SOP on Master Packaging Records
SOP on Master Packaging Records
1.0 Purpose: The purpose of this document is to laid down requirements for packaging records in manufacture of a drug batch.
2.0 Scope: This SOP applies to Production Staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: Master packaging records are prepared for each product. The information in master packaging records includes –
1. Name of product.
2. Description of product’s pharmaceuticals form and strength.
3. Batch size.
4. Complete list of pack, sizes expressed in appropriate unit and with types of all packaging materials associated with them.
5. Copy of relevant printed packaging materials (e.g. labels,foils, cartons)
6. Special precautions to be observed (e.g. room temperature, relative humidity).
7. Permissible limits of packaging loss / gain for reconciliation of total packaged yield Vs actual manufacturing yield.
Master Formula Record (MFR) in Pharmaceuticals: FAQ
1. What is a Master Formula Record (MFR)?
A Master Formula Record (MFR) is a comprehensive document used in the pharmaceutical industry that contains the complete instructions and specifications necessary to produce a batch of a specific drug product. It serves as the official reference for the manufacturing process, ensuring consistency, quality, and compliance with regulatory standards.
2. Why is the MFR important in pharmaceutical manufacturing?
The MFR is crucial because it ensures that each batch of a product is manufactured consistently, with the same quality, strength, and purity. It also helps in maintaining compliance with Good Manufacturing Practices (GMP) and regulatory requirements, providing a detailed reference for audits and inspections.
3. What information is typically included in an MFR?
An MFR typically includes:
- Product name and description
- List of raw materials with their quantities
- Detailed manufacturing instructions
- Packaging and labeling instructions
- In-process controls and tests
- Equipment required for manufacturing
- Specifications for quality control tests
- Storage and handling requirements
- Approval signatures from authorized personnel
4. Who is responsible for preparing the MFR?
The MFR is usually prepared by the product development team or the technical department within the pharmaceutical company. It is then reviewed and approved by the Quality Assurance (QA) department before being implemented in the manufacturing process.
5. How does the MFR ensure product consistency?
The MFR ensures consistency by providing a standardized set of instructions that must be followed for every batch of the product. This reduces the risk of errors and variations in the manufacturing process, leading to consistent product quality.
6. What is the difference between an MFR and a Batch Manufacturing Record (BMR)?
The MFR is a master document that outlines the general process and specifications for manufacturing a product, while the Batch Manufacturing Record (BMR) is a specific document used for recording the details of each individual batch produced according to the MFR. The BMR serves as a log that verifies that the batch was made following the MFR’s instructions.
7. How often should the MFR be reviewed or updated?
The MFR should be reviewed periodically, usually annually, or whenever there is a significant change in the manufacturing process, raw materials, or regulations. Any updates must be documented, reviewed, and approved by the QA department.
8. What role does the MFR play in regulatory compliance?
The MFR plays a key role in regulatory compliance by providing a documented procedure for the manufacturing process. It ensures that the product is produced according to GMP standards, which is essential for passing regulatory inspections and audits.
9. Can the MFR be used in legal or regulatory audits?
Yes, the MFR is often reviewed during legal or regulatory audits to verify that the manufacturing process is controlled and consistent. It serves as evidence that the company is following GMP and producing products that meet regulatory standards.
10. What happens if a discrepancy is found in the MFR during production?
If a discrepancy is found in the MFR during production, the manufacturing process should be halted, and the issue should be reported to the QA department. An investigation will be conducted to determine the cause of the discrepancy, and corrective actions will be taken before production can resume.
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