The cGMP regulations are designed to ensure that products meet safety, efficacy, purity, and stability standards. Compliance with cGMP regulations is verified by reviewing a company's documented adherence. Because random regulatory inspections of commercial laboratories can be conducted anytime—without prior notification—experts suggest that all commercial laboratories conduct routine comprehensive cGMP self-evaluations.
This article identifies key components of a laboratory control system and discusses current cGMP practices and challenges.The Laboratory Facility
Facility personnel designate cGMP areas on the building's floor plans. To carry out all cGMP operations consistently, facilities must be of adequate size and design; the general condition of the airflow, temperature, and humidity systems must be monitored to ensure that all laboratory operations are carried out in a controlled environment. Work areas must be kept clean and uncluttered, cleanliness maintained and assessed continuously. Separation of test articles must be maintained to ensure that the samples are not exposed to contamination or stress, and prevented from mixing or handling errors.2
Maintenance and operation should be based on standard operating procedures (SOPs) or operating manuals. Equipment logs, a vital source of information to demonstrate overall compliance, are maintained to document adherence to SOPs, calibrations, and to report adverse events. All equipment must be categorized by cGMP status and by cGMP critical or noncritical use. Equipment with critical status requires preventive maintenance and calibration and must undergo full qualification and validation. Other categories of equipment may require qualification or validation, based on the specific equipment use. Automatic, mechanical, and electronic equipment all require validation.
All laboratory processes, including facilities, equipment, analytical methods, and computer programs used in the analytical testing of pharmaceutical products must be validated.2 Following an initial evaluation, every supplier is audited and qualified. Validation includes several different qualification activities: a validation master plan outlines the overall approach to be taken for validation. User requirement specifications (URS) and functional requirement specifications (FRS) are defined for design qualification (DQ) or for subsequent validation testing. URS specifies the users' needs, as well as any regulatory requirements. FRS are statements that specify what the system must be able to do to meet the users' needs. These act as key reference points of validation.