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3 Key Points of GMP-Compliant Programs

3 Key Points of GMP-Compliant Programs

Are all GMP programs created equal? Not necessarily, as GMP guidance defines what controls must be in place, but does not provide specifics. Thus, here are three key points to help lay the groundwork for a successful GMP-compliant program:

  1. Understand the requirements of the GMPs.  If the intent of the requirements is understood, then steps can be put into place to control the process according to GMP.
  2. Know what “in control” means.  “In control” depends on the process, but generally it means that there is “traceability of proof.”  A process must have a defined standard operating procedure (SOP) that outlines how the requirements of the GMP are implemented.  The SOP must be reviewed and approved in a controlled manner; this means that the original document is only accessible by the Quality unit and that Quality is the final approver.  When SOPs are revised, the revisions must be documented and a reason for the changes specified.
  3. Document data in a clear, concise, and traceable way.  If documentation is not recorded or is corrected inaccurately, it can corrupt the documentation trail.  As an example, if when raw data is written on a document, the original entry is obliterated and the original content is unreadable, it could bring into question why the entry was obliterated and cause the process to be questioned.  This could ultimately result in tainted products on the market.

These are only a few of key points to remember when creating your specific GMP-compliant program, but they are critical components that offer a foundation on which to build processes and maintain control.

 

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Michelle has over 14 years of experience in Good Manufacturing Practices (GMP) environments. Her experience with Six Sigma projects, documentation, procedures and training have been instrumental in providing new and diverse ways for continuous improvement. Being able to interpret GMP requirements into solid best practice efforts has made her an integral part of multiple teams striving to improve processes.

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