18.10.2023 | LOGFILE Feature 39/2023

Organisation of Quality Assurance

Organisation of Quality Assurance

5 min. reading time | by Thomas Peither

When we take a drug, we first and foremost want it to work – to cure an illness or at least alleviate its symptoms.

There is another thing we tacitly assume today: We assume that medicinal products and their quality are safe. And quality assurance is responsible for this.

This has not always been the case. After the sulphanilamide tragedy in the USA in the 1930s, which killed 107 people, and number of other high-profile incidents, a lot has happened in the last 100 years. Today, quality assurance is an important task in pharmaceutical companies.

Chapter 1 of the EU GMP Guide requires every holder of a manufacturing authorisation to manufacture medicinal products in such a way that patients are not exposed to risks due to inadequate safety, quality or efficacy.

A number of parties work together to achieve this objective: the pharmaceutical company, the regulatory authority and the supervisory authorities. On the part of the pharmaceutical company, in addition to correspondingly careful development work, seamless quality control is also required. Internal quality assurance plays a central role in this.

Who is responsible for the establishment and functioning of the Pharmaceutical Quality System (PQS)?

Describing the tasks and hierarchical integration of quality assurance within a company is anything but trivial. Neither the EU GMP Guide Part I nor FDA 21 CFR Parts 210 and 211 define quality assurance as an organisational unit.Although there are few mandatory requirements, certain standard structures have become established over time. However, whether these must be implemented – as is sometimes almost dogmatically demanded – must be critically questioned.

I am thinking in particular of small and medium-sized companies that do not have functions based on a high degree of division of labour. In any case, the supposed specifications are only to a limited extend based on real requirements from authorities. So the good news is that nothing is set in stone.

Each company can choose the organisation of quality assurance that best suits its processes and requirements. It's like clothing – one size doesn’t fit it all – size, colour and cut are all individual choices. You ‘tailor‘ a system to fit.To this end, it is helpful to briefly outline the regulatory requirements for the organisation of the quality function:

Both the EU GMP Guide and FDA 21 CFR Parts 210 and 211 mention and require only one quality organisation unit in the company.


FDA 21 CFR 210.3 (Definitions)

FDA 21 CFR 211.22 (Responsibilities of quality control unit)
FDA Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
EU GMP Guide Part I, Chapter 2 (Personnel)

For this Quality Control Unit, the above regulations require strict independence from production is required. Its responsibilities are described more comprehensively in the FDA regulations than in the EU GMP Guide. This is because 21 CFR 211, unlike the European guidance, does not recognise any responsibility of production or manufacturing for GMP compliance in their area. The Quality Control Unit therefore has much more responsibility for documentation and GMP compliance in production.

How the FDA envisages a split between quality control and quality assurance functions is described in the Guidance for Industry ‘Quality Systems Approach to Pharmaceutical CGMP Regulations‘. However, in a politically astute move, it does not specify a particular organisation, but refers to the current state of the art. This leaves much room for interpretation.

The EU GMP Guide reflects in its description of tasks the system of responsibilities for the Head of Quality Control, the Head of Production and the Qualified Person that has been in place since 1965.

Over the years, it has been supplemented by a list of tasks to be performed jointly by the Head of Production and the Head of Quality Control. Finally, in 2014, a passage was added stating that, depending on the size and structure of a company, a Head of Quality Assurance or Head of the Quality Unit can be designated. If this is the case, the responsibilities of the other functionaries must of course be reassigned.

But be careful: What cannot be inferred from this description is any authority to issue directives or even any kind of supervision of the Head of Quality Assurance over the other two key positions.

And that is a good thing. Responsibility for the establishment and operation of the PQS is clearly regulated: It is the pharmaceutical company who decides how the requirements for the pharmaceutical quality system and the design of the quality organisation are implemented.

As I mentioned it at the beginning, one size doesn’t fit it all.

You can also study the 21 CFR 210 and 211 specifications as often as you like. In the case of a two-part Quality Control Unit – i.e. devided into QC (Quality Control) and QA (Quality Assurance) – it cannot be inferred that QA is authorised to give instructions or is superior, unless you confuse QC with a pure laboratory organisation.

This often seems to be the case, as QC is often described as a production unit that produces analytical results. There is no question that quality control must have sufficient laboratories and laboratory capacity according to EU GMP Guide and 21 CFR 211. However, its tasks are much broader. It includes, for example, checking the environmental conditions and the manufacturing documentation.

Only Part II of the EU GMP Guide for Active Pharmaceutical Ingredients recognises a QA unit as an organisational unit that should be independent of production. However, this unit is also primarily responsible for QA and QC tasks.

If a company decides to divide the tasks of the quality function into a QC and a QA unit, it is important to clearly define the tasks and responsibilities. This is the only way to ensure that all relevant aspects are covered and to avoid counterproductive redundancies.

This article is a shortened and translated excerpt from the 37th episode of our German GMP & TEA webcast.

Thomas Peither


Thomas Peither
GMP expert, specialised GMP journalist and founder of the GMP publishing house - GMP-Verlag Peither AG
E-Mail: thomas.peither@gmp-publishing.com

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