On June 26, 2022, China Center for Food and Drug Inspections (CFDI), a public institution under National Medical Products Administration (NMPA), issued the 2021 Work Report on Drug Inspections. The Report says that in 2021, CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections.
1. Drug Registration Inspections
1.1 Definition
Drug registration inspections verify the authenticity and consistency of the application materials, the commercial production condition, the compliance of R&D and manufacturing processes, and data integrity, etc.
1.2 Data
In 2021, CFDI completed 1,214 drug registration inspections, including
1,066 inspections for clinical trial applications and marketing authorization applications;
148 inspections for the generic drugs' quality and therapeutic equivalence evaluations.
10 inspections reported failure results.
1.3 Problems
Problems found in pharmacology and toxicology study inspections mainly include
Inconsistency in the laboratory animal testing data;
Lack of standard operation procedures for re-testing and selecting data;
Inconsistent standards for data processing;
Incomplete records of device usage and maintenance, the receiving of test substance, and transport.
Problems in clinical trial inspections mainly are
The original medical records are lacking in details or incomplete;
The inspected party didn't report the deviance from the clinical trial plan;
Incompliance in filling in and revising some scaling tables;
Inaccurate records of using drugs in the clinical trial;
Incomplete records of safety information;
Incomplete records of using concomitant medications.
Problems in the inspections for CMC R&D sites and manufacturing sites mainly lie in
Data are unreliable for untraceability or incompleteness;
Part of the original records are inconsistent with the application materials;
The technology transfer is insufficient;
The verification and validation are insufficient;
The applicant is unqualified for commercial production.
2. Drug Supervision Inspections
2.1 Definition
Drug supervision inspections are initiated by CFDI under NMPA's deployment based on risk levels. These inspections check out whether drug marketing authorization holders (MAH) and manufacturers are compliant with relevant laws, regulations, and GMP.
2.2 Data
In 2021, CFDI completed 101 supervision inspections, including
10 inspections for traditional Chinese medicines;
5 inspections for chemical drugs;
84 inspections for blood products and other biological products;
2 inspections for anesthetics and psychiatric drugs;
3 inspections announced failure results.
2.3 Problems
Main problems found in drug supervision inspections are
The qualified person (QP) did not fulfill the responsibility of releasing materials and products according to the required procedures;
The actual production batches exceed the technology validation scope;
The company cannot provide the records of investigating the out-of-specification (OOS) test results;
The company did not take sufficient measures to maintain the factories, clean the devices, and control dusts during the manufacturing process so that there are risks of contamination and cross-contamination.
3. Overseas Inspections
3.1 Definition
Overseas inspections are conducted on pharmaceutical companies whose manufacturing sites are outside China.
3.2 Data
Due to the cross-border travel restrictions after the COVID-19 outbreak, CFDI tried carrying out overseas inspections remotely. In 2021, CFDI completed 6 remote overseas inspections, among which 1 reported failure.
3.3 Problems
Primary problems found in overseas inspections are
Seriously deficient quality control for active pharmaceutical ingredients (API), excipients, and finished dosage forms (FDF).
Insufficient correction and prevention measures for complaints about recurrent foreign matters (in the products);
The company did not effectively control the changes;
The company did not re-validate critical manufacturing technologies and operation procedures periodically;
The responsibility of releasing APIs is unclear in the quality agreement.
4. License Inspections
4.1 Definition
Authorization inspections evaluate if applicants of drug manufacturing/supply licenses are qualified to manufacture/supply drugs.
4.2 Data
In 2021, CFDI conducted 47 license inspections, including
9 license inspections for radioactive drugs;
38 GLP certification inspections.
One GLP certification inspection was concluded with failure.
4.3 Problems
Main problems found in GLP certification inspections are
The quality assurance department is incapable of fulfilling its responsibilities;
The facility management of the institution is unqualified;
The facility design and management for laboratory animals are insufficient;
The trial did not strictly comply with the standard operating procedures (SOP);
The authority of different computer accounts is inappropriately designated.
Main problems uncovered in radioactive drug inspections are
The document compilation is incompliant;
The validation contents are incomplete;
The company did not strictly follow the supplier audit requirements.
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