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What is `good manufacturing practice’ (GMP) in relation to food?

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.

Effective manufacturing operations and food control:

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:

  • Relevant written procedures are provided to operators, in instructional form and in clear and unambiguous language, and are specifically applicable to the facilities provided;
  • Operators are trained to carry out the procedures correctly;
  • Records are made (whether manually or by recording instruments or both) during all stages of manufacture, which demonstrate that all the steps required by the defined procedures were in fact carried out, and that the quantity and quality produced were those expected;
  • A traceability system is in place to identify and track all inputs into, and outputs from, the manufacturing process;
  • Records are made and retained in legible and accessible form to enable the history of the manufacture and distribution of a batch to be traced;

Effective food control:

The other and complementary major component of GMP is effective food control. Effectiveness requires:

  • Well-qualified and appropriately experienced food control management participating in the drawing up of specifications;
  • Adequate staff and facilities to do all the relevant monitoring of suppliers, inspection, sampling and testing of materials, and monitoring of process conditions and relevant aspects of the production environment (including all aspects of hygiene);
  • Rapid feedback of information (accompanied where necessary by advice) to manufacturing personnel, thereby enabling prompt adjustment or corrective action to be taken, and enabling processed material either to be passed as fit for further processing or for sale as the case may be, or to be segregated for decision as to appropriate treatment or disposal.

Personnel and training:

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.

Documentation:

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.

Premises, equipment, product and process design:

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.

Ingredients and packaging materials:

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:

  • The product is adequately protected during its expected life under normally expected conditions
  • In the instance of packaging coming into immediate contact with the product, there is no significant adverse interaction between product and packaging material;
  • Where the packaged product undergoes subsequent treatment, whether by the manufacturer, caterer or consumer, the packaging will adequately stand up to the processing conditions and no adverse packaging/product interaction occurs;
  • The packaging is capable of providing the necessary characteristics and integrity where the preservation of the product depends on the pack;
  • The finished pack will carry the statutory and other specified information in the required form and location.

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