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GMP LOGFILE Features

2018-11-28

LOGFILE No. 44/2018 – What is quality management?

What is quality management?

An excerpt from the GMP Fundamentals

5 minutes reading time

by Christine Oechslein, PhD

 

Why is it necessary to "manage" quality?

The quality of a medicinal product cannot be left to chance, but must be the result of carefully planned actions. The sequence "planning, acting, evaluating, improving" is referred to as "management".

The four most important principles of GMP are derived from it:

  1. Every process and every task is described in detail in specification documents (e.g. work instructions, SOPs, checklists).
  2. Every employee (including managers) carries out the work exactly as defined and reports any deviation immediately.
  3. The employee records everything in detail while carrying out the tasks so that it is possible at a later stage to identify the who, what, and when of something that happened or was observed.
  4. At regular intervals, the results are compared and evaluated to determine if there are trends or high occurrences of problems (review, trending). If this is the case, the work processes and specifications must be improved before a quality error occurs (continual improvement process, CIP).

QC/QA– QM/QMS: What is the difference?

The terms quality control (QC), quality assurance (QA), quality management (QM) and quality management system (QMS) are frequently not sufficiently differentiated in daily use. Unfortunately, there are no clear differentiations or definitions in the legislation. Therefore, it is advisable to define these terms within a company and use them consistently. Any person who works with contractors should ask twice when something is not clear to avoid misunderstanding!

Quality Control

In Germany, quality control normally refers to the department that is responsible for carrying out quality testing of raw materials and products. It is also referred to as analysis, quality testing or control laboratory. In the UK and USA, quality control (QC) usually refers to more than just analysis. For this reason, Quality Control departments in American companies often carry out tasks that fall under quality assurance or quality management in Germany, e.g. the approval of specifications or the release of raw materials and products.

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Figure 1 GMP-QM-QA-QC

Quality Assurance

Quality assurance (QA) refers to all measures that are carried out to ensure the quality of a product or service. This involves more than just quality testing of the product. It includes, for example, the approval of SOPs and specifications for the product, deviation management, supplier qualification, process validation, batch record review, and the QA measures to be used for the actual product or service. This is described in the QA or QM system.

Quality Management

All planned measures that not only affect the quality of an individual product, but serve to improve processes and services across the board, are referred to as quality management. These measures include quality planning, the continual improvement process (CIP), documentation and self-inspection, and the activities of the executive board (e.g. the definition of quality objectives and management review).

In the regulatory requirements, the terms QM and QA are often used synonymously. QM is used more frequently than QA at the present time.

The departments responsible for quality assurance and management can be named as quality assurance (QA), quality management (QM), quality unit (QU) or in another appropriate way.

Quality management system

Everything that is done in a company to ensure the quality of products or services and cross-product quality management must be defined and documented in a quality management system. The terms quality assurance system and pharmaceutical quality system (PQS) are also used.

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LOGFILE-44-What-Is-Quality-Management.pdf

Author:

Christine Oechslein, PhD
Pharmacist
GMP-Praxis, Bad Säckingen
E-mail: c.oechslein@gmp-praxis.de


Source:

This text is an excerpt from the GMP Fundamentals

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previous acquired knowledge.

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Some topics are:

  • GMP: Purpose and basic pharmaceutical terms
  • Laws, licenses and inspections
  • Personnel: Responsibility and hygiene
  • Standard Operating Procedures (SOP) and documentation
  • Design of rooms and facilities
  • Processing and packaging
  • Quality control and market release
  • Suppliers, storage and logistics (Good Distribution Practice = GDP)
  • Alphabetical index and abbreviations

Using practical examples and comparisons to every-day life will help to easily understand GMP regulations.

GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

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