What is GMP or good production conditions?
GMP stands for Good Manufacturing Practice as the main foundation of safety and health systems and includes a set of requirements and instructions that describe the methods, equipment required, facilities and controls required to produce quality products in the following areas: Give:
- Medicinal products for humans and veterinary use
- Biological products
- Products made from natural sources such as humans, animals or microorganisms
- Medical Equipment
- Processed food
The purpose of developing these criteria is to guide producers to establish the minimum conditions of good production, its continuation and production of a quality product, and to ensure that the products produced are produced and controlled in accordance with the appropriate standards for their application and meet the needs of consumers in terms of quality. Satisfy safety and efficiency. Having a GMP Certificate indicates that the holder of this certificate has complied with its provisions and by its nature gives the consumer confidence in its quality.
What does GMP control?
GMP principles are control factors that focus on the entire production operation and quality control and not on a specific process. GMP is a pillar of healthy product production that creates and maintains suitable infrastructure for production, including machinery, environment, equipment, manpower, etc. In summary, the main requirements of the GMP Rules of Procedure are as follows:
- Definition of all production processes is clearly, systematically, operationally and revised, so that the product capacity and production capacity is proven with quality and in accordance with the expected specifications.
- Validation of sensitive and key stages of production processes and major changes in each process.
- Availability of the following facilities and supplies: Appropriate, skilled and trained personnel, adequate building and space, appropriate equipment and services, proper materials, containers and labels, proper storage and transportation, approved guidelines and instructions
- Develop guidelines and instructions, especially for the use of tools, tools and facilities, clearly, operationally, in simple language and without ambiguity.
- Train operators to be prepared to perform the processes correctly.
- Preparation of manual / machine records during the production operation, in a way that shows that all steps and requirements are performed in accordance with the defined instructions and guidelines, and the production of the product with quantitative and qualitative specifications is foreseen.
- Any hazardous deviations 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 the least occurrence of any problems in their quality.
- Existence of an available system for returning bulk and partial sold products
- Existence of a system for reviewing and handling complaints received about manufactured products, investigating the cause of quality defects, taking corrective measures and preventing their recurrence
In short, the parts of a production unit that are subject to GMP rules are: sales production, building, equipment and devices, personnel, cleaning, raw material testing, production control, quality control department, packaging material testing, testing Final product, documentation, samples, complaint handling, product recall
What is the GMP definition reference and do its terms change over time?
The US Food and Drug Administration (FDA) developed the first Good Manufacturing Guidelines in 1938, and the World Health Organization (WHO) developed the original GMP in 1967 based on these guidelines. Relevant committees of this organization are currently overseeing the editing of the global version. Different countries of the world apply the principles of this guideline in their laws and regulations and localize them according to their local standards. Other organizations include ICH, PIC / s, EU GMP, APIC &...
Are the GMP conditions different in different countries? The generalities are the same because they are taken from the World Health Organization and the organization oversees the editing of the international GMP, but different countries change these principles to some extent according to their domestic laws, regulations and standards.
What organization issues GMP? In each country, the Food and Drug Administration (or equivalent) or legal entities under the supervision of this organization are responsible for issuing, renewing and revoking this license.
Is the GMP valid for a certain period of time and can a manufacturer's GMP certification be revoked after its issuance? Yes. In general, depending on the policies of each government, these certificates have a limited validity for a certain period of time. In addition, the responsible institutions can suspend or revoke the issued license in case of violation of the laws and regulations discussed in this certificate.