GMP

Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products, and medical devices.
According to FDA, GMP is defined as the sanitary & processing requirements of food companies. They are broad and general and used as a guide for the development of SOPs which are very specific. GMPs belong in every food quality control system. The Code of Federal Regulations provides excellent definitions &criteria which determine if the product has been manufactured under conditions which make it unfit for food;or if the product has been processed under insanitary conditions resulting in contamination with filth;or is otherwise rendered injurious to health. Since sampling product will statistically only ensure that the samples themselves are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important part of GMP is documentation of every aspect of the process, activities, and operations involved with drug and medical device manufacture. If the documentation showing how the product was made and tested is not correct and in order, then the product does not meet the required specification and is considered contaminated
Additionally, GMP requires that all manufacturing and testing equipment has been qualified as suitable for use, and that all operational methodologies and procedures utilized in the drug manufacturing process have been validated (according to predetermined specifications), to demonstrate that they can perform their purported functions.
Other 'Good Practice' systems, along the same lines as GMP, exist:Good Laboratory Practice (GLP)for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals); Good Clinical Practice' (GCP)for hospitals and clinicians conducting clinical studies on new drugs in humans; Good Regulatory Practice (GRP) for the management of regulatory commitments, procedures and documentation.
CFR contains detailed requirements for avoiding these possibilities in the following areas:
n PERSONNEL
n PLANT AND GROUNDS
n SANITARY OPERATIONS
n SANITARY FACILITIES AND CONTROLS
n EQUIPMENT AND UTENSILS
n PROCESSES AND CONTROLS
n MANUFACTURING OPERATIONS
n WARE HOUSING AND DISTRIBUTION
PERSONNEL
n Disease control
n Cleanliness
n Education and training
n Supervision
PLANT AND GROUNDS
n Proper equipment storage
n Maintenance of surrounding property
n Effective systems for waste disposal
n Space for equipment placement and storage of materials
n Seperation of operations likely to cause contamination
n Sanitation precautions for outside fermentation vessels
n Building construction to permit adequate cleaning,adequate lighting,ventilation and screening.
SANITARY OPERATIONS
n BUILDING AND FIXTURES
Maintenance,cleaning and sanitizing to prevent contamination.Special precautions for toxic sanitizing agents
n PEST CONTROL
n FOOD CONTACT SURFACES:Sanitary procedures.
SANITARY FACILITIES AND CONTROLS
n Water supply
n Plumbing
n Sewage disposal
n Toilet facilities
n Handwashing facilities
n Rubbish and offal disposal
EQUIPMENT AND UTENSILS
n Design,materials and workmanship shall be cleanable
n Protected against contamination
n Non toxic
n Seamless
n Properly maintained
PROCESSES AND CONTROLS
n Adequate sanitation in receiving
inspection,transporting,segregating,
manufacturing,packaging and storing
n Appropriate quality control operations to ensure that food is suitable for human consumption and that packaging operations are unsafe and suitable
n Chemical, microbial and extraneous material testing
n Rejection of adulterated or contaminated material.
RAW MATERIALS
n Shall be inspected for suitability for processing into food.
n Stored to minimize deterioration
n Wash and conveying water to be adequate
sanitary quality
n Containers shall be processed for possible contamination or deterioration of food.
n Microorganisms presence shall not be at a level which might produce food poisoning ,and shall be pasteurized during manufacturing to maintain a safe level.
n Levels of toxins (like aflatoxins),or presence of pest contamination or extraneous material to be in compliance with FDA regulations
n Storage of raw materials,ingredients or rework shall be protected against contamination &held at a temperature and humidity which will prevent adulteration
n Frozen raw materials shall be thawed only as required prior to use and protected from adulteration.
MANUFACTURING OPERATIONS
n Equipment,utensils and finished food containers to be sanitized as necessary
n Manufacturing,packaging and storage to be controlled for minimum contamination
n Growth of undesirable organisms shall be prevented by refrigeration,freezing,sterilising,irradiating,water activity control..
n Protection against inclusion of metals or other extraneous materials shall be effective
n Adulterated food,ingredients or raw materials shall segregated and if reconditioned,shall be proven to be effectively free from adulteraion
n Mechanical manufacturing steps such as peeling,trimming,washing,cutting,cooling,inspectingetc shall be performed without contamination
n Preparation of batters,breading,sauces,gravies,dressings and similar preparations shall be prepared without contamination by effective means.
n Compliance may be accomplished by a quality control operation in which CCPs are identified and controlled during operation;all food contact surfaces are cleaned and sanitized;all materials used are safe and suitable;physical protection from contamination.
WAREHOUSING AND DISTRIBUTION
n Storage and transportation of finished foods shall be protected against physical,chemical and microbial contamination as well as deterioration of the food and the container
CONCLUSION
It shall be noted that the FDA regulations for GMP is modified from time to time and it is necessary to review quality control proceduresto ensure compliance