GMP (Good Manufacturing Practices) is a systematic approach that ensures that the production carried out at a plant is carried out continuously according to certain quality standards and that production processes are controlled. If a production contains risks that cannot be eliminated only by testing the final product, the risks at all stages of production can be minimized with the GMP approach. Enterprises and facilities that meet the requirements of this system with certain rules and criteria can prove their ability to produce well by obtaining a GMP certificate.
GMP covers all aspects of production, from raw materials, plants and equipment to the training and personal hygiene of personnel. In order for a production to have a valid GMP Certificate, it must have written and detailed procedures for any process that will affect the quality of the final product. However, evidence should also be documented to show that these procedures are followed literally and in all aspects.
Good manufacturing practice guidelines provide guidance for production, testing and quality assurance in order to ensure that a food or pharmaceutical product is safe for human consumption. Manufacturers of food, drug and medical devices operating in many countries declare that they follow GMP procedures and comply with their legislation; within this framework, they create their own GMP rules.
In order for a production to qualify as GMP and be eligible for a GMP certificate, it must comply with the following basic principles:
1. There should not be the slightest problem with cleanliness and hygiene in the environments where the drug is produced.
2. Controlled environmental conditions should be ensured in which any negative ingredients that may make food or pharmaceutical products unsafe for human consumption are removed.
3. Production processes should be clearly defined and explained in all their details. In particular, approvals should be obtained indicating that the critical production steps comply with the required technical requirements.
4. Production processes should be constantly checked and the observed changes should be evaluated. In particular, changes that have an impact on the quality of the final product must be verified.
5. All instructions and procedures must be written clearly and clearly.
6. Operators should be provided with the necessary training to carry out and document the procedures.
7. During production, records should be made manually or with appropriate measuring equipment, indicating that all the steps necessary for the defined procedures and instructions have actually been carried out; that the quantity and quality of food or medicine is as expected. If a deviation or inaccuracy is detected, its causes should be investigated and reported.
8. Records of all processes and history of products, including distribution, should be stored in an understandable and accessible way.
9. A suitable systematic structure should be in place within GMP to retrieve any batch of products from sale or from the procurement process.
10. Complaints about marketed products should be examined, the causes of quality defects should be investigated, and appropriate measures should be taken to prevent recurrence of defective products.
Scope and Advantages of GMP Certificate
The GMP certificate is not a certification process that specifies compliance with the rules and instructions on how to manufacture products. GMP certificate can be issued to productions whose compliance with certain principles that need to be followed (as mentioned above) has been proven. When establishing a company´s quality program and production process, it can implement various systems to meet GMP requirements and obtain a GMP certificate if it declares this compliance. It is the responsibility of the company to determine the most effective and efficient quality process created for the purpose of obtaining a GMP certificate.
The GMP certificate basically provides the following benefits:
-The management capabilities of the relevant organization in terms of product quality and safety assurance are proven
-It is ensured that every employee who manages production or personally participates in production acquires a good production and operation habit.
-Risks to product quality and safety are minimized.
-One of the most important benefits provided by the GMP Certificate to the enterprise where it is located is undoubtedly the reduction of costs by detecting problems in a timely manner.
-The GMP Certificate helps to better understand and comply with the laws and regulations related to production.
-In addition to the marginal benefits provided by many companies, they also want to obtain a GMP certificate in order to gain respect and reliability at both the national and international levels.
-Customers always have more confidence in businesses that are sensitive to GMP and have the necessary documents.
-It is useful for organizations that want to obtain a GMP Certificate to work with a consulting firm and receive the necessary training before applying for a certificate in this regard. Because it is impossible to obtain a document within the enterprise without fulfilling the processes related to GMP and providing the necessary documentation. GMP consulting and training firms are able to provide sustainable support to businesses in this regard.