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Typical discrepancies of drug manufacturers quality system: what does the GMP inspection point out?

The fact that the pharmaceutical quality system is an integral part of the entire production process of a medicinal product, its features of implementation and ensuring the integrity of the data was discussed today at RegLec - EAEU by regulators and pharmaceutical manufacturers from both Russia and other countries.

Ekaterina Nikiforova, Head of the Department for Inspection of Production of Medicines of the FBU GILS and NP, based on the experience of GILS and NP in the field of checking production sites for compliance with appropriate manufacturing practices, noted that during the inspections for 2018 for critical inconsistencies the pharmaceutical quality system , enshrined in chapter 1 of the rules of GMP, ranked second and fourth place on significant nonconformities.

Among the main discrepancies in the field of FGC, affecting the quality of drugs and, as a consequence, having a potential threat to the life and health of the patient, Ekaterina Nikiforova noted the following:

• The manufacturer does not guarantee the release of drugs in accordance with the requirements of regulatory documents of the Russian Federation. There is no change control, which includes informing the Russian regulatory authority of the changes being made.
• The stage of production of the drug is carried out on the production site, not specified in the registration certificate.
• Evaluation of the quality of the finished product (for non-sterile solid dosage forms) and obtaining permission to release is carried out on the basis of quality control of bulk goods. Finished products in final packaging are not controlled.
• Quality Control System does not guarantee to conduct investigations of deviations and claims with the determination of their true causes.
• There is no provision for / no justification for the frequency of audits of suppliers of raw materials and auxiliary materials.
• There is no provision for periodic reviews of the functioning of the pharmaceutical quality system in order to continually improve products, processes and the system itself.

“Unfortunately, there are such cases when the manufacturer uses a pharmaceutical substance that is not included in the registration dossier for this drug,” Ekaterina Nikiforova told the conference participants.
Responding to questions from the audience about repeated inspections, a representative of GILS and NP reported that as of the current date, the institute carried out 1,966 inspections, and a number of inspections for extending the validity of the issued GMP certificate are scheduled for 2019. At the same time, "GILS and NP" leaves and on failures.

“Unfortunately, there is a tendency in the market, when manufacturers regard insignificant remarks as just comments of inspectors and do not pay them any attention. In the case when the same inconsistencies are identified during the repeated inspections, the inspector can raise it to the status of “significant” or “critical”, - said Ekaterina Nikiforova.

According to the press service "GILS and NP"

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