Business Agency, August 9th News The State Food and Drug Administration organized amendments to the "Administrative Measures for Certification for Quality Management of Drug Production"，and issued it a few days ago。Measures to point out，In the inspection team, if it is found that the application for the application for the application for the enterprise is suspected of violating the relevant provisions of the Drug Management Law，The evidence should be transferred in time through the observer to the pharmaceutical supervision and management department where the enterprise is located，and report the relevant situation to the drug certification inspection agency of the inspection team，The sending agency decides whether to stop the on -site inspection activity based on the situation。
In order to strengthen the management of drug production quality management specifications for inspection and certification work，Further standardized check and certification behavior，Promote the Implementation of "Specifications for the Management of Drug Production (Revised in 2010)"，The State Food and Drug Administration revised this measure。According to the website of the State Food and Drug Administration，This method has a total of 7 chapters，40 items，Perform from the date of release，"Notice on the Management Measures for the Management of Drug Production Quality Management Standards & GT;。
Pharmaceutical production quality management standard certification management measures (full text)
Chapter 1 General Principles
Article 1 In order to strengthen the management of the "Specification of Drug Production Quality Management" (hereinafter referred to as GMP) certification，According to the "Pharmaceutical Management Law of the People's Republic of China"、The Implementation Regulations of the People's Republic of China Drug Management Law (hereinafter referred to as the "Drug Management Law"、The Implementation Regulations of the Drug Management Law) and other relevant regulations，Formation of this method。
The second pharmaceutical GMP certification is a means of supervising the quality management of drug production enterprises in accordance with the law，It is a check of the pharmaceutical production enterprise's implementation of the pharmaceutical enterprise、Evaluation and decide whether to issue the supervision and management process issued to the certification certificate。
Article 3 The State Food and Drug Administration is in charge of the national drug GMP certification management work。Responsible for injection、Radial drugs、GMP certification and tracking inspection of drugs such as biological products and other drugs; coordinated by imported drugs GMP overseas inspection and national or regional drug GMP inspection。
Article 4 The provincial drug supervision and management department is responsible for in -depth injection in its jurisdiction、Radial drugs、Other pharmaceutical GMP certification and tracking inspection work other than biological products, as well as the drug GMP inspection work commissioned by the State Food and Drug Administration。
Article 5 The drug certification inspection institution established by the drug supervision and management department at or above the provincial level or above、On -site inspection、Results Evaluation and other work。
Sixth Pharmaceutical Authentication Inspection Institution responsible for GMP certification Stake Sports Bettingwork stake betting appshall establish and improve the quality management system，Make sure the quality of drug GMP certification work。
The State Food and Drug Administration is responsible for evaluating the quality management system of drug certification inspection institutions。
Chapter 2 Application, Acceptance and Examination
Article 7 Newly opened drug manufacturers or pharmaceutical manufacturers new production scope、New workshop，Apply for drug GMP certification in accordance with the "Regulations on the Implementation of the Drug Management Law"。
Pharmaceutical manufacturers, which have obtained the "Drug GMP Certificate", shall be 6 months before the validity period of the certificate，Re -apply for drug GMP certification。
Reconciliation of drug production enterprises、Expansion workshop or production line，It should be re -applied for the drug GMP certification in accordance with these measures。
9 Production enterprise applying for drug GMP certification，Fill in the "Pharmaceutical GMP Certification Application" in accordance with regulations (see Annex 1)，and submit relevant information。belonging to Article 3 of these Measures，Enterprise Sales、Autonomous Region、After the drug supervision and management department of the municipality directly under the Central Government has issued the review opinions of the daily supervision and management situation，The application information will be reported to the State Food and Drug Administration。belonging to Article 4 of these Measures，Enterprise will apply for data to be reported to the province、Autonomous Region、Drug supervision and management department of municipality directly under the Central Government。
Article 10 The drug supervision and management department at or above the provincial level shall review the drug GMP application and related information for form，Application materials are complete、It is accepted in accordance with the statutory form; the application information is not submitted in accordance with regulations，and the application materials are incomplete or in line with legal forms，On the spot or within 5 days, inform the applicant's content that needs to be corrected。
Article 11 Drug certification inspection agency conducts technical review of the application information，For supplementary information，It should be notified in writing to apply for an enterprise。Application enterprises shall according to the notification requirements，Complete supplementary information within the specified time limit，Overdue report，Its certification application is terminated。
The time limit for technical review is 20 working days from the date of acceptance。For supplementary information，Working time limit at actual delay。
Chapter 3 On -site inspection
Article 12 The drug certification inspection agency completes the application of the application data after completing the application of the information，The on -site inspection work plan should be formulated，Organize the implementation of on -site inspections。Establish a work plan and implement the on -site inspection time limit for 40 working days。
Article 13 On -site inspection implements the responsibility system of the team leader，The inspection group is generally composed of no less than 3 drug GMP inspectors，Randomly selected from the Drug GMP inspector library，should follow the principle of avoidance。Inspectors should be familiar with and understand the corresponding professional knowledge，If necessary, please hire relevant experts to participate in on -site inspections。
Article 14 Drug certification and inspection agency shall notify the application for enterprise before on -site inspection。On -site inspection time is generally 3 to 5 days，can be adjusted appropriately according to the specific situation。
1)，Responsible for coordinating and contacting the work related to the drug GMP on -site inspection。
Article 16 At the beginning of the on -site inspection，The inspection team shall present the GMP inspector certificate or other certification documents to the application enterprise，Confirm the scope of the inspection，Inform the inspection discipline、Note and corporate rights，Determine the company with the company。
Application enterprises should provide the relevant information required for inspection Stake Sports Bettingduring stake betting appthe inspection process。
Article 17 The inspection team shall be inspected strictly in accordance with the on -site inspection plan，Inspectors should do a good inspection record。Inspection scheme if you need to change，Approval of the drug certification and inspection agency of the inspection team sent out for the reporting group。
Article 18 After the on -site inspection is over，The inspection team responded to the on -site inspection to analyze the summary，and objective、Fair、Risk assessment of defects found in the inspection in fairness。
During the analysis summary, the company accompanied by the company should avoid it.
