

• Stability studies and impurity profiling.

• Environmental monitoring and microbiological testing (if applicable).

• Instrument calibration and validation (e.g., HPLC, UV, IR).

• Ensuring compliance with pharmacopeial standards.

• Documentation, reporting, and handling of out-of-specification (OOS) results.