The Ten Core Principles of GMP Compliance

by t_king

The Ten Core Principals of GMP Compliance are the foundation of a successful quality management system. They provide a guide to manufacturing products safely and consistently, meeting customer needs and regulatory requirements.

The Ten Core Principals of GMP Compliance are:

  1. Written Procedures: these can be SOPs, job aids, work instructions, forms, batch records, PMs, etc.  We need to develop detailed instructions that clearly define what to do to achieve results that we want.
  2. Follow those procedures: building off of #1, we have to follow those procedures.  No shortcuts, no extra steps, and no forgetting.
  3. Documentation: accurately document your work.  Do it at the time of the work.  Use ALCOA+ as your guide.
  4. Trained: we must all have the competence to do our assigned tasks.  This includes training, gaining experience and confidence, coaching, mentoring, and oversight.
  5. Assessment: Are you doing it correctly?  Are you in control?  We must have periodic and planned audits of our work – similar to the building inspector for the foundation of our new home.  A nice home on a poor foundation will not stand.
  6. Workplace control: this includes the facility and equipment.  They have to provide the necessary protection from the wolves of pests, rodents, rain, bacteria, etc.  The equipment has to perform as we need it.  Is it clean?  Does it work all the time?
  7. Maintain: have scheduled maintenance not only on the equipment but on the facility as well.  Maintaining the building starts at the outside and goes inward from there.  Does it look good?  Does it work?
  8. Contamination Control: how do we control the wolves of contamination?  What is contamination?  Bacteria only?  What about particulate?  Other product?  Other virus?  Going from suite to suite, we can carry “contamination” from area to area.
  9. Quality control: build quality into everything.  Don’t just think or assume it is in control.  Know it!  How do you know that you are in control?
  10. Validate: Prove it works.  Provide the data.