Implementing Pharmaceutical Regulatory Requirements in a Medical Device-oriented Quality Management System

Recently, two Progress consultants worked in tandem to improve the Quality Management System (QMS) of a primarily medical device company to meet GMP requirements for products classified as pharmaceutical for specific markets 

This company has been developing and exporting surgical instruments and equipment to countries around the world. Part of their portfolio are products which are considered medical devices in most countries, but are classified as a drug product or combination product in certain markets. However, their QMS has been mainly focused on medical device requirements. Therefore, Progress was asked for their up-to-date expertise to assess and mitigate the gaps 

The goals of the project included improving compliance with GMP requirements for these products marketed in the US and Canada, and the management of contract manufacturers and distributors. Initially, one Progress consultant started the project as a project lead and later a second Progress consultant joined as a project member. Based on the gap assessment, the project lead had drawn up a project plan with deliverables and quality agreements that needed to be implemented or updated between the company and third parties. The project member developed a visual aid as a project tracker, in which the deliverables were further expanded and the project status could be monitored in real time.  

Current guidelines from the Food and Drug Administration (FDA), Health Canada and the International Council for Harmonisation (ICH) were consulted to ensure the QMS would be expanded in accordance with all applicable regulations. The Progress consultants revised numerous procedures and have written many new procedures for different processes, such as changes, deviations, stability studies, and annual product quality review specific to this type of products. They have also developed several PowerPoint training courses and trained company employees on the principles of GMP and the new quality procedures. 

The gaps identified were divided into different topics, each with multiple action items. A large part of the actions had been completed by the planned end date, pending some that depend on third party agreements, which are expected to be closed out soon.  

The customer was very satisfied with the results of the project. New quality processes to meet applicable GMP requirements for specific markets have been effectively implemented, meaning the organization now faces audits with full confidence. In addition, the mutual expectations between the company and its contract manufacturers and distributors are clearer due to the concretely defined and agreed quality agreements. The core team of the company shared with the Progress consultants that they had learned a lot from their expertise, that their knowledge had been enriched and that the training courses were clear and informative. These words naturally gave our consultants a great sense of fulfillment for their hard work. Moreover, they experienced a very pleasant collaboration with the entire team.