Contents
1. Drug Registration Inspections 2. Drug Supervision Inspections 3. Overseas Inspections 4. 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.
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.
- 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.
- 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;
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.
Reference Link
China CFDI Issues the 2021 Work Report on Drug Inspections
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