Good Manufacturing Practice for Veterinary Drugs (abbreviated as "Veterinary GMP") is the basic requirement and criterion for veterinary drug production management and quality control. It is a statutory technical specification commonly adopted by countries around the world for the supervision and management of the entire veterinary drug production process.
About Veterinary Drug Good Manufacturing Practices
Veterinary drug production is a complex process involving numerous steps and management. Oversight at any stage can lead to product quality issues. To strengthen veterinary drug production quality management, the former Ministry of Agriculture promulgated and implemented Good Manufacturing Practices for Veterinary Drugs in 2002. Through the implementation of Good Manufacturing Practices for Veterinary Drugs, veterinary drug production practices are comprehensively regulated, encompassing personnel, plant facilities, equipment, materials, documentation, production processes, product distribution, and self-inspection, ensuring the quality and safety of veterinary drug products. This has played a significant role in promoting the healthy development of the veterinary drug industry and safeguarding the quality and safety of animal products.
# Let's learn about GMP standards!
What are GMP standards?
GMP stands for "Good Manufacturing Practice," a quality management system that requires companies to meet hygiene and quality standards in accordance with national regulations for raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. This system establishes a set of operational procedures to ensure reproducible product quality. All steps in this process are recorded to promptly identify and address any production problems.
What is the significance of implementing GMP standards?
GMP standards are the fundamental principles for pharmaceutical production and quality management. They apply to the entire production process of pharmaceutical preparations and key steps in the production of active pharmaceutical ingredients that affect the quality of the finished product. Pharmaceutical quality isn't determined by testing; rather, it's ensured through scientific, rigorous, and strict management and control of the entire production process. Therefore, qualified pharmaceuticals must meet two conditions: the drug itself must meet quality standards, and the entire production process must comply with GMP. This is why pharmaceutical manufacturers are required to maintain a GMP-compliant production environment. The vigorous implementation of pharmaceutical GMP is designed to minimize contamination and cross-contamination during the pharmaceutical production process, reducing the occurrence of various errors and is a key measure for improving pharmaceutical quality.
GMP Workshop Clean Area Requirements
GMP workshop clean areas are classified according to the ABCD classification system, primarily focusing on the number of bacteria and dust particles in the environment. Regulations also specify environmental temperature, humidity, pressure differential, illumination, and noise levels.
Level A: High-risk operating areas, such as filling areas, areas for storing stoppered barrels and open packaging containers that come into direct contact with sterile pharmaceutical products, and areas for aseptic assembly or connection operations, should utilize unidirectional airflow workstations (or hoods) to maintain the desired environmental conditions. Unidirectional airflow systems must provide uniform airflow throughout the work area, with a velocity of 0.36-0.54 m/s (guideline value). Data demonstrating and validating unidirectional airflow should be available. Lower air velocity may be used within enclosed isolators or glove boxes.
Level B: This refers to the background area within the Level A cleanroom for high-risk operations such as aseptic compounding and filling.
Levels C and D: These are cleanrooms for less critical steps in the sterile pharmaceutical production process.
GMP workshop cleanliness level standard
Static: This refers to the cleanroom environment when the cleanroom or clean area is constructed and the equipment is in place, but there is no human activity, no equipment in operation, and no production operations underway.
Dynamic: This refers to the cleanroom environment when the cleanroom or clean area facilities are operating as planned, with the specified number of personnel moving around in the agreed-upon manner, and equipment and production operations underway.
Dynamic Standards for Clean Area Microbiological Monitoring
Class A: Corresponds to the dynamic Class 100 standard, meaning it should maintain Class 100 cleanliness even under dynamic conditions.
Class B: Corresponds to the static Class 100 standard, meaning it only needs to meet Class 100 cleanliness standards under static conditions, and can meet Class 10,000 cleanliness standards under dynamic conditions.
Class C: Corresponds to Class 10,000 cleanliness standards, meeting Class 10,000 cleanliness standards under static conditions and Class D cleanliness standards under dynamic conditions, meaning Class 100,000 cleanliness standards.
Class D: Corresponds to Class 100,000 cleanliness standards.
Class B+A: This refers to high-risk operating areas within a cleanroom with an overall Class B cleanliness level, adopting Class A cleanliness control.
Workshop Level
Air cleanliness level requirements for different cleanrooms (areas):
The static pressure difference between the clean room (area) and the non-clean room (area) should be greater than 10 Pa; the static pressure difference between adjacent clean rooms (areas) with different cleanliness levels should be greater than 5 Pa; the static pressure difference between the clean room (area) and the outdoor atmosphere (including areas directly connected to the outdoors) should be greater than 12 Pa.
Your message must be between 20-3,000 characters!