1. What is cGMP?
cGMP refers to current good manufacturing practices (GMP) regulations enforced by the FDA. cGMP provides a system that ensures the proper design, monitoring, and control of manufacturing processes and facilities.
cGMP regulations require drug manufacturers to adequately control production operations to ensure the identity and quality of the drugs. cGMP includes establishing a robust quality management system, sound operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. When fully implemented, these formal control systems within pharmaceutical companies help prevent contamination, deviations, malfunctions, and errors, ensuring that drugs meet their quality standards.
cGMP stands for Current Good Manufacturing Practices. The first lowercase “c” stands for “current,” meaning “current.” Therefore, cGMP is also known as the current version of GMP or the current GMP standard. cGMP is an international pharmaceutical manufacturing management standard, originating from the 1997 International Conference on Harmonization of Good Manufacturing Practice (ICH for GMP) in Geneva, Switzerland.
In 1998, the US FDA led the drafting of the unified “cGMP for APIs,” or ICH Q7A.
In 1999, the EU and the US reached a mutual recognition agreement on cGMP for APIs, agreeing to mutually recognize each other’s cGMP certification results in the trade of APIs. cGMP focuses on production software, including on-site management, documentation, and quality control; it emphasizes process control, preventive quality control, and continuous Improvement and optimization.
Terms such as “21 CFR, 210, 211, Part 11” have specific meanings in the pharmaceutical and food industries.
The CFR (Code of Federal Regulations) contains statutes and regulations from various executive branches of the US federal government. These statutes and regulations cover a wide range of areas, including the environment, safety, and health. Part 21 of the CFR explicitly addresses laws and regulations related to food and drug administration. This regulation is further divided into several parts, numbered from 1 to 1499, covering all aspects of the production, processing, distribution, and regulation of drugs and foods.
Parts 210 (21 CFR Part 210) and 211 (21 CFR Part 211) address specific requirements for drug manufacturing and quality control. These requirements set standards for facilities, equipment, operations, controls, inspections, and records during the drug manufacturing process to ensure the safety, efficacy, and consistent quality of drugs.
Part 11 (21 CFR Part 11) explicitly addresses regulations related to electronic records and electronic signatures. With the rapid advancement of electronic technology, more and more drug and food companies are using electronic systems to manage and record relevant information. To regulate the use of electronic records and signatures, the US Food and Drug Administration (FDA) developed Part 11, which requires companies to ensure the authenticity, integrity, and traceability of these records and signatures to meet regulatory requirements for drugs and food.
II. What is GMP?
Like cGMP, GMP encompasses all aspects of the drug manufacturing process to ensure the quality of the drug.
The main Difference is that cGMP focuses on continuous Improvement, meaning it adopts the latest standards and technologies to ensure quality. At the same time, GMP is considered a set of principles that helps manufacturers develop processes to ensure quality. The cGMP outlined by the FDA is also considered more flexible.
GMP stands for Good Manufacturing Practice. It is the fundamental principle of pharmaceutical production and quality management, applicable to the entire pharmaceutical production process and key steps in the production of active pharmaceutical ingredients that affect finished product quality.
The World Health Organization began organizing the development of pharmaceutical GMP in the mid-1960s.
GMP is a set of mandatory standards applicable to industries such as pharmaceuticals and food. It focuses on requirements for production hardware, such as production equipment, as well as the management and control of the entire production process. It is a system for implementing GMP supervision and inspections and obtaining approval for pharmaceutical manufacturers and drug products in accordance with the law.
III. Differences between cGMP and GMP
The Difference between GMP (Good Manufacturing Practice) and cGMP (Current Good Manufacturing Practice) lies primarily in their requirements for pharmaceutical production management and quality control, as well as their emphasis. The following are the main differences between the two:
cGMP: It places greater emphasis on requirements for production software, such as operator behavior and how to handle unexpected events in the production process. It requires companies to use the latest technologies and systems to comply with regulatory requirements and ensure dynamic control and continuous Improvement of the production process.
GMP: It generally covers multiple aspects, including quality management, organization and personnel, plant and facilities, equipment, materials and products, validation and verification, document management, production management, quality control, and quality assurance. It focuses on requirements for production hardware, such as production equipment, as well as the management and control of the entire production process.
cGMP places higher demands on the completeness and accuracy of documents, including batch production records, batch packaging records, and batch inspection records, to ensure product traceability.
Quality Control: cGMP is more stringent in quality control, requiring extremely detailed regulations for all inspection steps and methods to prevent drug mix-ups and contamination at every stage of production.
Personnel Management: cGMP has more stringent and detailed regulations regarding personnel qualifications and responsibilities to ensure the quality of drug production.
Continuous Improvement: cGMP emphasizes optimizing the production process and ensuring product quality through constant Improvement, while GMP focuses more on fundamental control of the production process.