Good Manufacturing Practices for Pharmaceutical Products (GMP)

Good Manufacturing Practices for Pharmaceutical Products (GMP)

2.1 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 authorization. GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers. Under GMP:

(a) all manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications;

(b) qualification and validation are performed;

(c) all necessary resources are provided, including:

        (i) appropriately qualified and trained personnel;

        (ii) adequate premises and space;

        (iii) suitable equipment and services;

        (iv) appropriate materials, containers and labels;

        (v) approved procedures and instructions;

        (vi) suitable storage and transport;

        (vii) adequate personnel, laboratories and equipment for inprocess controls;

(d) instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided;

(e) operators are trained to carry out procedures correctly;

(f)     records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; any significant deviations are fully recorded and investigated;

(g) records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and acces-sible form;

(h) the proper storage and distribution of the products minimizes any risk to their quality;

(i) a system is available to recall any batch of product from sale or supply;

(j) complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence.