Manufacturing compliance comprises the technical, legal, and corporate requirements, regulations and practices manufacturers must satisfy as they produce and market products. The risk of noncompliance has become an increasingly major concern in recent years, particularly for manufacturers with operations in multiple countries and jurisdictions. The growing array of manufacturing regulations becomes more challenging to meet due to the increasing role of governmental regulatory bodies in certain industry sectors, along with the emergence of global manufacturing compliance standards to address the increasingly global nature of manufacturing.
To ensure manufacturing compliance with this growing list of manufacturing regulations, many companies now employ compliance software and document control software, both of which represent integral components within a quality management software (QMS) solution.
Manufacturing compliance must be accounted for as manufacturers pursue the strategic goals of producing competitive products, operating profitably, and growing their business in an environment of increasing globalization and elevated product development costs. In market sectors ranging from medical device and biotech manufacturing to the automotive industry, efforts to achieve these goals are even more daunting due to the demands for manufacturing compliance originating from many different regulatory bodies, even within the same country. In the USA, for example, manufacturers must comply with quality standards and regulations from the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), and the Securities and Exchange Commission (SEC), among others.
Numerous areas of manufacturing compliance may come to bear on manufacturers directly or indirectly, including:
Manufacturing compliance in some sectors – most notably, medical device and drug manufacturing – centers around the FDA’s manufacturing regulations. 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, which dictate the 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.
Software developers have responded to this need by creating solutions for managing regulatory compliance within QMS and 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:
Moreover, new and harmonized standards for manufacturing compliance continue to be developed.
Meeting the challenge of manufacturing regulatory compliance requires establishing a consistent top-down strategy for ensuring compliance across the enterprise.
If management fails to create an environment that ensures manufacturing compliance – or lacks documentation to prove all necessary steps have been taken to achieve it – it can be held accountable for compliance breaches. Because of this, manufacturing compliance must be an ingrained part of day-to-day business operations, and therefore part of the organizational culture. Employee involvement in and acceptance of compliance tasks, including a complete understanding of manufacturing regulations, requirements and objectives, are integral parts of a sound compliance practice for manufacturing.