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Quality Management System

Quality Management System

What is a Quality Management System in pharma?

A Quality Management System (commonly abbreviated as QMS) is a collection of documents that aims to attain a quality objective. A Quality Management System is referred to as a Pharmaceutical Quality System (PQS) in the WHO and EU GMP regulatory guidelines.

Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice.

Purpose of a Quality Management System in pharma

Why do pharmaceutical companies need a Quality Management System? To achieve the production or distribution of medicine at constant and pharmaceutical quality you must ensure consistency and traceability.

When repairing an airplane, mechanics follow strict protocols, log every change and check everything twice. Not because they’re bad mechanics, you just want to be sure that the result is always correct, leaving nothing to chance.

Humans make mistakes

Where humans are involved, mistakes will be made. Statistics suggest that, regardless of the task, humans make between 3 to 6 mistakes per hour. A study performed on licensed aircraft maintenance engineers showed that procedure shortcuts, memory lapses and unclassified behaviour accounted for 48% of all maintenance errors. While technical failures (e.g. equipment not working) accounted for only 5%.

Department of Transport and Regional Services Australian Transport Safety Bureau

To make sure that humans make as little mistakes as possible we need to make sure that they can follow a risk-based quality system, designed to minimize errors and attain the quality objective.

So that when something does go wrong, we can quickly and accurately assess what went wrong, why it went wrong, what the severity of the error is, and how to fix it as quickly as possible. With the ultimate goal of ensuring patient safety.

Quality systems in the GMP and GDP regulatory guidelines

Each major regulatory framework has a chapter on pharmaceutical quality systems. It is usually one of the first requirements you come accross when you start to read the GMP or GDP guidelines.

  • WHO good manufacturing practices for pharmaceutical products: Main principles – Annex 2, WHO Technical Report Series 986, 2014
  • EudraLex Volume IV Part 1 – Chapter 1 Pharmaceutical Quality System
  • U.S. FDA – Title 21–food And Drugs Chapter I–food And Drug Administration Department Of Health And Human Services Subchapter C – Drugs: General

Regulatory references to Quality Management Systems

Jaap Koster
Jaap Koster

Jaap Koster has 39 years of experience in the pharmaceutical industry in North- and South America, Asia, Africa and Europe. Jaap is the CEO of PCS.

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