Whitepaper: Sustainable Compliance - the challenges of achieving and maintaining CMC Compliance
As the complexity of Pharmaceutical operations increases, Chemistry, Manufacturing and Control (CMC) compliance is becoming increasingly difficult to achieve and sustain. It is clear that the impact of noncompliances identified through Health Authority inspections can be extremely costly and can irrevocably damage a company’s reputation. The enormous resource and cost burden on companies which undertake CMC compliance programs needs a return on investment and at the very least requires mechanisms in place to sustain compliance once achieved, to make the process more than just a “snap-shot” in time.