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Batch records: These documents are typically used and completed by the manufacturing department.
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.
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.
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.
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.
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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.
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.
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.
Batch manufacturing record is a written document from the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step. There are several stages of the pharmaceutical product manufacturing process.
QA/Production shall be responsible for the review of filled Batch Manufacturing Record (BMR) as well as Batch Packing Record (BPR) as per Annexure-3 and Annexure-4.

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