On 18 November 2009 the European Commission has released the draft Chapter 1 Quality Management System of the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use for public consultation.
In order to get some broad feedback, the ECA decided to conduct a survey among its members to find out what challenges the envisaged changes pose in the context of the current quality assurance and GMP-systems.
The ECA asked 10 questions covering relevance of the change, actions in the companies, impact on the QS, statistical method use, inspection experience and future perspectives.
In total 197 individuals participated in the survey.
The first question is related to the relevance of the proposed changes. More than 67% think that they are important or are even of extreme importance.
More than one third of the companies have already implemented the newly introduced quality management systems or parts of it, the others will follow.
Especially those elements, which have been introduced recently like the PQR or others that reflect current GMP understanding like CAPA, are already implemented in most of the responding companies. Some requirements, e.g. Knowledge Management, Continuous Improvement Processes and Risk Management Systems may need some additional explanations to facilitate implementation.
Half of the companies use statistical methods to asses the processes (mainly for PQRs, deviation tracking/ CAPA and complaint handling). SixSigma or similar Lean Applications also seem to become more and more used in this context. However it seems that the pharmaceutical industry is looking for further clarification of the potential expectations that the European Authorities may have on the use of statistical methods.
Most of the responding individuals also see a new role of the quality assurance units. The ECA concludes the opinion that they see QA to operate more as steering than controlling sources, and will be integrated more into the operational processes or they see a change in the overall thinking, leading to a complete integrative approach of quality. More than two third welcome the developments in the guidance.
It also seems that the inspectorates are starting to focus more and more on the new approach.
Q: What was your Experience with the latest Inspection by the relevant Authorities?
According to the "ICH Q8, Q9 and Q 10 Questions and Answers Document" (step 5), there should be a development how authorities will perform their inspections: "The inspection process will remain similar. However upon the implementation of ICH Q8, Q9 and Q10, inspections will have greater focus (but not only) on how the PQS facilitates the use of e.g., Quality Risk Management methods, implementation of design space and change management."
The survey showed that most companies welcome the proposed changes.
As a general feedback, The ECA recognises the need for promotion of pharmaceutical quality systems and a welcome of the current developments.
However, the ECA survey revealed a challenge for the industry to comply with the regulation in short term. The necessary implementation will need to be accompanied with a culture change and might need a longer period (2-3 years). The implementation may have a relevant impact on resources/ activities within the industry and may affect particularly smaller organisations.
Detailed comments based on the survey have been sent to the EU Commission, Enterprise and Industry Directorate-General, Consumer goods, Pharmaceuticals.
Chairman European Compliance Academy (ECA)