Ensuring Quality & Regulatory Compliance when Collaborating with a Service Provider


In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMP’s.