SOP on Batch Production & Control Records
1.0 Purpose: This SOP defines information to be recorded in batch production and control records.
2.0 Scope: This SOP applies to Production Chemist and operating staff.
3.0 Responsibility: Production Chemist to ensure that procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: Batch production and control records are prepared for each batch of drug product produced and it includes complete information relating to production and control of each batch –
5.1.0. An accurate reproduction of appropriate master production or control record, checked for accuracy, dated and signed.
5.2.0 Documentation that each significant step in the manufacture, processing, packing or holding of batch is accomplished, includes –
5.2.1 Dates.
5.2.2 Identity of individual major equipment used.
5.2.3 Specific identification of each batch of component or in-process materials used.
5.2.4 Weights and measures of components used in the course of processing.
5.2.5 In-process and laboratory control results.
5.2.6 Inspection of packaging and labeling area before and after use.
5.2.7 A statement of actual yield and statement of percentage of theoretical yield at appropriate phases of processing.
5.2.8 Complete labeling control records, including specimens or copies of all labeling used
5.2.9 Description of drug product containers and closures.
5.2.10 Any sampling performed.
5.2.11 Identification of persons performing and directly supervising or checking each significant step in the operation.
5.2.12 Any production record review.
5.2.13 Results of examinations made in accordance with on line inspections.