Drug manufacturers are under increasing pressure to bring products to the market faster and more cost-effectively while simultaneously meeting stringent quality requirements. Changing regulatory environments make the task of monitoring and adhering to quality standards challenging -- but the costs of non-compliance are high. Failing to comply with and satisfy the demands of regulations can result in heavy fines, product recall and in some cases, plant closure.
A dispute in 1999 involving a high profile company resulted in a $100 million fine for failing to correct defects in its manufacturing processes despite 6 years of warnings (Washington Post 03/11/99).
Maintaining compliance Regulatory compliance is not a one-off procedure and should be an integral part of an organization; companies must take into account compliance. This may involve devising an ongoing management process that includes:
- company-specific interpretation of current regulations
- creation of a systems inventory
- identification of systems that do/do not comply
- a detailed assessment of any gaps in compliance
- development of an active implementation plan, describing the necessary corrective actions required to bring systems into compliance
- prioritization of systems that need to be upgraded
- ensuring compliance of systems according to a prioritized list
- ensuring documentation is in place, archived and properly maintained.
Validation master plan. To avoid unnecessary work and obtain a good overview of the entire project, the plan should not repeat any information that is available elsewhere, for example, in SOPs. Rather, it should refer to established documentation. Regularly updating and reviewing template documents is required to make sure that all the latest regulations are incorporated with newly introduced company policies.