Written procedures are the corner stone of any GMP manufacturing facility. Procedures are written to ensure each employee is doing the same thing so that you end up with the same result. This is true whether you work in the laboratory, the production floor, maintenance, or quality.
The Code of Federal Regulations (21 CFR 211.100 written procedures; deviations), states that there should be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality and purity that they purport or are represented to possess. Procedures must be written, reviewed, and approved. Once approved, procedures must be followed and documented at the time of performance. Any changes to the procedures must also be reviewed and approved before execution. Any deviation from the written procedure must be documented and justified.
A company recently received the following observation:
….. Written production and process control procedures are not followed in the execution of production and process control functions.
Specifically, the firm’s written procedure SOP…, “Machine Maintenance Program” is not fully followed. The procedure states, “Scheduled Maintenance is performed in accordance with the manufacturer’s recommended schedule.” During a review of the … equipment maintenance log, it was observed that the firm uses maintenance intervals … dependent on the piece of … equipment. A review of the Manufacturer’s Manual lists certain maintenance activities to be conducted once a day, every other day, and once a week that do not match any maintenance checklist citing a maintenance interval of … utilized by the firm. The firm could not produce records showing completion of these maintenance items cited in the manufacturer’s manual in the timeline specified.
For more information on implementing production and process controls, refer to the FDA Presentation, Production and Process Controls: Overview of cGMP Regulations and Regulatory Expectations.
To view more observations pertaining to production and process controls, refer to the following GMP Trends® Issues: 1110, 1103, 1089, and 1084,
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