Basic Knowledge of GMP Manual
- 发布时间：2021-05-13 11:32
Basic Knowledge of GMP Manual
- 发布时间：2021-05-13 11:32
Questions and answers ———————————————————————————————————————————
1.What’s the origin of GMP and what’s the Chinese meaning?
A：The appearance of GMP was related to the world-shacking thalidomide drug accident. Thalidomide is a kind of sedatives. In the late 1950s, Former Federal Germany Glennan Su Pharmaceutical Factory produced this drug to treat pregnant woman vomiting during pregnancy. In the six years after the sale, more than 12,000 malformed fetuses and 1,300 cases of polyneuritis were caused in 28 countries including the Federal Germany and Japan. America didn’t allow to import thalidomide at that time and was basically not affected. However, the serious consequence of this accident caused nervous feeling in America, America public took more concerns about drug supervision and drug regulations, which resulted a great alteration on Food, Drug and Cosmetic Law. The 1962 amendment significantly strengthened the enforcement of the Pharmaceutical Law in the following three aspects:
(1)Require pharmaceutical industries not only to prove the effectiveness of drugs, but also to prove the safety of drugs.
(2)Require pharmaceutical industries to report drugs’ adverse reaction to FDA
(3)Require pharmaceutical industries to implement drug production and quality management practices
In 1963, United States congress proclaimed the first GMP in the world.
GMP is the abbreviation of Good Manufacturing Practice. Because manufacture contains tow means, production and quality management. And GMP have already become the basic standards of drugs’ production and quality management in the international world, is a systematic and scientific management system.
2. What is the central guidance thought of GMP?
A: the central guidance thought of GMP implementing is: the formation of any drug quality is designed, not tested. To carry out this central guidance, we must to:
⑴Relatively fixed suppliers of main raw materials and packaging materials, insist on quality evaluation of suppliers
⑵The plant area is planned according to the principles of function and pollution prevention
⑶The plant production requires reasonable layout to avoid pollution and cross-contamination, and meet the specified cleanliness requirement.
⑷Pharmaceutical equipment is reasonable allocation, using advanced equipment and intelligent equipment, eliminating the equipment which easy to cause pollution and cross-contamination in production.
⑸All work is documented. Making documents really become the lows of company, against plagiarizing, copy, implementation of documents as a mere formality, or see documents as decoration.
⑹Standardize various operations
⑺Strict quality management requirement. Carrying out three-level quality management system, completing quality evaluation system, supervision system and reporting system. Continuously improving the level of drug standards.
⑼Systematic personnel training
⑽Regular does health work
⑾Completing after sales service,timely report major quality accidents and adverse reactions of drugs, let drugs quality under a rigorous supervision control, nip in the bud.
3、what is the differences between GMP and TQC?
A：TQC is totally quality control, GMP is a materialization in medicine production. TQC is decided by datas,the key is overall, GMP requires everything to be documented, the key is rigorous. Therefor, TQC is the guide thought of GMP, GMP is the implemented solution.
4、What’s the differences between QA and QC?
A: QA is the abbreviation for quality assurance,its main work is document formulation, investigation, supervision and finished product review and issuance. QC is the abbreviation for quality control, which utilizes microbiology, physics and chemical identification and other aspects to control the quality.
5、What are the main contents of GMP?
A：it can summarized as wetware, hardware, software. Wetware is personnel, hardware is plant, facility and equipment, software is organization, system, technology, operation, hygienic standard, recording, education and other management regulations.
(1)personnel: need a number of professionals, all staffs need to attend professional knowledge training and GMP knowledge training.
(2)Plant facility need to meet GMP cleanliness level requirements, drug must be produced in a clean area, used production equipment requires a combination of advancement and applicability, equipment need to be easy to clean and can’t react with any drug.(Generally made by stainless steel)
6、How many chapters does GMP consist and when it be implemented?
A: GMP has 14 chapters and 88 articles in total, and has been implemented since August 1, 1999. The latest version is version 2010.
7、what conditions should be met for starting a pharmaceutical production enterprise
A: Starting a pharmaceutical production enterprise must have the following conditions:
(1)Having legally qualified pharmacy technicians, engineering technicians and relevant skilled worker
(2)Having plants, facilities and hygienic environment suitable for its pharmaceutical production
(3)Having institution, personnel, and necessary instrument and equipment that can do quality management and quality inspection for production drugs
(4)Having rules and regulations to ensure the quality of medicines
8、Why say that GMP documents is the textbook of staff training?
A: Implementing GMP must be combined with the actual situation of companies, it includes organization, staff composition and quality, production and many other factors. For general staff, more important thing is that through basic GMP knowledge training, they will know how to follow the rules in the daily work process, in other words,they need to completely master basic work skills and GMP requirements.
9、Why GMP documents need to specify the approval date and execution date?
A: It is impossible to start execution on the day of GMP document approval. It needs to fulfill document issuance procedures. This process takes a certain amount of time, and at the same time, new approved document also need a training. So there is a gap between approval time and execution time.
10、what should be aware when GMP documents issued and recycled？
A: (1)Document issued must to be record, and signed by recipient. (2)Obsolete documents shall be recovered on the day when the new document is executed, and records shall be kept; (3)Obsolete documents are destroyed or archived by the document management department.
11、what is the three target components of GMP?
A: (1)Keep human errors to a minimum;(2)Avoid pollution for drugs;(3)build a rigorous quality assurance system, guarantee the quality of products.
12、what is SMP, and what contents it include?
A: SMP is the abbreviation for Standard Management Procedure. Its Chinese meaning is 标准管理程序. SMP includes: 1、document management; 2、materials management; 3、production management; 4、quality management; 5、equipment and measurement management; 6、verification management; 7、administrative management; 8、hygiene management; 9、personnel training management; 10、plant and facility management.
13、what is SOP, and what contents it include?
A: SOP is the abbreviation for Standard Operation Procedure. Its Chinese meaning is 标准操作程序. SOP includes: 1、production operating procedures; 2、quality control procedures; 3、equipment and measurement operating procedures; 4、materials processing procedures; 5、cleaning procedures; 6、hygienic operating procedures.
14、what is SOR, and what contents it include?
A: SOR is abbreviation for Standard Operation Records, it’s Chinese meaning is records, voucher files. SOR includes (1)Material management records;(2)Production operating records; (3)Quality inspection and management records; (4) Equipment operation and management records; (5)hygienic operation and management records; (6)sales records; (7)Verification report and verification record; (8)Personnel training and assessment records; (9)Document issuance and recycling records.
15、How to conduct GMP self-inspection？
A: In order to assure the validity of corporation quality assurance system,the whole process of drug production is consistently controlled. In the implementation process of GMP, after a period, organize special personnel to conduct a comprehensive self-inspection of the company's GMP implementation, or conduct a targeted self-inspection for company’s major quality issues, and list rectification measures and deadline. List the problems and make rectifications, then conduct random checks or follow-ups, and record the results. In the next period of self-inspection, fist check whether the problems last found have been rectified or not, and what are the problems in the rectification, and at the same time list the problems found this time as the content of the rectification. Self-inspection result and rectified solutions of each time all need a detail record.
16、How to classify the current GMP documents?
A: Current GMP documents are divided into two categories, standard documents and record, voucher and report documents. In standard documents category, it includes (1)technical standard documents; (2)management standard documents; (3)working standard documents.