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:
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Weighing, blending, granulation, compression, coating, and encapsulation.
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Following batch manufacturing records (BMR).
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Equipment operation, cleaning, and maintenance.
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Ensuring adherence to GMP and SOPs.
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In-process checks (e.g., weight variation, hardness).
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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:
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Blister packing, strip packing, bottle filling, labeling, and carton packaging.
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Ensuring correct labeling (batch number, expiry date, etc.).
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Following batch packing records (BPR).
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Monitoring line clearance to avoid cross-contamination.
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Checking print quality and packaging integrity.
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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:
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Sampling and testing of raw materials, packaging materials, and finished products.
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Stability studies and impurity profiling.
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Environmental monitoring and microbiological testing (if applicable).
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Instrument calibration and validation (e.g., HPLC, UV, IR).
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Ensuring compliance with pharmacopeial standards.
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Documentation, reporting, and handling of out-of-specification (OOS) results.
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