Biopharmaceutical Information / GMP / Bioman / 2021.3.10
What is GMP
GMP stands for Good Manufacturing Practice. The Korean name is 'Pharmaceutical Manufacturing and Quality Control Standards'. In the word GMP here, the word practice translated as standard may not sound familiar. Therefore, in order to understand more easily, practice has the meaning of practice, not theory, so it is good to understand that it means the contents to be observed in 'practice', not theory in pharmaceutical manufacturing and quality control.
Need for GMP
GMP is necessary to ensure the quality of safe medicines for the correct manufacture and distribution of medicines that deal with human life. Medicines used to treat diseases or prolong life are directly related to human life.
Therefore, the state manages medicines according to the law. In the case of the United States, it is managed by the US Federal Food, Drug, and Cosmetics Act, and in Korea, it is managed by the Pharmaceutical Affairs Act. General industrial products can be repaired or replaced through recall when quality problems occur, whereas in the case of pharmaceuticals, when problems occur, even when human lives are threatened, GMP is It is an indispensable criterion for quality control.
Management Act and Regulations on Pharmaceuticals, Cosmetics,
Food and Industrial Products in Korea
medicine | cosmetics | food | industrial products |
KGMP | CGMP | HACCP | KS |
* KGMP stands for Korean Good Manufacturing Practice.
3 elements of KGMP
KGMP aims to achieve at least the following three elements. These are called the three elements of KGMP.
① Minimization of artificial errors (chaos, mistakes)
② Prevention of contamination (crossover, microorganisms, foreign substances) and quality change of medicines
③ Establishment of advanced quality assurance system
Let me explain in more detail
① Minimization of artificial errors (chaos, mistakes)
[Structure and facility aspects]
- The size of the workroom should be a size that does not interfere with work.
- Appropriate facilities required for pharmaceutical manufacturing must be installed.
- Depending on the type of work, it must be separated, partitioned or divided.
* Separation refers to a state in which the entrance and exit of air are not interfered with in a separate building and sufficiently separated & In the case of the same building, it is divided into separate places by walls, so that the entry and exit of workers and the entry and exit area of raw materials are separate and the air Refers to a state in which the air conditioner is installed separately and the air is completely blocked.
* A division refers to a certain area that is blocked off by walls, partitions, etc.
* Classification refers to the division of a certain place or object by a certain period of time, etc.
[Organizational and management aspects]
- Manufacturing management department and quality control department are independent and each has a person in charge.
- Prepare standard operating instructions (SOP) and comply with them.
- Double inspection of important processes.
- Display the product name, serial number, etc. on the machine being used for manufacturing.
- Organize and keep records.
- Thoroughly educate and train workers on work.
② Prevention of contamination (crossover, microorganisms, foreign substances) and quality change of medicines
[Structure and facility aspects]
- Facility to prevent air pollution by dust, dust, etc. must be equipped.
- Cross-contamination is prevented by the exclusive use of workrooms and the use of closed machines.
- The mechanical parts that come into contact with medicines are made of materials that do not change medicines.
- Make the floor, walls and ceiling of the workroom easy to clean or disinfect.
- The aseptic preparation workroom is an aseptic room.
[Organizational and management aspects]
- Cleaning of the working room and washing of machinery and equipment is carried out in accordance with the standard guidelines.
- Thorough hygiene education for workers.
- Thorough hygiene management to prevent product contamination by workers.
- Restrict access to the workroom by third parties other than workers.
③ Establishment of advanced quality assurance system
[Structure and facility aspects]
- Arrange workrooms and machinery according to the flow of the manufacturing process.
- The size of the test room is sufficient and it is equipped with test facilities capable of performing the necessary tests.
- Install manufacturing machines capable of managing manufacturing units.
[Organizational and management aspects]
- The quality control department has independent authority from the manufacturing control department.
- Regular inspection and maintenance of facilities, machines, instruments, etc.
- Validation is conducted for processes, etc.
- Work and maintain records to enable traceability of batches.
- We conduct process inspections for each manufacturing process.
- Regular self-inspection is conducted to ensure compliance with GMP.
- Regular quality evaluation is conducted to minimize quality defects.
- Collect complaint information and use it to improve manufacturing management and quality control.
Comments