Manufacturing compliance comprises the technical, legal and corporate requirements, regulations and practices manufacturers must comply with in order to produce and market products. The risk of non-compliance has become an increasingly major concern in recent years, particularly for manufacturers with operations in multiple countries and jurisdictions. This development has been further heightened by the increasing role of governmental regulatory bodies in certain industry sectors, along with the emergence of global standards to address the increasingly global nature of manufacturing.
The strategic goals of most manufacturing companies are to manufacture competitive products, operate profitably, and grow their business in an environment of increasing globalization and elevated product development costs. This is challenging enough in itself; but in market sectors such as medical device and biotech manufacturing, the task is even more daunting due to the additional burden of dealing with the various facets of manufacturing compliance originating from the FDA, EPA, and SEC, among others.
Numerous areas of compliance can come to bear on manufacturers directly or indirectly, including:
The core mandate guiding FDA regulatory oversight is consumer safety. As a result, the FDA has defined Good Manufacturing Practices (GMP) for both device and drug manufacturers that dictate the necessary measures that must be taken to ensure that quality systems and processes are in place to consistently produce safe, quality products. Therefore, manufacturers in these sectors seek a manufacturing certificate of compliance indicating that they meet GMP.
Meeting the challenge of manufacturing regulatory compliance requires establishing a consistent top-down strategy for ensuring compliance across the enterprise. Software developers have responded to this need by creating solutions for managing regulatory compliance within manufacturing execution systems (MES). For those in manufacturing sectors regulated by the FDA, these solutions must be compliant with Title 21 CFR Part 11 and Part 820. Part 11 requires pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers, contact research organizations, and other FDA-regulated industries (with some specific exceptions) to implement controls. These controls include audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.
With the advent of globalization, international standards have become increasingly important to manufacturers looking to be compliant across international markets. With the implementation of the EMC Directive (i.e., European Machinery Directive) and similar regulations in other countries, regulatory compliance has become a major milestone in product development and marketing for most manufacturers. Key international industry standards for manufacturing compliance include: