GMP is the optimal principle of production or (GMP) The standardist is used in the pharmaceutical, medical, healthcare and food industries and establishes optimal production conditions to ensure product quality and safety of employees and consumer health safety, as defined by the World Health Organization. (WHO) It is based on seventeen principles:
The purpose of compiling these rules Producers are guided to establish the minimum conditions for good production, its continuity and quality product production, and to ensure that manufactured products are produced and controlled in accordance with the appropriate standards for their use and meet the needs of consumers in terms of quality, safety and efficiency.. Having a certificate created good conditions (GMP Certificate) It indicates compliance with the provisions of this certificate by the holder of this certificate and, by its nature, assures the consumer of its quality.
They are control factors that focus on the whole production and quality control operation and not on a specific process.. GMP is a pillar of healthy product production that creates and maintains the right infrastructure for production, including machinery, environment, equipment, manpower, and so on.. In summary, the main requirements of the GMP are as follows:
- Definition of all production processes clearly, systematically, operationally and revised, so that the capacity and production capacity of the product is proven with quality and in accordance with the predicted specifications..
- Accreditation of sensitive and key stages of production processes and major changes in each process.
- Providing the following facilities and supplies:
Appropriate, skilled and trained personnel, adequate building and space, appropriate equipment and services, materials, containers and proper labels, proper storage and transportation, approved guidelines and instructions
- Develop guidelines and instructions, especially for the use of tools, sites, and facilities, clearly, operationally, in simple language and without ambiguity..
- Train operators in such a way that they are ready to perform the processes correctly.
- Preparing manual / machine records during production operations, so that it shows all the steps and requirements in accordance with the defined instructions and guidelines and the production of the product with quantitative and qualitative specifications is predicted..
- Any hazardous deviations must be recorded and reviewed.
- Maintaining documents and records of different stages of production, including complete and traceable records of comprehensive and accessible distribution of products with minimal occurrence of any defects in their quality.
- Existence of a system available to return the bulk product sold And partial
- Existence of a system for reviewing and handling complaints received about 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:
Production, sales, construction, equipment and devices, personnel, cleaning, raw material testing, production control, quality control department, packaging material testing, final product testing, documentation, samples, complaints handling, product recall
US Food and Drug Administration (FDA) In the year 1938 The first guideline developed good production conditions, and the World Health Organization (WHO) annually 1967 The initial edition of GMP was prepared and released based on this instruction. Relevant committees of the organization are currently monitoring the global version. Different countries of the world apply the principles of this guideline in their laws and regulations and localize it according to their local standards. Other organizations include ICH.,PIC/s,EU GMP,APIC&… named
In any country, the Food and Drug Administration (Or its equivalent) Or legal entities under the supervision of this organization are responsible for issuing, renewing and revoking GMP licenses.
