04.06.2019 | LOGFILE Feature 21/2019

An excerpt from the new e-book The Road to a Pharmaceutical Quality System

The aims and basic principles of the PQS

The aims and basic principles of the PQS

4 min. reading time | by Stephanie Blum


Every patient who is ill and takes a medicinal product hopes it is effective and heals the illness or at least alleviates the symptoms.

However, the scandal in the USA in 1937 involving the preparation Elixir Sulfanilamide and causing the deaths of 107 patients, and the Thalidomide disaster at the beginning of the 60s in Germany made it obvious that one thing is more important: medicinal products must be safe. This is why the primary objective of the pharmaceutical quality system (PQS) is patient safety. Chapter 1 of the EU GMP Guidelines stipulates that all holders of a Manufacturing Authorisation must ensure that the manufactured medicinal products

  • are fit for their intended use,
  • comply with the requirements of the Marketing Authorisation or Clinical Trial Authorisation and
  • do not place patients at risk due to inadequate safety, quality or efficacy.).

The final bullet point shows how important patient safety is for the authorities: safety always comes first, followed by the quality and efficacy of the medicinal product.

A number of stakeholders with different tasks work together to achieve this objective: the pharmaceutical company, the drug regulatory authorities and supervisory authorities. During the development of the medicinal product, the pharmaceutical company ensures that it meets the quality requirements before applying to the relevant authority for a marketing authorisation. The regulatory authority reviews the application before making a decision. If it is successful, the marketing authorisation defines the framework for all further activities. As far as the authorities are concerned, the safety of the patient is guaranteed (only) when the medicinal product is manufactured and tested in accordance with the requirements of the marketing authorisation. Only products that meet this requirement may be placed on the market. The authorities must be notified if changes are made that affect the marketing authorisation and, if necessary, the changes must be approved. The supervisory authorities are the third party involved. They carry out regular inspections of the medicinal product manufacturer to check their compliance with the requirements of the marketing authorisation and GMP/GDP.

The medicinal product manufacturer is obliged to implement, maintain and continuously improve a PQS in order to manufacture medicinal products that meet the above-mentioned requirements at all times. The PQS must be comprehensively documented using instructions and records and include all aspects that individually or jointly affect the quality (and safety and efficacy also) of the medicinal product specified in the marketing authorisation. The PQS covers the entire life cycle of the medicinal product from pharmaceutical development through technology transfer to commercial production until the product is discontinued. It also includes the development and monitoring of the internal and external quality-related processes.
It expressly covers all of the processes that are outsourced to contract manufacturers, contract laboratories and other service providers, including all of the interfaces with suppliers, contract givers and customers.

Depending on the size of the company and the number of branches and subsidiaries, the PQS can apply to a single operation or across the group as a whole. Hybrid forms are also common in corporate groups: policies that apply across the group regulate the corporate principles of the quality system and are supplemented by local documents for the individual sites. These implement the global requirements of the company in local instructions.

The most important PQS-related regulatory requirements can be found in Chapter 1 of the EU GMP Guidelines (Pharmaceutical Quality System). The requirements in Chapter 1 of the Guidelines are complemented by ICH Q10 (Pharmaceutical Quality System). ICH Q10 has been incorporated into Part III of the EU GMP Guidelines and includes three important quality objectives:

  • Product Realisation:
    The PQS should allow the manufacture of products with quality attributes that meet the needs of patients, health care professionals and the regulatory authorities.
  • State of Control:
    The manufacturer should establish effective monitoring and control systems in order to provide assurance of continued suitability and capability of the processes.
  • Continual Improvement:
    Because "stagnation means regression", the manufacturer is obliged to identify and implement areas for improvement with regard to company products, processes and systems using current sources of knowledge.

In order to achieve these objectives, the following elements of the PQS are of central importance (see also Figure 1):

  • quality policy and quality planning (see chapter 1.3 Quality policy, quality planning and quality objectives)
  • documentation (see chapter 2 The documentation of the pharmaceutical quality system (PQS))
  • a large selection of tools (see chapter 1.4 PQS tools)
  • suitable and adequate resources, i.e. premises, facilities, equipment and personnel (see chapter 1.2 Resources).

Figure 1 The PQS and its individual elements

This text is an excerpt from the new e-book The Road to a Pharmaceutical Quality System

Stephanie Blum


Stephanie Blum, PhD
Molecular Biologist, Consultant
E-Mail: stephanie.blum@cirQum.de

The Road to a Pharmaceutical Quality System

The US FDA and the EU adopted ICH Q10 for good reason: The lifecycle approach to drug GMP promises to improve quality across the board. And the primary objective of a pharmaceutical quality system (PQS) is patient safety.

This e-book helps you bring your drug manufacturing quality systems into compliance.

The Road to a Phamaceutical Quality System walks you step by step through the processes and procedures you’ll need to put in place.

Here’s what you’ll learn:

  • What are the key elements of the PQS?
  • What roles do quality policy and quality planning play?
  • What are the responsibilities of management?
  • How are the regulatory requirements implemented in practice?
  • What is the significance of documentation for the PQS?
  • Is a PQS documentation hierarchy necessary (documentation pyramid)?
  • What GMP documentation does a pharmaceutical company need?
  • What is a quality manual and how is it created?
  • Why is a management review carried out and what does it involve?
  • How are suitable key performance indicators defined?
  • What results does a management review deliver and how are they evaluated?

> More information and order