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What are the characteristics of the new version of GMP in China compared with the old version?
The GMP standard is a set of compulsory standards applicable to the pharmaceutical and food industries. It requires companies to meet hygienic quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. The operating specifications of the operation help the enterprise to improve the sanitary environment of the enterprise, and timely find out the problems in the production process and make improvements. In brief, GMP requires that production enterprises should have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of products (including food safety and hygiene) meets regulatory requirements.
In March 2011, the State Food and Drug Administration issued and implemented the second GMP since the country's mandatory GMP management. This GMP is based on the EU GMP and is based on the GMP of the WHO, the United States and Japan, and is based on the actual situation of China's pharmaceutical manufacturers. The promulgation and implementation of the new version of GMP will level the quality management of pharmaceutical manufacturers, and will play an important role in conforming to internationally accepted standards. Compared with the 1998 version, the new GMP has the following features:
I. Changes in personnel and organizational requirements
In addition to the new version of GMP, the requirements for personnel education, qualifications, experience and training have been increased. The concept of "key personnel" is put forward, and it is clear that the person in charge of the enterprise, the quality attorney, the person in charge of quality management, and the person in charge of production management are the main managers and persons in charge of the quality of drugs in the pharmaceutical and gold industry. The standard requirements for training, experience, and training have made very clear rules: the respective responsibilities and common responsibilities of these four types of personnel have been very clearly defined, their legal status has been strengthened, and these personnel have legal guarantees to perform their duties independently. .
Changes in hardware requirements
1. Plant facilities
Added detailed standard requirements for the four major areas related to drug quality, including the production area, production auxiliary area, storage area and quality control area. In addition, the key is to change the design and division principles of the clean area. The cleanliness level attracts A, B, C, and D standards. It is required that the temperature and humidity of the clean area are compatible with the pharmaceutical production process (operation). . The basic pressure difference in different cleanliness areas increased from SPa to 10Pa.
2. Instrument and equipment
Refined the cleaning and storage requirements of the equipment; refined and strengthened the management of meter-only calibration (including calibration calibration), range coverage, and scope of use of instruments and equipment, and proposed that automatic or electronic equipment should be regularly calibrated and Inspection concept.
3. Materials and products
The scope of material management has been significantly expanded, and the management content has been refined. The standardized management of raw and auxiliary materials, intermediate products and products to be packaged, internal and external materials, and finished products has been separately classified, and the basic management standards for these materials have been strengthened, such as material coding Management, material identification management, setting of storage conditions for materials, computerized system management, etc. have clearly stipulated.
Changes in software (document) requirements
The new version of GMP has greatly improved the content of file management. Specifically, it can be divided into 6 aspects:
1. Increased the scope of file management
The new version of GMP incorporates all aspects related to product quality, including quality standards, production recipes and process regulations, procedures, records, reports, etc. into the scope of GMP file management.
2. Refined the establishment and operation requirements of the file system
It is stipulated that enterprises should establish management systems for drafting, revising, reviewing, approving, fine-tuning or withdrawing, duplicating, keeping and destroying documents, and have a management mechanism for document distribution, revocation, duplication, and destruction. The document itself must also have a public coding system. All drafts, revisions, reviews, and approvals of documents related to product quality should be performed by persons authorized by the quality management department, and approved by the quality and silver management department.
3. Strengthened the management of record files
It is clearly proposed to operate according to various standards and standards. The various records and reports formed are mostly documents and must be systematically managed. The concept of batch files is also proposed. Each batch of drugs should have batch files, including batch production. Records, batch packaging records, batch inspection records, and drug release audit records, batch sales records, and other records and documents related to batch products.
4. Clarified the responsibility of the quality department for GMP file management
Should go through the extensive audit of the quality management department. Batch files should be stored and archived by the Quality Management Department's CMP-related documents (including records) department.
5. Refined the specific content of the preparation of various documents
Relevant documents are divided into five categories according to their nature, including quality standards, process regulations, batch production records, batch packaging records, and operating procedures, and the five types of documents are specifically defined, defined, compiled, reviewed, approved, and revised. To improve the management standards of these files.
6. Added content of electronic records management
With the widespread use of computer program control systems, the new version of GMP adds electronic record management content.
Changes in on-site management requirements
1. Production site management
The new version of GMP incorporates the content of sanitary management in the 1998 version of CMP, forming a broader clean production management, re-thinning and refining the prevention requirements for contamination and cross-contamination and the prevention requirements for mixed cleaning and errors, and initially proposed production overpass Control requirements and quality risk analysis requirements for the production process.
2. Quality management site requirements
The new version of the CMP introduces the concepts of quality assurance and quality control, clarifies the management requirements for drug quality management, quality assurance, and quality control, and introduces the concept of quality risk management.
3. Validation management
Introduce new concepts such as design confirmation, verification status maintenance, and verification master plan, strengthen and refine the control requirements for the verification life cycle, completely propose technical requirements for equipment from design verification, installation verification, operation verification to performance verification, and propose processes Technical requirements such as verification and cleaning verification are of great significance for improving the verification level and consolidating the foundation of the GMP management system.