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Satisfying your shareholders’ expectations, meeting the legal and cGMP expectations of the international regulatory bodies and staying on the right side of your board of directors is a basic requirement of staying in business.
However, often we see the law of unintended consequences raise its ugly head. For example, let’s say you identified a need to improve something in the workplace; possibly a process, SOP, laboratory method or system. You planned what to do, trained the staff and implemented the change. Yet some time later you noticed:
Why has this change, put in place with the best intentions, been so disruptive or difficult to comply with? After all:
From our research and case studies, this “doom loop” is remarkably common, yet relatively easy to avoid with:
We worked with a client on a remediation program that appeared at first to be impossibly daunting, expensive and unattainable.
The company had received a range of critical and major GMP deficiencies from the UK regulatory body, MHRA, and was facing a referral to MHRA’s Inspection Action Group (IAG).
Manufacturing had to be suspended pending a risk assessment of the non-compliances and while evaluating the effect of the non-compliances in terms of risks of misbranding and adulteration of the products. Shifts were cancelled, the supply chain was suspended and an urgent remediation program begun.
The essentials were done immediately:
NSF was asked to participate in leading the above listed activities advising on what to do to avoid false starts, wasted effort and reworked documents.
We worked with the company to:
We also underpinned the remediation program with a series of measured, targeted interventions in:
We mapped the whole range of expectations from the U.S. CFRs, the EU GMP Vol. IV guide and ICH guidelines. Using a deep knowledge of the FDA Quality Systems Inspection Technique, we:
With our involvement, the company made a critical decision that was estimated to reduce the time in IAG referral by six months and to allow the company to get back into production three months earlier than initially envisaged. These were critical not just for the performance of the business, but for its survival.