GMP is an acronym for Good Manufacturing Practice regulations put in place by the U.S. Food and Drug Administration (FDA). GMP is typically used in facilities where drugs or medication are manufactured. These regulations address a variety of areas, including cleanliness, personnel qualifications and record-keeping, all in an attempt to ensure safety in the manufacture and care of FDA-regulated products by minimizing the chance of contamination or human error.
The first principle of GMP is to develop detailed step-by-step procedures, in writing, that provide a "road map" for consistency in performance. Written procedures allow for workplace standards to be clearly established, ensuring that a job or procedure is performed in the same way each time, with each step followed as set out in the written instructions.
The written procedures will only be effective if they are followed to the letter, so it is important that no short cuts or modifications be permitted. Any deviation from the written instructions may adversely affect consistency in product quality.
The third GMP principle calls for prompt and accurate documentation of work, thus allowing for compliance with regulations and the ability to trace any problems. Accurate records provide a way to evaluate what happened if there is ever a problem or complaint regarding a product. This record keeping also chronicles the precise steps taken relating to GMP regulations.
This GMP principle notes the importance of validating that all systems and processes are working as they are meant to. This is achieved through documentation and properly following the written procedures, thus ensuring that quality and consistency are carried out according to plan.
Facilities and Equipment
The fifth GMP principle outlines the importance of integrating productivity, product quality and employee safety into the design and construction of the company's facilities and equipment. This reinforces the goals of quality and consistency at all stages of the process.
Equipment and facilities must be properly maintained, with documented written records to back up any work done. This minimizes any safety concerns and avoids any potential issues relating to contamination and quality control.
Job competency must be clearly demonstrated by each employee relating to his job. GMP requires an employee to be completely competent in his role. However, the definition of competence may vary for different people, so it's important that clearly defined and developed job competencies are in place relating to each job.
The eighth GMP principle is to ensure a product is protected from contamination. The first step in achieving this is to make cleanliness in the workplace a daily habit. Since the degree of cleanliness needed depends on the type of product being manufactured, standards must be put in place to ensure the appropriate cleanliness guidelines are followed.
This principle involves building quality directly into products via the systematic control of components and processes relating to each product. Quality control includes such areas as manufacturing, packaging, labeling, distribution and marketing. By placing clearly defined controls over all these areas and keeping accurate, timely records, quality is built into all stages of production.
Finally, the only way to determine how well GMP is being implemented is to conduct planned periodic audits to assess the success of compliance with GMP regulations.