Quality Management Systems

Quality Management is the cornerstone of any pharmaceutical company, and systems ensuring proper functioning of the Quality Operation have become indispensable. Having worked in a diverse range of companies and having developed a broad range of systems, we can support your Quality Assurance department where this will have the most impact.

Deviation, CAPA, Change Control

Efficient Deviation, CAPA and Change Control management is one of the most important aspects of the QMS. We offer knowledge of investigation methodology as well as technical know-how on how to create, execute and optimize procedures. In order to implement effective CAPA to resolve significant deviations, investigations to the root cause of an issue will be conducted using a variety of methods. Depending on severity, these can range from techniques such as a Gemba Walk, Fishbone Diagram, or 5 Why’s, to a full blown project management approach is case of critical failure.

To facilitate continual improvement quality improvements can best be implemented via the CAPA system. When due to the change impact is expected to the validated state of a facility, system, equipment or process, or if impact may be expected to the quality, safety or efficacy of the product, this will be managed via Change Control. Change Control can perceived as complex and through the experience we bring, we can support or lead the management of the activities required to properly implement the change.

Management Review

The ICH Q10 guideline, which is also implemented in the EU by the European Medicines Agency requires that “senior management should be responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness”.

Using proven methodology we can develop a management review system that is suitable for the client’s operation. We will together with the client determine what KPI (Key Performance Indicators) are the most appropriate to track during review. By using standardized templates, such as excel and powerpoint, we facility and simplify data collection so that once implemented collection of data can become a routine activity with minimal impact to other operations. If there is an opportunity we can develop queries in the electronic system that will simplify data collection even more.

Process controls and batch record review

By using standardized methods to assess the process to conduct a criticality analysis it is possible to implement those process controls that are most valuable. And by using the results of the criticality analysis it is possible to assess the (master) batch records so they can be improved, which will make batch review simpler and easier.

Quality Manual

Starting for a template we can build a custom made quality manual that can serve as the standard for the quality operation of your organisation.