Application of risk analysis to supplier and contractor management. Planning and carrying-out of audits of suppliers and contractors

Technological development of the pharmaceutical industry inevitably goes hand in hand with development of skills of the companies involved in implementation of the drug product life cycle and, therefore, complication of cooperation relations with them. With that, the entire responsibility before the customer for the product manufactured is born by the facility performing release control of the drug. And for this facility, the issue of managing the suppliers and contractors involved in the production chain takes indeed on particular significance.

The situation is very well reflected in the regulatory practice. During GMP inspections, more and more non-conformities are found which are related to suppliers and contractors; and such non-conformities may be assigned different levels of criticality.

GMP guidelines contain clear requirements for managing suppliers of pharmaceutical substances, excipients and materials, as well as for managing contractors. Herewith, regulators expect manufacturers to develop and implement specific requirements for suppliers and contractors. These requirements shall be based on risk analysis and must account for the specific features of the manufacture and complexity of cooperation relations.

• The workshop will cover the correlation between regulatory requirements, trends towards their revision and recommendations on working with suppliers and contractors, including those related to implementation of the risk-based approach at a pharmaceutical facility.
• A special focus will be made on practical consideration of the most frequent non-conformities found during GMP inspections as applied to management of suppliers of raw materials, excipients and other materials, as well as to management of contractors, and risk analysis.
• The Russian inspectorate will present the expectations in terms of risk analysis and supplier and contractor management within the framework of transition to GMP guidelines in the version adopted by the Resolution of the EAEC Council No. 77 as of 03 November, 2016.