GMP is an abbreviation of GOOD MANUFACTURING PRACTICE, which means "good manufacturing practice" in Chinese. The World Health Organization defines them as regulations that guide the production and quality control of food, drugs and medical products.

The GMP standard was officially published by the World Health Organization in November 1975. GMP certification is a practice necessary to comply with guidelines recommended by the agency that controls the authorization and licensing of the manufacture and sale of cosmetics, pharmaceuticals, dietary supplements, and medical devices, which provide minimum requirements that manufacturers must meet to ensure that their products are always of high quality, from batch to batch, for their intended use. The rules governing each industry can vary greatly; However, the primary purpose of GMP has always been to prevent harm to end users. Other principles include ensuring that the final product is not contaminated, that its production is consistent, that its manufacturing work is well documented, that personnel are well trained, and that product quality checks are not just the end stage. GMP is usually ensured through the effective use of quality management systems (QMS). Good Manufacturing Practice (GMP) is a system for ensuring that products are always manufactured and controlled in accordance with quality standards. It aims to minimize the risks involved in the production of any pharmaceutical product that cannot be eliminated by testing the final product.

Basic overview of GMP certification

Scope of GMP certification

GMP covers all aspects of production from starting materials, premises and equipment to employee training and personal hygiene. Detailed written procedures are essential for every process that may affect the quality of the finished product. Systems must be in place to provide documented proof that correct procedures have been followed throughout each step of the manufacturing process - every time a product is manufactured.

Principles followed by GMP guidelines

All guides follow some basic principles:

The manufacturing plant must maintain a clean and hygienic manufacturing area.

Manufacturing facilities must maintain controlled environmental conditions to prevent cross-contamination of dopants and allergens, which could make the product unsafe for human consumption or use.

Manufacturing processes must be clearly defined and controlled. Verify all key processes to ensure consistency and compliance with specifications.

The manufacturing process must be controlled and any changes to the process must be evaluated. Verify changes affecting the quality of the drug if necessary.

Instructions and programs must be written in clear and unambiguous language using good documentation practices.

Operators must be trained to perform and record procedures.

Manual or electronic records must be made during the manufacturing process to demonstrate that in fact all steps required by the defined procedures and instructions have been taken and that the quantity and quality of the food or drug is as expected. Deviations must be investigated and documented.

Manufacturing records (including distribution) that trace the complete history of the lot must be maintained in a form that is easily understood and accessible.

Any product distribution must minimize its quality risk.

There must be a system in place to recall any lot sold or supplied.

Complaints about marketed products must be checked, the causes of quality defects must be investigated, and appropriate measures must be taken against the defective products to prevent their recurrence.

Good manufacturing practices are recommended to safeguard the health of consumers and patients and to produce quality products. In the United States, food or drug products can be considered "adulterated" if they have passed all specification tests but are found to be manufactured in facilities or conditions that violate or do not meet current good manufacturing guidelines.

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a set of general principles that must be followed in the manufacturing process. When companies develop quality plans and manufacturing processes, there may be many ways to meet GMP requirements. It is the responsibility of the company to determine the most efficient and efficient quality processes to meet business and regulatory needs.

GMP certification cycle

As one of the types of medical device quality management system, GMP is one of the basic conditions for enterprises applying for certification. Enterprises must establish and run the system for 3-6 months to provide the organization with the resources, capabilities and records to operate the GMP system. Therefore, it takes 3-6 months from establishment to application for GMP certification.

Benefits of GMP certification

1. Prevent the mixing of different drugs or their ingredients;

2. Prevent cross-contamination caused by other drugs or other substances; Prevent error and measurement transfer and information transfer distortion;

3. Prevent the occurrence of accidents that omit any inspection steps;

4. Prevent illegal accidents such as arbitrary operation, non-implementation of standards and low feeding limits;

5. The main purpose of formulation and implementation of GMP is to protect the interests of consumers and ensure the safety and effectiveness of drug use; At the same time, it is to protect drug manufacturers, so that enterprises have laws to follow and rules to follow. In addition, the implementation of GMP is the responsibility entrusted by the government and the law to the pharmaceutical industry, and it is also the need of the implementation of the drug quality assurance system after China's accession to the WTO.