GMP

GMP

What is GMP or Good Manufacturing Practice?

GMP stands for Good Manufacturing Practice as the main basis of safety and health systems, including a set of requirements and instructions that describe the methods, required equipment, facilities and controls required to produce quality products.

WHO defines good manufacturing practice (GMP) as follows: ‘Part of the quality assurance that ensures that products are constantly producing and controlled.

GMP defines quality criteria for manufacturing and quality control, as well as 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 and not on a specific process. GMP is the pillar of healthy product production, which deals with the creation and maintenance of suitable infrastructures for production, including machines, environment, equipment, manpower, etc.

the main requirements of GMP procedures are as follows:

– Definition of all production processes clearly, systematically, operationally and revised, so that the capacity and ability to produce the product with quality and in accordance with the expected specifications has 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, in a way that shows the completion of all steps and requirements in accordance with 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 comprehensive and accessible distribution of products with minimal occurrence of any problems in their quality.

– Existence of an available system for returning wholesale and partial 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, and in 1967, the World Health Organization (WHO) prepared and released the first edition of GMP based on these guidelines. Related committees of this organization are currently overseeing the editing of its global version. Different countries of the world 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, but 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 violation of the laws and regulations discussed in this certificate.

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