GMP is the World Health Organization (WHO), the specific requirements of the quality management system of all pharmaceutical companies, drugs must be produced in accordance with GMP regulations, so what are the three major objectives of the implementation of GMP?
GMP's three main objectives
The objective elements of GMP implementation are to minimize human errors, prevent contamination of pharmaceutical products, and ensure a quality management system for high-quality products.
1. Minimize human error.
1) In terms of management, for example, the quality management department is independent from the production management department; Establish a system of mutual supervision and inspection; designate the responsible persons of each department; Formulate standardized implementation rules and operating procedures: strict review of each production process, such as weighing, material storage and requisition, etc.; In each production process, to a transport container, the main machinery used for the production. It is necessary to indicate the name, specification, batch number and other status marks of the drug being produced; Organize and keep records (generally 1 year after the expiration date of the product, and 3 years for drugs without a specified expiration date); Staffing, education and management.
2) In terms of equipment, for example, each workshop should be kept spacious to eliminate obstacles to production; Different varieties of operations must have a certain spacing, strictly separated.
2. Prevent contamination and quality reduction of drugs.
1) In terms of management, for example, the standards and implementation of cleaning and equipment cleaning in the operation room; Strict hygiene education for production personnel; Operators conduct regular physical examinations to prevent production personnel from contaminating drugs with germs and viruses; Restricting non-production personnel from entering the workplace, etc.
2) In terms of equipment, for example, to prevent dust pollution to drugs, there must be corresponding mechanical equipment (air conditioning purification system, etc.); Specialized operation room; For mechanical equipment, tools, and containers that are in direct contact with drugs, they are made of materials that do not change the drugs, such as using L316 stainless steel, etc., and pay attention to preventing the contamination of drugs by mechanical lubricating oil: the structure of the operation room and the ceiling, floor, and wall are easy to clean; The aseptic operation area should be inspected for particles, planktonic bacteria and sedimentation bacteria, and sterilized regularly.
3. Quality management system to ensure high-quality products.
1) In terms of management, for example, the quality management department exercises quality management responsibilities independently; Regular maintenance and correction of mechanical equipment, tools and measuring tools; Inspect the quality of each stage of the production process, including engineering inspection: planned and reasonable quality control, including quality management implementation plan, test plan, technical transformation, and quality research to meet the requirements of the production plan: track the batch number of the drug and make a record; Preserve the samples left by the product quality inspection after leaving the factory under appropriate conditions: collect information on consumer complaints about drugs, and improve production management and quality management at any time
2) In terms of equipment, for example, the reasonable allocation of operation room and mechanical equipment, the use of advanced equipment and reasonable process layout; In order to ensure the implementation of quality management, it is equipped with necessary experiments, inspection equipment and tools.
The above is an introduction to the three major objectives of the implementation of GMP, and pharmaceutical companies should produce drugs in accordance with GMP regulations. If the pharmaceutical company has any questions about GMP certification, you can consult us in time.