Good Manufacturing Practices

In order to ensure the safety and efficacy of pharmaceutical products, the FDA mandates that manufacturers follow a set of methodologies and procedures known as Good Manufacturing Practices, or GMP. These guidelines are the FDA’s way of regulating production processes that are constantly changing as new technology enters the scene.

Although specific regulations governing pharmaceutical production are often not feasible when dealing with novel technologies, GMP guidelines establish best practices as they evolve, while providing for extensive record keeping that helps reviewers determine the best way to make a drug. Manufacturers turn to GMP guidelines for direction on how best to perform laboratory processes such as calibrating instruments, preventing contamination, verifying drug stability, and labeling pharmaceutical products.

The FDA has defined current GMPs in 21 CFR 210 and 211. These mandates require drugs to meet quality, potency, and purity standards. In addition to delineating required drug characteristics, GMPs also mandate specialized training and lab environmental controls such as instructions for ensuring freedom from vermin, instructions for how to build and maintain clean rooms, directives on how to house and handle lab animals, and strict policies for compliance.

Ross ERP supports Life Sciences companies in their approach to Good Manufacturing Practices, and has the technology you need to support GMP record keeping and compliance.

Solution Brochure: Ross Enterprise for the Life Science Industry

Key Features:

• Implement best practices
• Keep accurate records
• Ensure up-to-date processes
• Prevent contamination
• Verify drug stability
• Properly label products

Here’s what Ross ERP for Good Manufacturing Practices can do for you:

Keep Better Records

Document your processes, including instrument calibration, vermin prevention and other health and safety protocols

Ensure Regulatory Compliance

Stay ahead of FDA mandates and implement GMP methodologies.