WHO defines good manufacturing practice (GMP) as ‘Part of the quality assurance that ensures that products are constantly produced and controlled.
GMP defines quality criteria for manufacturing and quality control and general measures to ensure that the processes necessary for manufacturing and testing are clearly defined, validated, reviewed, and documented and that personnel, locations, and materials are appropriate for the production of pharmaceuticals and biologicals, including vaccines.
GMP also has legal components that cover distribution responsibilities, contract manufacturing and testing, and response to product defects and complaints.

GMP principles are control factors that focus on the entire production and quality control process, not a specific process. GMP is the pillar of healthy product production, which deals with creating and maintaining suitable infrastructures for production, including machines, environment, equipment, staffing, etc.

The main requirements of GMP procedures are as follows:

– Definition of all production processes, systematically, operationally, and revised so that the capacity and ability to produce the product with quality and following the expected specifications have been proven.

– Validation of sensitive and key stages of production processes and major changes in each process. 

– Availability of the following necessary facilities and supplies: 

•  Suitable, skilled, and trained personnel
•  Sufficient building and space
•  Appropriate equipment and services
•  Correct materials, containers, and labels
•  Proper storage and transportation
•  Approved guides and instructions

– Preparing guides and instructions, especially for using tools and facilities, clearly, operationally, in simple and unambiguous language.

– Training the operators in such a way that they are ready to perform the processes correctly. 

– Preparation of manual/machine records during the production process to show the completion of all steps and requirements following the defined instructions and guides and the production of the product with the expected quantitative and qualitative specifications.

– Every dangerous deviation must be recorded and investigated.

– Maintaining documents and records of various stages of production, including complete and traceable records of the comprehensive and accessible distribution of products with minimal occurrence of any problems in their quality. 

– Existence of an available system for returning wholesale and partially sold products 

– Existence of a system for investigating and dealing with complaints received about the sold products, investigating the cause of quality defects, taking corrective measures, and preventing their recurrence.

In short, parts of a production unit that are subject to GMP rules are:

– Sales production

– building

– Equipment and devices

– personnel

– cleaning

– Tests of raw materials

– production control

– Quality control department

– Testing of packaging materials

– Final product tests

– documentation

– sample

– Handling complaints

– Product recall 

In 1938, the United States Food and Drug Administration (FDA) developed the first guidelines for good manufacturing conditions. In 1967, the World Health Organization (WHO) prepared and released the first edition of GMP based on these guidelines. Related committees of this organization oversee the editing of its global version. Different countries apply the principles of this directive in their laws and regulations and localize them according to their local standards. Other organizations include ICH, PIC/s, EU GMP, APIC, etc.

Its general principles are the same because they are taken from the World Organization WHO, and this organization supervises the editing of international GMP. Still, different countries change these principles according to their internal laws, regulations, and standards.

In any country, the Food and Drug Organization (or its equivalent) or legal entities under the supervision of this organization are responsible for issuing, renewing, and revoking this license.

Yes. In general, depending on the policies of each government, these certificates have limited validity for a certain period of time. In addition, the responsible institutions can suspend or cancel the issued license in case of violating the laws and regulations discussed in this certificate.