Table of contents
Adhering to basic GMP requirements is a critical part of a manufacturer’s quality management system (QMS). Failure to include these requirements can result in regulatory enforcement actions, not to mention the possibility of releasing poor quality product.
The World Health Organization defines “GMP” as “a system for ensuring that products are consistently produced and controlled according to quality standards.” Per the U.S. FDA, current GMPs, or cGMPs, “provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.”
Below are ten GMP principles a quality management system (QMS) should include as presented by xCellarate Managing Director Fenton Fong during the March 2021 Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms.”
- Clearly defined and systematically reviewed processes
- Validation of critical steps/processes
- Appropriate resources: personnel, buildings, equipment, materials
- Clearly written procedures
- Trained operators/personnel
- Complete records
- Complete, proper investigations
- Proper storage and distribution
- A clean, organized environment
- Quality Approval
No. 10 caps the requirements as all of the activities listed require oversight and review on a regular basis.
Additional Resources on Basic GMP Requirements
How Can a Small Pharma Firm Begin Building a Robust QMS?
What are the GMP Requirements for Data Integrity?
FDA Regulators Address GMP Compliance Issues
Find out how Redica Systems can help you build a strong quality management system (QMS) that adheres to GMP requirements. Below, see how you can search a set of 483s for observations involving deficient investigations for human drug GMP. Contact us to see how we can help you prepare for your next GMP inspection and build a robust GMP quality agreement that adheres to global GMP regulatory requirements.
