Types of manufacturing regulations and compliance mandates
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, contract 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:
- ISO 9001
- ISO 13485
- IEC 61215
- IEC 61646
Moreover, new and harmonized standards for manufacturing compliance continue to be developed.
Management Imperative for Compliance
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.
