What are Current Good Manufacturing Practices?
What are Current Good Manufacturing Practices
cGMP or Current Good Manufacturing Practice refers to a set of regulations put forth by the government to ensure that business, manufacturers, and packagers of products guarantee that their products are effective, safe, and pure. Initially, cGMP was put forth by the FDA for pharmaceutical products, medical devices, blood, and certain foods, but cGMP has expanded to include facilities, buildings, production, equipment, process controls laboratory controls, packaging and labeling, and returned or salvaged drug products.
At a high level, the goal if cGMP is to increase product quality by developing systems that proactively guarantee proper product design and control of manufacturing processes and facilities.
Quality
With cGMP, you are following regulatory guidelines to ensure that your products are safe, pure, and of the best quality.
Cost
cGMP is an expensive proposition. It needs you to invest in additional testing and state-of-the-art technologies.
Why is cGMP Compliance Important?
You are ensuring that:
Buildings and facilities are in good condition
Equipment is properly maintained and calibrated
Processes and procedures are reproducible and reliable
Employees are fully trained and qualified
Products are safe and of high quality
How to Remain cGMP Compliant?
To meet cGMP compliance and regulatory requirements, do ensure that:
All data is complete with necessary controls
Assign ownership to specific individuals
Authorize only selected individuals to make changes to records
Regular review of records for compliance, accuracy, and completeness
Ensure that data is secure throughout its history
Final Thoughts
The main purpose of cGMP is to ensure that manufacturers, business organizations, and packagers of pharmaceutical products, medical devices, and certain foods must proactively guarantee that their products are effective, safe, and pure.
By being cGMP compliant, you have facilities that are in good condition. Equipment that is carefully maintained and calibrated. Fully trained and qualified staff, procedures and protocols that are reproducible and reliable, and products that are of high-quality, safe, and efficacious.