The compliance challenge has become more complex in recent years as a result of significant changes at FDA and other federal government agencies, ranging from new electronic signature regulations to new manufacturing best practices. There also have been significant changes in the world market such as the increased international trade of drugs, increased drug counterfeiting, and the threat of terrorist acts targeting the food or drug supply, which have a highly visible impact on public health. In addition, increased industry consolidation makes compliance more challenging at huge multinational corporations, which have grown through the acquisition and mergers of companies with disparate compliance initiatives and approaches.
In addition to dealing with manufacturing compliance, pharmaceutical companies today grapple with at least three other sets of requirements, including:
Increasingly pressured by competition from generics and public pressure to lower the cost of drugs, many innovator companies see the need to abandon the status quo to focus on improving productivity, efficiency, and quality. Unfortunately, they have often been constrained by the very regulatory processes put in place to protect the public.
Companies operating in the United States may soon get some regulatory relief, thanks to a shift in the way FDA plans to regulate the industry, emphasizing a quality-by-design model as opposed to its historical quality-by-testing results approach and encouraging a risk-based approach to compliance and enforcement.
Thus, pharmaceutical manufacturing is in a state of transition, as the industry evaluates long-standing practices and new technologies and FDA introduces new regulatory paradigms. Increasingly, information technology is playing an important role in helping companies streamline compliance and improve operational efficiency throughout their supply chain, manufacturing, and distribution operations.