Batch production records

Batch Production Records (Batch Production and Control Records)... 

The weight or measure is correct as stated in the batch production records ... 

Master Production Instructions Batch Production Records Laboratory Control Records Batch Production Record Review Materials Management General Controls Receipt and Quarantine... 

ABC Pharmaceutical Industries information. Weighing of a lot follows detailed step-by-step instructions as outlined in the batch production record. Weighing of all ingredient materials is accomplished in a dedicated room within the class 100 air quality. The preweighed ingredients are transported to the mixing/compounding area. 

The equipment sterilization charts are included in the batch production record. The equipment sterilization charts for stability batch are produced in support of this submission. These sterilization charts shall be reviewed by Quality Assurance for adherence to the sterilization cycles specified in the batch records. 

Documentation and records (systems, specifications, raw materials, intermediates, labeling, packaging materials, master production and batch records, laboratory control records, batch production record review)... 

Batch production records are correct and suitably signed off. 

In the United States, drug GMPs were formally introduced in 1963 and included the regulation of computer systems. 21 CFR Part 211.2(b) emphasized computer backups and documentation, including keeping hardcopy of master formulas, specifications, test records, master production and control records, batch production records (batch production and control records), and calculations. 

What outputs, such as batch production records, are sent to other parts of the network ... 

The Reproduction of the Batch Production Record from the Master Production Record... 

It is now time for the actual batch production record (per 21 CFR Section 211.188) to be reproduced from the master production record. The batch production record will mimic the master in every aspect, from the batch quantity and expected yields to the QC tests needed and the provision for delineating any deviations during production. SeeTable 1 for details of development. 

The assigned lot number for the batch must be required by the MPR and included on every page of the batch production record. 

Execution of the validation protocol. Define critical parameters. Critical parameters of the process can be defined as those steps that play an essential role in the successful manufacture of the product. Define these parameters and clearly state them in the master production record and batch production record. 

Working with the batch production record. Training. Production and QA personnel should be trained to the batch production record. 

No master for that particular batch production record... 

Batch production records are a reproduction of the master production record. All batch records must have a corresponding master production record. 

Procedures (SOPs) Master/batch production records Labeling Purchasing... 

List of all applicable reports supporting manufacturing process development (e.g., process validation protocols and reports, cleaning validation, protocols and reports, and batch production records). 

Standard operationg procedures (SOPs) incomplete, not current, or not available to the operators in the production area Batch production records incomplete, not recorded at time of operation, or not specific enough to document significant process steps Cleaning procedures not validated or not including all processing equipment and transfer implements (scoops, etc.)... 

Printing devices used to print labels for packaging operations should be controlled to ensure that all imprinting conforms to the print specified in the batch production record. 

Packaging and labeling facilities should be inspected immediately before use to ensure that all materials not needed for the next packaging operation have been removed. This examination should be documented in the batch production records, the facility log, or other documentation system. 

Final batch production record Laboratory tests... 

Filling in data by workers turns the master production record into the batch production record. 

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