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The document is a Batch Manufacturing Record for Tongkat Ali Tablets, detailing the production process, raw materials, equipment used, and quality assurance procedures. It includes sections on product details, area clearance, production procedures, yield calculations, and post-production reviews to ensure compliance with Good Manufacturing Practices (GMP). The record is prepared by the Production Manager and approved by the QA Manager.

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Which department is responsible to complete the batch records?

Batch records: These documents are typically used and completed by the manufacturing department.

How do you prepare your BMR?

What should be included in a batch manufacturing record? Start and end dates of the manufacturing process. All materials and components used, including the amounts of each one. Step-by-step documentation of the entire manufacturing process, from start to finish \u2014 including dates of completion for each step.

Who is responsible for batch manufacturing record?

The head of the Quality Control Department then has the responsibility "to evaluate batch records" (2.6ii) as well. This means that before a batch record gets to the QP, it has been evaluated at least twice.

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What should be in a batch record?

The batch record contains precise information on how exactly the product was made, which standard operating procedures (SOPs) were followed, which critical quality attributes (CQAs) are assessed and which critical process parameters (CPPs) were used.

How do you create a BMR?

1. Batch Record: A very first page of the BMR has all records about the batch as batch number, batch size, composition, master formula record referred the weight of the batch, shelf life, storage conditions, manufacturing license number, manufacturing date, expiry date, date of starting and date of completion. 2.

What is a manufacturing record?

Manufacturing Records means all documents relating to the Manufacture of a Batch, including manufacturing instructions, deviations, test results, out of specification results, investigations, bills of materials and certificates of analysis.

Who is responsible for batch manufacturing record?

What is a batch record?

What is a batch record? A Batch Record is a document that provides the complete manufacturing history of a pharmaceutical product. It aims to assure the safety and quality of the manufactured product by: Providing processing instructions to the operator during the execution of a manufacturing processes.

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