Compliance means obedience; and `regulatory compliance' refers to initiatives calculated to appease the regulatory authorities. For as long as this is your sole motive, all your GMP efforts will remain sub-optimal. Compliance is all about meeting norms. These norms can be approached in one of two ways: from beneath, where norms appear as the ceiling; or from above, where norms represent the floor.
The former approach is regulatory-driven compliance; the latter is culture- driven. Current and emerging regulatory expectations keeps practitioners of the former approach running to stay in the same place, while practitoners of the latter approach remain protected in a cocoon of comfort.
All great `leaders', organizations, individuals, regardless of the industry or profession they represent, have one link in common: they follow codes and disciplines that are largely self-imposed, and usually ahead of their times. This is what empowers and emboldens them to tread new grounds, blaze new trails and set new precedents. There is no discipline like self-discipline; no help like self-help.
Any practice, before it finds its way to a regulation, is first adopted by a `leader' in the industry, as part of his compliance programme, who demonstrates that it is not only superior to existing alternatives, but also raises the level of confidence of producing fewer defectives. Hence, actual practice always precedes its incorporation into any regulation. What you see as `regulation' is actually history of some achievement long past.
The `leader' has since raised the bar even higher, nudged the frontiers even farther. Which explains why he is always in a zone of comfort when it comes to regulatory compliance.
Compliance confers the following benefits, regardless of the approach taken:
- Product equivalence
- High-quality products
- Reduced regulatory burden
- Expedited drug approval
- Reduced time to market
- Low rework, rejection and recall rates
In the pharmaceutical and biotechnology industries, highly `regulated' as they are, the approach towards compliance is predominantly `regulatory':
- Understand and follow GMP regulations
- Validate manufacturing processes
- Implement effective master and batch production and control record systems
- Develop written procedures for critical process and control steps
- Provide employee training programmes
Regulatory compliance is conditional and its aim or goal or purpose is purely to satisfy regulatory requirements, achieve satisfactory inspectional outcome and avoid regulatory citations. On the other hand, when you do things as a matter of organisational culture or tradition, exceeding norms is not an unusual phenomenon. It is unconditional and the sole purpose is to achieve and sustain a high state of control.
While those aspiring for regulatory compliance follow procedures laid down by others, the leaders design, implement and control their own procedures; validate and document critical processes and operations based on sound scientific principles and best technical practices.
The results are that the former group can at most achieve a state of GMP which is reactive and unstable; which can easily be upset by changes in regulations and guidelines; where employees must be frequently retrained on changed systems and procedures; which is influenced by latest inspectional trends and citations. Compliance here is a dependent variable: depends on compliance with current regulations.
In contrast, wherever GMP is embraced as a gospel, there is automatic regulatory compliance, a high state of control, continuous improvement in operating and control systems; continual updating of skills and knowledge. It is proactive, independent of external trends and independent of cGMP regulations and guidelines current or emerging.
Such organisations operate at a higher level than cGMP, and well ahead because they operate in an environment with:
- a higher state of control designed into it
- a science and technology base
- an effective control & information system
(Inspired by and adapted from "Real Compliance and How to Achieve It", presented by Russell E. Madsen,Senior Vice-President, Science & Technology, PDA, at the 14th A3P Congress held in Biarritz, France 24-26 October 2001)
- (The author is with Center for GMP, Hyderabad)