Article 19 Check the risk assessment of defects shall consider the product category、The nature of the defect and the number of occurrences of the occurrence。Defects are divided into serious defects、Main defects and general defects，The risk level is reduced in turn。Specific as follows:
(1) Severe defects and Drug GMP requirements are seriously deviated，Products may cause harm to users;
(2) The main deficit fingers and the requirements of the drug GMP are largely deviated;
(3) General defect refers to the Drug GMP requirements，But it has not yet reached serious defects and main defects。
20 Inspection Team to report on -site inspection to the application for the enterprise，The defect content found in the inspection，Signature of members of the inspection team and the person in charge of the application enterprise，Each part of the two sides holds one copy。
Application Enterprise has no objection to the defects found Stake Sports Bettingduring the inspection，Corresponding to the defect for rectification，and report the rectification situation in a timely manner to send the drug certification inspection institution。If you have any objections，Appropriate explanation。If you cannot form a consensus，The inspection team shall make a record and sign the signature of the members of the inspection team and the person in charge of the application enterprise，Each part of the two sides holds one copy。
Article 21 After the on -site inspection is completed，The inspection team shall check the situation according to the on -site inspection，Proposal of assessment of risk assessment principles。On -site inspection report should be attached to the inspector record and related information，signed by the members of the inspection team。
The inspection team should be within 10 working days after the inspection work，The on -site inspection report、Inspector records and related information to the drug certification inspection agency。
Article 22 On -site inspection If it is found that the application for the application for the application of the enterprise is suspected of violating the relevant provisions of the Drug Management Law，The inspection team shall promptly transfer the evidence to the pharmaceutical supervision and management department where the observer is located，and report the relevant situation to the drug certification inspection agency of the inspection team，The sending agency decides whether to stop the on -site inspection activity based on the situation。The inspection team shall record the situation in detail in the inspection report。
Turning out on -site inspection，Drug certification inspection agency shall investigate and deal with the investigation and processing department of the drug supervision and management department where the enterprise is located，Decide whether to restore certification checks。
Chapter 4 Approval and issue certificate
Article 23 The drug certification inspection institution may conduct a comprehensive assessment of on -site inspection reports in accordance with the rectification of the enterprise。When necessary，It can conduct on -site verification of corporate rectification。Comprehensive assessment shall be completed within 40 working days after receiving the rectification report，If on -site verification，Assessment time limit delay。
Article 24 The principle of risk assessment shall be adopted，Comprehensively consider the nature of defects、Severe degree and the category of the evaluated products evaluate the inspection results。
On -site inspection comprehensive assessment time，Low -level defects can be upgraded to the first or secondary defects，The defects that have been rectified can be downgraded，The completion of serious defect rectification should be conducted on -site verification。
(1) Only general defects，or rectification of all major and general defects proves that companies can take effective measures for correction，The results stake online sports bettingof the assessment are "consistent";
(2) There are serious defects or many major defects，It shows that the company's failure to effectively control the entire product production process，or the rectification or plan of the general and general defects cannot prove that the company can take effective measures to correct，Assessment results are "not in line"。
Article 25 of the drug certification inspection agency after completing the comprehensive assessment，The evaluation results should be publicized，The publicity period is 10 working days。If you have any objections to the content of the publicity，Drug certification inspection agency or reporting to the same level of drug supervision and management department to organize investigation and verification in a timely manner。During the investigation，Certification work pause。
No objection to the content of the publicity or the existing survey results of the objection，Drug certification inspection agencies shall report the results of the inspection results to the same level of drug supervision and management department，Approval by the drug supervision and management department。
Article 26 The approval of the drug supervision and management department，Meets to stake betting appthe GMP requirements of the medicine，issue the "Pharmaceutical GMP Certificate" to the application enterprise;，Certification inspection will not pass，Drug Supervision and Management Department notified the application for the application for the "Drug GMP Certification Approval Opinions"。The time limit for administrative approval is 20 working days。
