National Service Hotline:
One-stop chemical compliance services, providing chemical compliance consulting services
Information Details
Cancellation of GMP certification means stricter supervision of drug production?
Release time:
2024-07-22 14:52
The cumbersome process of GMP and GSP certification has made many pharmaceutical manufacturers and distribution companies feel the strict supervision of the pharmaceutical industry. On September 25, 2019, the State Food and Drug Administration issued a notice on the study, publicity and implementation of the the People's Republic of China Drug Administration Law., It is clearly proposed to strengthen dynamic supervision and cancel the drug production quality management practice (GMP) certification and the drug business quality management practice (GSP) certification.
For GMP certification, the relevant state departments have determined to cancel the certification, do not accept applications and do not issue certificates. For the cancellation of GMP certification, does it mean that the regulation will be relaxed in the future? For enterprises, they will no longer comply with the corresponding standards? In fact, it is not. In comparison, it will be more stringent. Because there is the second half of the notice: the drug supervision and administration department will conduct dynamic inspection on the implementation of GMP and GSP at any time.
Cancellation of GMP, GSP certification, not GMP, GSP requirements will be abandoned. Instead, it replaces the previous static supervision with dynamic and whole-process supervision, transforming pre-approval into post-event supervision. The effect and intensity of regulation is also unprecedented. What is even more shocking is that this dynamic supervision is carried out in a "flying inspection" manner.
Flight inspection is the abbreviation of "flight inspection". Flight inspection is different from daily inspection. It can be said to be a surprise inspection without informing the object to be inspected in advance, with indefinite time and route.
The inspected unit was completely unaware of it and was caught off guard by the inspection agency. Only in this way can the inspection results be more reliable. In addition, apart from being unable to find out who the inspectors are, production enterprises and operating enterprises will also be accompanied by cross-checks in different places to avoid local departments from "protecting their children and covering up their ugliness" and hindering justice.
On July 18, 2019, the General Office of the State Council also issued the Opinions on Establishing a Professional and Specialized Drug Inspector Team. It is clearly pointed out that the national and provincial professional drug inspector teams will be built in the future, and the inspection of high-risk drugs such as vaccines will be further strengthened.
With the implementation of the above-mentioned national policies, the national and provincial professional drug inspector teams will be gradually set up in place, and the state will have the executive power to carry out all-weather, full coverage and stricter dynamic supervision of the national pharmaceutical industry.
Medicine is a special commodity, and the pharmaceutical industry is also a special industry, but no enterprise in the pharmaceutical industry can be a special class. Whoever is special will lose. The regulation of the pharmaceutical industry will only move towards stricter, not the slightest slack.
This time GMP and GSP certification were canceled, but dynamic supervision appeared in a normalized high-pressure situation, which is a good evidence of this.
We provide reliable registration consulting services for customers' registration of imported or domestic excipients. When reviewing related preparation products, we assist customers' products to pass the technical review smoothly, so that preparation enterprises can obtain the "Import Drug Registration Certificate"/"Pharmaceutical Product Registration Certificate" or drug approval number, thus realizing CDE to mark the excipient registration number "through technical review", I .e. "A" status.
Except for the raw and auxiliary packages that are prohibited, eliminated or canceled by the state, the drug examination center shall transfer the relevant information to the registration platform and give the registration number to the raw and auxiliary packages that meet the following conditions, and the registration status shall be marked as "A":
1. Approve the API whose expiration date of the certificate is not earlier than November 27, 2017;
2. has been accepted and completed the review and approval of the API, including the provincial bureau in accordance with the State Food and Drug Administration Note [2013] No. 38.
Application for the transfer of API technology reviewed in the document;
3. Pharmaceutical excipients and pharmaceutical packaging materials that have been accepted and reviewed;
4. Pharmaceutical excipients that have obtained approval documents;
5. The expiration date of the approval certificate shall not be earlier than August 10, 2016.
For APIs used for generic or imported domestic listed drug preparations, the registrant of the API may conduct individual review and approval after registration, with the registration status of "A" for those who have passed the review and approval and the identification of "I" for those who have not passed the review and approval ". The time limit and requirements for review and approval shall be implemented in accordance with the current Measures for the Administration of Drug Registration and other relevant provisions.
If the API is labeled "A", it indicates that the API has passed the review and approval. API registrants can print their own approval documents, quality standards and labels on the registration platform for GMP inspection, import customs clearance, etc.
For APIs that have not been registered on the platform but submitted research data together with the drug preparation registration application data, the regulatory authorities shall mark the relevant information of the API in the drug preparation approval certificate, which can be used for GMP inspection and import customs clearance of the API.
For the raw and auxiliary materials registration platform, it is easy for everyone in state A to understand and can safely choose to use it. What about the raw and auxiliary materials in state I?
There are two cases when the state is I:
1, has been registered, there is no preparation for related review
2, ongoing related review
The following is a question and answer about GMP:
What is the origin and meaning of GMP?
A: The emergence of GMP is related to the world-shocking drug toxicity of thalidomide (thalidomide, thalidomide), a sedative. In the late 1950 s, it was produced by the former Federal Republic of Germany's Glennansu Pharmaceutical Factory. At that time, it was used to treat pregnant women with vomiting. In the 6 years after the sale, it was successively in 28 countries including the Federal Republic of Germany and Japan, causing more than 12000 cases of malformed fetuses. 1300 cases of polyneuritis. The United States did not approve the import of "thalidomide" at that time, and it was basically not affected. However, the serious consequences of this incident caused anxiety in the United States. The American public was strongly concerned about drug supervision and drug regulations, which led to Congress's approval of the Food, Drug and Cosmetics Act. And major amendments. The 1962 Amendment significantly strengthened the enforcement of the Drug Act in three areas:
(1) Pharmaceutical companies are required to prove not only the effectiveness of drugs, but also the safety of drugs.
