Good Manufacturing Practice

Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation or product specification.

Good Manufacturing Practice is concerned with both production and quality control.

The basic requirements of GMP are that:

  1. all manufacturing processes are clearly defined, systematically reviewed in the light of experience and shown to be capable of consistently manufacturing medicinal products of the required quality and complying with their specifications
  2. critical steps of manufacturing processes and significant changes to the process are validated
  3. all necessary facilities for GMP are provided including:
    1. appropriately qualified and trained personnel
    2. adequate premises and space
    3. suitable equipment and services
    4. correct materials, containers and labels
    5. approved procedures and instructions
    6. suitable storage and transport
  4. instructions and procedures are written in an instructional form in clear and unambiguous language, specifically applicable to the facilities provided
  5. operators are trained to carry out procedures correctly
  6. records are made, manually and/or by recording instruments, during manufacture which demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected. Any significant deviations are fully recorded and investigated
  7. records of manufacture including distribution which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form
  8. the distribution (wholesaling) of the products minimises any risk to their quality
  9. a system is available to recall any batch of product, from sale or supply
  10. complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.