1. China cancels GMP certificates for drugs
Since December 1, 2019, the drug regulatory authority has cancelled the GMP certification for drugs, no longer issued GMP certificates for drugs, and has not authorized any institutions to issue GMP certificates. After the supervision and inspection of the drug manufacturer, the drug regulatory authority will issue a GMP compliance report.
2. Pharmaceutical GMP regulatory requirements
Article 45 of the Drug Administration Law stipulates that "raw materials and auxiliary materials required for the production of drugs shall meet the requirements for medicinal use and the relevant requirements for the quality control of drug production". Article 120 of the GMP stipulates that "the management and control requirements of packaging materials and printing packaging materials in direct contact with drugs are the same as those of raw and auxiliary materials". This is why as a pharmaceutical supplier, pharmaceutical customers may be required to comply with GMP requirements for pharmaceutical products. It includes drug research and development institutions, pharmaceutical intermediates factories, API factories, pharmaceutical excipients factories, pharmaceutical packaging materials factories, manufacturers providing equipment for pharmaceutical factories, institutions providing testing, animal experiments and clinical trial services for pharmaceutical factories. Even many pharmaceutical customers require packaging materials manufacturers that are not included in the pharmaceutical packaging material catalogue to establish a system based on GMP.
3. Focus of controversy
Chapter 1 of GMP regulation for drugs clearly defines GMP for drug production quality management and applies to drug manufacturers. The GMP compliance certificate of pharmaceutical suppliers does not belong to the scope of supervision of pharmaceutical regulatory authorities, nor is it authorized to be certified by a third party. It is only the GMP compliance evidence required by customers, or the enterprise can claim compliance after establishing and running GMP by itself. In this context, even if there are many problems in the GMP quality system and many non-conformance items in the GMP conformity evaluation, it does not necessarily affect the cooperation with pharmaceutical companies. Many pharmaceutical companies only hope to understand the quality system of the enterprise through GMP conformity assessment, so as to facilitate quality control in the later stage.
4. Evaluation of GMP conformance of drugs
Drug conformity assessment is also called Gap Analysis. It can be a full GMP clause or a partial GMP applicable clause. The inapplicable clause can be indicated as inapplicable in the audit report. Evaluation conformance or nonconformance will have a list of nonconformance items reported. Drug GMP conformance evaluation is entrusted by the enterprise to evaluate the quality system of the enterprise with reference to the quality system standard specified by the enterprise (Chinese GMP standard/GMP standard in accordance with the requirements of the target market customers). There is no recognised body, procedure or standard in the pharmaceutical industry and, in theory, a professional GMP advisory, training and audit body can carry out a GMP compliance assessment. Enterprises choose certification bodies, Shanghai Yue Fei or a drug expert they are familiar with, as long as the enterprise thinks that evaluation bodies or evaluation personnel are professional, there is no problem.
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