Batch Manufacturing Records

SOPs, environmental conditions and controls, and personnel common to batch manufacturing sites are used and where no changes are made to the manufacturing batch records except for administrative information and location of the facility. 

Scope of audit—Identify all areas assessed, such as batch records and manufacturing processes and areas. 

Documentation and recordkeeping of a separate master record with original signatures from the QA or QC departments to indicate their approval should be maintained. A master batch record should not be used as a batch record even if only one batch is to be produced from the master batch record. All manufacturing conditions and equipment usage should be recorded. This information is considered critical to support the proposed scale-up manufacturing process. Investigation reports should be available to address all production problems or... 

Recipe/formulation management Batch manufacturing instruction and records In-process testing Yield calculation Purified water Aseptic filling... 

Case Study 10 Electronic Batch Recording Systems (Manufacturing Execution Systems)... 

Records of manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form. 

Out-of-limit results (e.g. action limit deviations) should be recorded and form part of the batch manufacturing records. 

Batch manufacturing records (verification against master documents)... 

This firm uses the LIFO method, where the goods sold are evaluated at the cost of the last batch manufactured, or 1 per liter. So the credit side of the Finished goods account shows a withdrawal of 1,000 liters at 1 per liter. The debit side of the Cost of goods sold" account records the 1,000 cost of the 1,000 liters. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records, test records and manufacturing procedures. Reaction vessels and associated equipment must be calibrated, validated and cleaned to acceptable levels before being used this is especially the case for multi-product plants where more than one API is manufactured. 

A batch manufacturing record should be completed during the production of each batch of intermediate products and of active pharmaceutical ingredients. It should contain the relevant parts of the master formula and should include the following ... 

A batch manufacturing record should be completed during the production of each batch of intermediate products and of active... 

Batch manufacturing records should be retained for at least two years after completion of the clinical trial or at least two years after formal discontinuation or in conformance with the applicable regulatory requirement(s). 

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