What is Current Good Manufacturing Practices (cGMP)?

cGMP is the aspect of QA that ensures the consistent production and control of products to meet pre-determined quality standards. The primary aim of cGMP is to reduce two inherent risks involved in pharmaceutical production – mix-ups and cross-contamination. Mix-up refers to the confusion caused by the interchange of materials, whereas cross-contamination is the unexpected contamination of one batch of product by another product.

cGMP guidelines are prescribed by every country’s drug regulatory authority and according to WHO, cGMP requires that:

(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:

• Appropriately qualified and trained personnel;

• Adequate premises and space;

• Suitable equipment and services;

• Appropriate materials, containers, and labels;

• Approved procedures and instructions;

• Suitable storage and transport;

• Adequate personnel, laboratories, and equipment for in-process 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 accessible 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 are investigated, and appropriate measures are taken for the defective products to prevent recurrence.