It’s a GMP Kind of Thing

The Five Ps of GMP

• • People- Every employee needs to be fully trained on good manufacturing practices to know what is expected of them and understand their responsibilities. Employees must follow the processes and the procedures strictly.
  • Products- Primary materials such as raw materials and components should all have a clear specification at every step of production. Every product produced should undergo constant testing, quality assurance, and comparison before going to the public. Packing, testing, and sampling the product must all be through the standard method.
  • Processes must be given to every employee and regularly checked to ensure they are being followed. The processes need to be documented clearly and consistently.
  • Procedures- Are a set of guidelines for a process or part of a process that every employee should follow. Any deviation from the process must be reported and investigated to determine the cause and the correction (See A Deviation has Occurred What’s Next Blog).
  • Premises- The facility should always be in a state of cleanliness to prevent accidents, cross-contamination, and fatalities. All equipment must be placed or stored correctly for the equipment’s best performance. All equipment must be calibrated regularly to ensure that it performs its functions accurately and consistently.

Several things could go wrong if these GMP guidelines are not followed. Your product could be produced inconsistently, become contaminated, accidents can occur, equipment not performing as it should, raw material and components not meeting specification, and records are unfinished and unclear. These are the issues that can cause your company problems, from 483’s from the FDA to consumer complaints. GMP regulations are enforced by the FDA, which will conduct audits on the companies process and procedures to make sure they comply.

There is a lot more that goes into good manufacturing practices. The information in this blog is just the surface. Principles, regulations, and concepts also play a huge factor. GMP, when followed, will protect your company from losses, waste, closures, recalls, fines, and FDA 483s (see Inspection Observations | FDA).

PSC Biotech® can help your company become compliant with good manufacturing practices, from creating documents to performing environmental monitoring on your facilities and calibrating your equipment (Equipment Calibration – Keeping Your Equipment in Top Working Order Blog).

Let us help you get GMP compliant.

Written by Ashley Castro, PSC Biotech® Consultant

Edited by Crystal McClain, PhD