Managing Staff Training And GMP Compliance - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Managing Staff Training And GMP Compliance
A case study is presented that describes how a software control system can ease the complex task of managing training needs across an international company, and improve GMP compliance by ensuring that employees are aptly qualified to perform their assigned tasks.

Pharmaceutical Technology Europe
Volume 22, Issue 12

The reporting system

A reporting system provides oversight of all training required and performed. One of the reports most frequently needed by management is the evaluation of training of one specific document; for example, to verify if all persons who need to be trained in a certain SOP have already been trained in the current version of the SOP. This functionality may seem basic, but it is extremely helpful in providing an overview about the training status of specific jobs, mapped with job profiles. Roche established such a matrix with an integrated Pharmschul report, which is a graphical list where compliance and (hopefully no) gaps are visible at a glance. The actual training status of employees is automatically reported periodically to management, providing line managers with transparent information of their responsibility in ensuring personnel are trained accordingly. We have found that this information has led to a high status of compliance.

A KPI report for the higher management is also regularly used. Our higher level management forces the monitoring of KPIs, with all employees having a dedicated amount of training to be performed per defined period. The ratio between the total number of trainings, and the planned/required training has to be reported regularly, and helps to justify adequate resources for the technical and GxP training of staff.


Managing GMP training is a complex task, particularly in large companies where Excel spreadsheets and certificate archives are not feasible. Because of this, Roche implemented a professional GMP training system that helps to identify and evaluate training needs, and assign these to each individual in the company. Only with a complete system in place can large companies ensure that every employee receives the necessary information and training.


1. ECA Foundation, FDA Warning Letter Report (2010).

2. U. Schaffer and O. Schmidt, Die Pharmazeutische Industrie, 68(10), 1149–1152 (2006).


blog comments powered by Disqus
LCGC E-mail Newsletters

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

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology Europe,
Click here