1. Master Batch Record (MBR)
This is a comprehensive document that provides detailed instructions for the manufacturing of a specific product. It includes information on raw materials, equipment, processing steps, and quality control tests.
2. Batch Manufacturing Record (BMR)
This record is created for each batch of a product manufactured.
3. Batch Packaging Record (BPR)
This record is specific to the packaging process of a product. It includes information on the packaging materials used, labeling instructions, packaging line setup details, and any quality control tests performed during packaging.
4. Cleaning Batch Record (CBR)
This record documents the cleaning procedures followed after each batch production to ensure that equipment and facilities are properly cleaned and free from any #contamination or cross-contamination risks.
5. Validation Batch Record (VBR)
This record is created during the validation process of a manufacturing or packaging process. It includes information on the validation protocol followed, test results obtained, and any adjustments made to the process based on validation findings.
6. Stability Batch Record (SBR)
This record is created for stability testing purposes to assess the shelf life and storage conditions of a product over time. It includes information on sample collection dates, storage conditions, testing methods used, and test results obtained at various time points.
7. Investigational New Drug (IND) Batch Record
This record is specific to clinical trials conducted during drug development stages. It includes information on the formulation used in clinical trials, dosing instructions for patients/participants, adverse event reporting procedures, and any modifications made during the trial period.
8. Process Development Batch Record
This record documents the development phase of a new manufacturing process or formulation. It includes information on experimental batches produced with varying parameters or ingredients to optimize the final product's quality and efficiency.
9. Analytical Batch Record (ABR)
This record is created during the analysis of a batch to ensure its compliance with quality standards. It includes information on the analytical methods used, test results obtained, and any corrective actions taken if the batch fails to meet specifications.
10. Investigational Medicinal Product Dossier (IMPD) Batch Record
This record is specific to clinical trials conducted in Europe. It includes information on the formulation used in clinical trials, dosing instructions for patients/participants, adverse event reporting procedures, and any modifications made during the trial period, as required by European regulatory authorities.
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