Article 27 The drug supervision and management department shall announce the results of the approval。Provincial drug supervision and administration department shall upload the website of the State Food and Drug Administration。
Chapter 5 Tracking Check
Article 28 Drug Supervision and Administration Department in response to a pharmaceutical production enterprise organization holding the "Drug GMP Certificate" for tracking and inspection。"Pharmaceutical GMP Certificate" performed at least one tracking inspection during the validity period。
Article 29 The Drug Supervision and Administration Department is responsible for organizing drug GMP tracking and inspection;，Determine the content and method of tracking inspection，and evaluate the test results。The selection of the inspection team shall be in accordance with Article 13 of these Measures。
Drug certification and inspection agency of the State Food and Drug Administration is responsible for organizing or entrusted the provincial drug supervision and management department for drug certification and inspection agencies、Radial drugs、Tracking and inspection of biological products。
Article 30 The results of the tracking inspection according to Article 19 of these Measures、Article 24:。
Chapter 6 "Drug GMP Certificate" Management
Article 31 The content of the "Drug GMP Certificate" shall be consistent with the relevant content of the relevant content of the drug production license document。
Corporate name、The name of the production address is changed but the substantial change occurred，The document of the drug production license document is the certificate，Enterprises do not need to apply for changes in the "Drug GMP Certificate"。
Article 32 "Pharmaceutical GMP Certificate" within the validity period，Organizational structure related to the quality management system、Key personnel, etc.，Enterprises should be within 30 days from the date of change，Pick up to the original certificate agency in accordance with relevant regulations。The organizational structure and key personnel after its change should be able to ensure the effective operation of the quality management system and meet the requirements。
The original issuance authority should review the case of the company's preparation，On -site verification should be performed if necessary。If the review does not meet the requirements，The original issuance authority shall require the enterprise to correct it within a time limit。
Article 33 There is one of the following situations，The "Drug GMP Certificate" was recovered by the drug supervision and management department。
(1) Enterprise (workshop) does not meet the requirements of drug GMP;
(2) The company was ordered to discontinue production and rectification for violating drug management regulations;
(3) Others need to be recovered.
Article 34 When the Drug Supervision and Administration Department recovered the "Drug GMP Certificate"，It should be asked to correct。After the corporate correction is completed，Report the correction situation to the drug supervision and management department，On -site inspection by the drug supervision and management department，For the requirements of stake betting appthe GMP requirements of stake online sports bettingthe drug，Send back to the original "Pharmaceutical GMP Certificate"。
Article 35 There is one of the following situations，The "Pharmaceutical GMP Certificate" was sold by the original certificate agency:
(1) Enterprise "Drug Production License" is revoked in accordance with the law、Withdrawal，or being revoked according to law;
(2) Enterprise is revoked in accordance with the law、Decover the scope of production permits;
(3) The validity period of the company's "Drug GMP Certificate" has not continued;
(4) Others should cancel the "Pharmaceutical GMP Certificate"。
Article 36 The "Pharmaceutical GMP Certificate" that should be canceled at the same time is noted at the same time with other drug certification range，The drug supervision and management department can be based on the application of the enterprise，Re -issuing "Drug GMP Certificate" that has not been canceled and authenticated。The "Pharmaceutical GMP Certificate" issued by the issued by the number，The deadline for its validity period is the same as the original "Pharmaceutical GMP Certificate"。
Article 37 Drug production enterprise "Drug GMP Certificate" is lost or damaged，Statement on the relevant media，and can apply to the original issued authority for reissue。The original certificate agency accepted the application of the "Drug GMP Certificate" application，It should be supplemented by the original approval matters within 10 working days，The "Pharmaceutical GMP Certificate" number replenished、The deadline for the validity period is the same as the original "Drug GMP Certificate"。
Article 38 of the "Pharmaceutical GMP Certificate" receipt (issuing) back、Replenishment、Logistics and other management，The relevant information from the original issuance authority poses on its website。Provincial drug supervision and management department shall upload information to the website of the State Food and Drug Administration。
Chapter 7 Attachment
Article 39 "Drug GMP Certificate" is uniformly printed by the State Food and Drug Administration。
Article 40 These Measures shall be explained by the State Food and Drug Administration。
