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 impor-tant: 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
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:
In order to achieve these objectives, the following elements of the PQS are of central importance (see also Figure 1):
Figure 1 The PQS and its individual elements
Stephanie Blum, PhD
This text is an excerpt from the new e-book 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: