13.10.2020 | LOGFILE Feature 39/2020

Excerpt from the GMP Compliance Adviser

Regulatory compliance - issue identification

Regulatory compliance - issue identification

5 min. reading time | by Mark Tucker


Issue identification is the most critical part of the process and relies on a team of people with high operational and GMP knowledge. All operational and quality areas should be represented and assessed.

The criteria for what is an issue in each area must be clearly defined, and is dependent on the final purpose of the list (see Figure 1.O-2 ). If this list is destined to be used only for inspection preparedness, you may only want to include issues that would be deemed critical or major by a health authority. If this list is to be used as a quality tool outlining all potential GMP gaps, the criteria will necessarily be much broader. For example, are all discrepancies going to be included on the list, or will only those discrepancies deemed to have a potential product impact be included? In QC, will all Out Of Trend results (OOTs) be included, or only results reported as Out Of Specification (OOS)?

Regardless of how the list will be used, it is imperative that the criteria for inclusion be consistently applied from site to site and from iteration to iteration within a site.

Figure 1.O-2 Some examples of potential risk assessment input values. It is very important to set and understand the boundaries you will use to populate your “risk log”, and at what frequency you expect updates.



Mark Tucker, PhD
Consultant, President of Mark Tucker, LLC
E-Mail: no483@marktuckerllc.com
GMP Compliance Adviser

GMP Compliance Adviser

This text is an excerpt from the GMP Compliance Adviser

The GMP Compliance Adviser is the world's most comprehensive GMP online knowledge portal that successfully combines theory and practice. It is used by more than 10000 professionals in over 50 countries. The GMP Compliance Adviser is divided into two parts:

  • GMP in practice: "How-to-do" interpretations and knowledge of our renowned industry specialists and according to international GMP rules.
  • GMP regulations: The most important GMP regulations from Europe, USA, Japan and many other countries (e.g. PIC/S, ICH, WHO, ...).

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