Inside PIC/S: Top GMP Deficiencies - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Inside PIC/S: Top GMP Deficiencies
Comparison of the top GMP deficiencies cited by the PIC/S Participating Authorities.

Pharmaceutical Technology
Volume 36, Issue 4, pp. 135-137

Analysis and outcome

Table I: Comparison between summary of groups.
For a comparison between groups (most frequently cited deficiencies and most severe deficiencies), please see Table I. In general, PIC/S Participating Authorities use different GMP deficiency classification models in the following ways:
  • Some use the model developed by the UK MHRA.
  • Some use a model based on the Chapters and Annexes of the PIC/S GMP Guide.
  • Some have their own classification methodology.
  • Some members do not have formal analysis trending on GMP deficiencies.

There is no significant differences among regions in terms of the way GMP deficiencies are inspected and cited. There is, however, a correlation between the most frequent GMP deficiency classes and the most severe GMP deficiency classes. This implies that there is harmonization across all PIC/S Participating Authorities.

The 10 most frequently cited GMP deficiency classes means that the industry is weak in these areas and inspectors should communicate more effectively and efficiently to the industry on such weaknesses.

Different level of details of the deficiency classes model was noted. A model that could be accepted by most PIC/S participating authorities may be required going forward.

Some of the most frequently cited GMP deficiencies may due to ease of detection as part of the inspection process (e.g., documentation–manufacturing was the most frequently cited deficiency). The design and maintenance of premises ranked second, which may relate to aged buildings or saving on maintenance budget.


The following items were recommended and presented to all participants in November 2011.

Data trending. Some agencies did not conduct such GMP deficiencies analysis/trending exercise over a defined period of time. It is recommended that all PIC/S Participating Authorities should implement such an exercise for analysis and trending within a defined period (e.g., annually) and subsequently, for trending across different years.

Common model. It would be useful for all PIC/S Participating Authorities to use a common GMP deficiency classification model. PIC/S should consider developing a PIC/S common GMP deficiency classification model.

Annual reviews. It may be useful to adopt this exercise and discussion on common GMP deficiencies throughout industry at PIC/S level on an annual basis. Data from each PIC/S Participating Authority could be collated for analysis. The collated output may be used to identify common specific GMP areas to be focused on for training and to help pull resources together within PIC/S.


There is a correlation between the most frequent GMP deficiencies classes and the most severe GMP deficiencies classes. This correlation implies that there is harmonization across all PIC/S Participating Authorities.

Hans Smallenbroek is the former PIC/S Chairman and a senior GMP Inspector in The Netherlands with the Health Care Inspectorate. Boon Meow Hoe is a senior GMP Inspector in Singapore with the Health Sciences Authority.

The topic of this article will be presented during the PDA Europe-PIC/S workshop 2012, taking place May 9–10, 2012 in Geneva, Switzerland.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: Pharmaceutical Technology,
Click here