Audit of the Pharmaceutical Substances Suppliers in the Enterprise Management System

Dr. A.A. Spiridonova, Associate Professor, Federal State Budget Educational Institution of Higher Education MIREA — Russian Technological University, Moscow, Russia, al.spiridonova@gmail.com

Assoc. Prof. Dr. E.G. Khomutova, Professor, Federal State Budget Educational Institution of Higher Education

MIREA — Russian Technological University, Moscow, Russia, khomutova@mail.ru

S.A. Galsanova, Graduate Student, Metrology and Standardization Department, Federal State Budget Educational

Institution of Higher Education MIREA — Russian Technological University, Moscow, Russia, ts.s.a@mail.ru

key words

supplier, audit, management system, GMP, pharmaceutical substance

References

In accordance with the Good Manufacturing Practice, raw materials of a pharmaceutical manufacturing enterprise must be procured only from approved suppliers. There are many methods for selecting and evaluating suppliers.
We believe that conducting an audit allows you to get a reliable understanding of the organization of the supplier’s activities and developed guidelines for conducting audit of pharmaceutical substances suppliers.
At the first stage, potential suppliers of the required pharmaceutical substance are searched (if it’s planned to purchase this type of feedstock for the first time). Then audit planning is carried out. A group of auditors together with a potential supplier draws up and coordinates an audit program. Next, a direct assessment of the supplier at the place of pharmaceutical substances production is carried out on the basis of the Protocol.
When evaluating potential suppliers according to the criteria of the Protocol, a list of counterparties is formed with which further work is carried out. The next step is to compile an audit report, where the expert group summarizes the entire audit, and concludes whether the supplier is approved or not according to the audit results. If the supplier is approved, if necessary, an additional assessment of the supplier can be made.
This is how the idea of the risks and opportunities that may arise with further relationships with the supplier.

1. RF Ministry of Industry and Trade Order of 14.06.2013 N 916 On approval of the Good Manufacturing Practice Rules.

2. Teryukhov Ya.I. Obzor metodov otsenki i vybora postavshchika v promyshlennoy otrasli [A review of the methods of assessment and selection of a supplier in the industrial sector], The successes of modern science and education, 2017, v. 3, no. 3, pp. 125–129.

3. Aleksandrov A.V. GMP: otsenka i audit postavshchika farmatsevticheskoy kompanii [GMP: assessment and audit of a pharmaceutical company supplier], Industrial Review. Pharmaceutical industry, 2008, no. 6, pp. 42–45.

4. GOST R ISO 19011–2012 Guidelines for auditing management systems.

5. GOST R ISO 9001–2015 Quality management systems. Requirements.

6. GOST R ISO 9000–2015 Quality management systems. Fundamentals and vocabulary.

7. GOST R ISO 9004–2010 Managing for the sustained success of an organization. A quality management approach.

8. GOST R ISO 31000–2010 Risk management. Principles and guidelines.

9. GOST R ISO/IEC 31010–2011 Risk management. Risk assessment methods.