MPCR in the pharmaceutical industry stands for Master Production and Control Record.
The Master Production and Control Record (MPCR) is a crucial document that contains all the necessary information for manufacturing a pharmaceutical product consistently and according to established standards. Think of it as the recipe and detailed instructions for creating a specific drug. This standardized recipe is critical for batch-to-batch consistency and adherence to regulatory requirements.
Here's a breakdown of what an MPCR typically includes:
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Product Information:
- Name of the product
- Name and codes of the Active Pharmaceutical Ingredient (API)
- Dosage form and strength
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Batch Formula:
- A complete list of all ingredients, including APIs and excipients, along with their quantities.
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Batch Details:
- Batch number or code
- Batch size
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Equipment and Location:
- Identification of the equipment to be used (e.g., specific mixers, reactors, filling machines).
- Line and location where the manufacturing process will take place.
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Manufacturing Instructions:
- Detailed, step-by-step instructions for each stage of the manufacturing process, including:
- Raw material dispensing
- Mixing and blending procedures
- Granulation (if applicable)
- Tablet compression or capsule filling (if applicable)
- Coating (if applicable)
- Packaging
- Detailed, step-by-step instructions for each stage of the manufacturing process, including:
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Quality Control Procedures:
- In-process controls (IPCs) to be performed at each stage of manufacturing.
- Acceptance criteria for each IPC.
- Sampling procedures.
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Packaging and Labeling Instructions:
- Specific instructions for packaging the finished product.
- Labeling requirements, including artwork and placement.
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Start and Finish Dates:
- Planned or actual start and finishing dates for processing and packaging.
The MPCR serves as a reference document for the creation of the Batch Production and Control Record (BPCR). The BPCR is the completed record that documents the actual manufacturing of a specific batch, and it must demonstrate adherence to the instructions outlined in the MPCR.
In essence, the MPCR ensures that every batch of a pharmaceutical product is manufactured consistently and according to established procedures, ultimately contributing to product quality, safety, and efficacy.
