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The term GMP has a legal status – it is codified in Food and Drug Administration (FDA) Current Good Manufacturing Practice (cGMP) Regulations for foods including a general regulation covering all foods and specific regulations for specific food categories. It is very clear that these are wholly concerned with hygiene requirements for food safety. GMP is the concern and responsibility of every kind of manager in industry. It is evident that GMP has two complementary, and interacting components; the manufacturing operations themselves, and a quality control/quality assurance system. Both of these components must be well designed and effectively implemented.
Every aspect of the manufacturing operation must be properly specified in advance and systematically reviewed regularly, including all resources and facilities, premises and space, equipment, trained people, raw materials, packaging materials, storage, transport, operating procedures, cleaning procedures, establishment of critical control points, management and supervision, and services.
To ensure that manufacturing operations go according to plan it is essential that:
The other and complementary major component of GMP is effective food control. Effectiveness requires:
All production and food control personnel should be trained in the principles of GMP, in all relevant aspects of food hygiene and in the practice and under lying principles of the tasks assigned to them. Similarly, all other personnel whose duties take them into manufacturing areas or bear on manufacturing activities, should receive appropriate training. Records should be kept of the training of each individual.
Effective documentation is an essential and integral part of GMP and, in particular, one of the essential features of a properly operated HACCP system. The purposes of documentation are to define the policies, materials, operations, activities, control measures and products; to record and communicate information needed before, during or after manufacture; to reduce the risk of error arising from oral communication; and to form a vital part of the audit trail necessary for tracing the history of the components used to produce the final product. The system of documentation should ensure that, as far as is practicable, the history of each batch of product, including utilisation and disposal of raw materials, intermediates and bulk or finished products, can be ascertained.
Buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them and to facilitate the protection of materials and products from deterioration, contamination or cross-contamination.
Equipment should be designed, constructed, adapted, located and maintained to suit the processes and products for which it is used; to facilitate protection of the materials handled or the resulting products from contamination, cross-contamination or deterioration; and to facilitate effective cleaning.
Products and processes should be so designed as to ensure that the end-product meets consumer expectation within the intended and anticipated duration and circumstances of use, and to ensure that product design and performance have been fully evaluated for the required function in respect of microbiological safety, chemical safety, physical safety and sensory quality.
All raw materials should be stored under hygienic conditions, and in specific conditions indicated in their specifications, and having regard to any regulatory requirements for storage of hazardous raw materials.
Each packaging material should comply with its specification. The specification should be such as to ensure that:
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