A quality system’s main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve process consistency. A quality system, when completely designed and maintained, will result in consistent, predictable processes that assure that medical products are safe, effective, and readily available to consumers. The administration plays an important role in the design, implementation, and management of modern strong quality systems models. Management, for example, oversees developing a quality system structure that is acceptable for the organization. A structured method to update processes in a controlled way is advised as part of a contemporary quality systems strategy. The outcomes of a management review are often recorded under a quality system. Corrective and preventative action, as well as change control processes, should be used to carry out planned activities.

The quality systems approach to CGMP compliance offers a methodology specifically designed to assist firms in identifying current compliance gaps and developing a manageable, controlled system for meeting the standards set for manufacturing and testing in areas such as raw materials, quality assurance, record-keeping throughout the manufacturing process, standards for cleanliness and safety, manufacturing personnel qualifications, product testing, production, and process controls. The route to compliance remediation is typically complicated, whether it involves developing a quality systems approach or simply enhancing an existing quality assurance system. Cross-functional collaboration, excellent project management, and the experience needed to predict risks and apply best practices are all required1.

If you have questions or need guidance from our team of experts, please call us at 248-987-4497 or email us at info@emmainternational.com to learn how we can help optimize your Quality System.

Reference:

  1. Fda.gov. 2006. Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations. [online] Available at: <https://www.fda.gov/media/71023/download> [Accessed 19 May 2022].
Vishnu Gotika

Vishnu Gotika

Vishnu is a Regulatory Affairs Specialist at EMMA International. She has experience in R&D product development, regulatory submissions, and compliance activities with pharmaceuticals, medical devices, and IVDs. She holds a Master of Science in Pharmacology and a Master of Science in Regulatory Affairs from Northeastern University.

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