Current Good Manufacturing Practices (cGMP)
What is cGMP?
In the United State, Current Good Manufacturing Practices known as CGMP, refer to legislation that falls under the purview of the U.S. Food and Drug Administration (FDA).
These laws ensure that all pharmaceuticals and most food and beverage, cosmetic, and dietary supplement companies follow industry and best practices like hygiene, quality control, and more to ensure all products manufactured are safe and effective.
Current Good Manufacturing Practices are not limited to companies located within the U.S. Foreign companies that produce food, medical, and cosmetic products for distribution in the U.S. must comply with these standards.
The World Health Organization (WHO) has Good Manufacturing Practice guidance in place for pharmaceuticals and biological medicinal products. While the WHO is a separate organization from the FDA, these guidelines help ensure the global supply of medication and medical products meets safety guidelines.
Benefits of cGMP Certification
Who can be certified cGMPD Certification?
Document required forcGMP Certification
The extent of Documented Information differs as per:
Role of Shamkris and Process of cGMP Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Implementing Management System
Year on Year
CGMP is the main regulatory standard for ensuring pharmaceutical quality. This includes over-the-counter and prescription small-molecule drugs and biopharmaceuticals like vaccines, therapeutic blood products, gene therapies, antibodies and cell therapies (e.g. stem cell therapies).