In the first blog posts we have analysed the paradigm shift in GMP and listed a series of support guidelines as evidence of these changes. In today’s entry we will analyse the actual impact of these changes on the pharmaceutical industry.
The changes introduced through the ICH Q8, Q9 and Q10 concepts are based on the knowledge creation and management and risk based approach. Companies have limited resources and therefore it should be decided if they invest in “control” or in “knowledge”. Health Authorities are promoting investment in knowledge through these changes. Efforts should be placed in critical issues or risk points and, to correctly decide where to focus the efforts, it is necessary to have complete knowledge about the processes.
New compliance approach obliges companies to rethink and redesign their processes and to definitively harmonize the contents of both procedures and records to the reality. This harmonisation is achieved through the full integration of quality processes into operational processes. This point is especially relevant since it breaks with many existent habits or paradigms and forces to change the companies’ organizational structures, roles, profile of key positions and resource distribution.
Among others, some elements of the change are as follows:
• Reinforcement of the development areas to guarantee the generation and management of knowledge for the subsequent management of manufacturing processes, the correct transfer of the processes to the internal or external productive area and the assistance in the resolution of recurring problems or the implementation of process improvements.
• Review of the validation policy to ensure validation exercises are, in fact, a state and as such are ongoing activities that accompany the life cycle of each element or process.
• Changes in the organization of the productive areas in order to have the necessary knowledge and resources to assume full responsibility for the processes (including quality aspects). Implementation of the “process ownership” concept.
• Changes in the quality areas to implement the concept of quality oversight and untie the performance of the activities under process owners’ responsibility, such as the preparation of technical content, the establishment of solutions to problems or deviations or the technical approach and execution of validations, among others.
These changes are highly complex and must necessarily be promoted by the companies’ senior management to be possible and, in most cases, external support to assess, design and implement the changes becomes necessary.
AFA’s audits also assess whether the organization has adapted to the necessary changes and therefore if its implementation is credible. To this end, indicators have been established for the level of GMP compliance and the maturity of the organization.