Require pharmaceutical companies to report adverse drug reactions to the FDA.
(3) Require pharmaceutical companies to implement drug production and quality management practices.
In 1963, Congress enacted the world's first GMP.
GMP is an abbreviation of Good Manufacturing Practice in English. The literal translation is "good production practice", because the word Manufacture contains the dual meaning of production and quality management, and GMP has become the basic criterion of drug production and quality management in the world, and it is a systematic and scientific management system. Therefore, the translation of "drug production and quality management norms" is closer to the meaning of "GoodpracticeintheManufactrigandQualitycontrolofDrugs" in the original text.
What is the difference between GMP and TQC?
A: TQC is total quality management, GMP is the concretization in pharmaceutical production. TQC is to use data to speak, the most important thing is a "full" word, GMP is to check everything with evidence, the most important thing is a "strict" word. Therefore, it can be said that TQC is the guiding ideology of GMP, and GMP is the implementation plan of TQC.
What are the main contents of GMP?
Answer: It can be summarized as wet parts, hardware and software. Wet parts refer to personnel, hardware refers to plant, facilities and equipment, software refers to organization, system, process, operation, health standards, records, education and other management regulations.
(1) Personnel: A certain number of professional and technical personnel are required, and all staff are required to carry out professional knowledge training and GMP knowledge training;
(2) The plant facilities shall meet the requirements of GMP cleanliness level. When producing drugs, they must be produced in a clean area. The production equipment used shall be combined with the advanced nature and applicability. The equipment is easy to clean and shall not change with drugs (generally made of stainless steel);
(3) Software: It is necessary to formulate perfect technical standards, management standards, working standards and record documents. It includes production, technology, quality, equipment, materials, verification, sales, plant, purification system, administration, health, training and other aspects.
Why GMP documents are teaching materials for staff training?
Answer: The implementation of GMP must be combined with the actual situation of the enterprise, including organizational structure, personnel composition and quality, products and other factors. For ordinary employees, it is more important to pass basic GMP knowledge training and how to do it in the daily work process. There are rules to follow and follow the rules, that is, to fully master the basic work skills and GMP requirements.
Why do GMP documents need to specify approval dates and implementation dates?
Answer: It is impossible to start the implementation on the day of GMP document approval. It is necessary to fulfill the document issuance procedures. This process takes some time, and the newly approved documents also need training. So there is an interval between the approval date and the execution date.
What should be paid attention to when issuing GMP documents and recycling outdated documents?
Answer: (1) The issuing documents must be recorded and signed by the addressee; (2) Obsolete documents shall be recovered on the day when the new documents are executed and recorded; (3) Obsolete documents shall be destroyed or archived by the document management department.
What are the three main objectives of GMP?
Answer: (1) Control human errors to a minimum; (2) Prevent contamination of drugs; (3) Establish a strict quality assurance system to ensure product quality.
How to conduct GMP self-examination?
Answer: In order to ensure the effectiveness of the enterprise's quality assurance system and the consistent control of the whole process of drug production, during the GMP implementation process, special personnel are organized to conduct a comprehensive self-examination of the enterprise's GMP implementation every other cycle, or conduct a targeted self-examination of the enterprise's major quality problems, and list the rectification measures and time limit. The problems found out are listed, rectified, and then spot checks or prevention are carried out, and record its results. In the next cycle of self-examination, first check whether the problems found last time have been rectified and what are the problems in the rectification. At the same time, the problems found this time will be listed together as the contents of the rectification again. The results of each self-examination and the rectification plan shall be recorded in detail.
How are the current GMP documents classified?
Answer: The current GMP documents are divided into two categories, namely standard documents and record voucher report documents. Under the standard category, it is divided into (1) technical standard documents; (2) management standard documents; (3) working standard documents.
The production of new drugs must be approved by what department, the production of the dosage form of the workshop must be GMP certified?
A: When a new drug is produced, it must be approved by the State Drug Administration and issued with an approval number, and the workshop that produces the dosage form must pass GMP certification.
Can generic drugs be made without GMP certification?
Answer: No. The State Drug Administration stipulates that only enterprises that have passed GMP certification can imitate drugs.
What are the requirements for generic drugs?
Answer: ① When imitating drugs, it is necessary to check with the "Committee on Protected Varieties of Traditional Chinese Medicine" before imitating varieties that have not been protected by traditional Chinese medicine. ② Fill in the application report for imitation and obtain the approval of the provincial and national drug administration. ③ Strict trial production according to the imitation variety process; ④ Carry out standard improvement work (such as increasing content determination, etc.) on the basis of the original standard; ⑤ Stability test; ⑥ After reporting to the provincial drug inspection and review, report to the State Drug Administration for approval.
Previous Page
Previous Page
National Service Hotline:
Beijing Headquarters: D10, Floor 4, Block A, Borui Building, No.26, Dongsanhuan North Road, Chaoyang District, Beijing, China
Tel: 86-010-6471 0683
Shanghai: Room D308, Zhongyi International Building, Puxing Highway 800, Minhang District, Shanghai
Tel: 86-021-3478 3993
Guangzhou: Room 201, Xinying Technology Park, No. 313 Jinxin Avenue, Panyu District, Guangzhou
Tel:400 660 1329
E-mail：nar@china-reach.net
Copyright: New Anrun (Beijing) Consulting Co., Ltd.
