WHAT IS A QMS (Quality Management System)?

The Importance of a Healthy and Compliant QMS

A quality management system (QMS) is a set of policies, procedures and processes that aim to ensure that the quality and integrity of products and services are maintained throughout their lifecycle. 

A QMS is based on the principles of customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management.

In the pharmaceutical industry, a QMS is essential to comply with the regulatory requirements and standards for the manufacture, distribution and supply of medicinal products for human use. A QMS covers all aspects of the pharmaceutical supply chain, from the sourcing of raw materials to the delivery of finished products to the end users. A QMS also ensures that any risks or deviations are identified, assessed, controlled and corrected in a timely manner.

Regulations and the QMS

The main regulatory framework for QMS in the pharmaceutical industry in the UK is the Human Medicines Regulations 2012 (HMRs), which implement the EU legislation on medicines in the UK. The HMRs provide a legal basis for the authorisation, manufacture, importation, distribution, sale and supply of medicines. They also contain provisions to prevent the entry of counterfeit and falsified medicines into the legal supply chain.

The HMRs refer to several EU guidelines that establish the specific requirements of QMS for different activities in the pharmaceutical supply chain.

These include:

• “The Guidelines on Good Manufacturing Practice (GMP) of medicinal products for human use”, which describe the minimum standards that a manufacturer must meet to ensure that the products are of high quality and do not pose any risk to the patients or users. It describes the minimum standards that a wholesale distributor must meet, to ensure that the quality and integrity of medicines are maintained throughout the distribution network.
• “The Guidelines on principles of GDP for active substances for medicinal products for human use”, which describe the minimum standards that a distributor of active substances must meet to ensure that they are sourced, stored and transported in accordance with their quality specifications.

Keep Your QMS Healthy

A QMS should be designed, implemented, maintained and improved according to the specific needs and objectives of each organisation. A QMS should also be documented, reviewed and audited regularly to verify its effectiveness and compliance. A QMS should be supported by adequate resources, competent personnel, appropriate equipment and facilities, and reliable information systems.

The Benefits of a QMS

A QMS, or a quality management system, is a set of policies, procedures and processes that aim to ensure that the quality and integrity of products and services are maintained throughout their lifecycle. A QMS can offer many benefits to an organisation, such as:

• Operational consistency: A QMS helps to standardise the operations of an organisation, so that everyone involved in the process knows what needs to be done and how to do it. This reduces ambiguity, confusion and errors, and improves the reliability and efficiency of the output.
  

• Improved productivity: A QMS helps to improve the effectiveness and performance of employees and processes, by providing clear guidelines, standards and objectives. This enables people to work together towards achieving consistent results, and to measure and monitor their progress.

• Reduced costs: A reduced risk of costly mistakes and rework, by establishing mechanisms for identifying, assessing, controlling and correcting any deviations or non-conformities in the process. This saves time and money, and enhances customer satisfaction.

• Better service delivery: A QMS helps to create a culture of customer focus and quality awareness, by ensuring that the products and services meet or exceed the customer requirements and expectations. This improves customer loyalty, retention and referrals.

• Enhanced reputation: It helps to build a strong reputation for an organisation, by demonstrating its commitment to quality and excellence. A QMS can also help an organisation achieve certification or accreditation from recognised bodies, such as ISO 9001 or 13485, which can increase its credibility and competitiveness in the market.

A QMS is a vital tool for ensuring quality and safety in the pharmaceutical industry. By following the regulatory requirements and guidelines, complying with the best practices and seeking professional guidance from experts like Paradigm Shift Consulting Ltd, we can help ensure that the medicines we use are safe, effective and authentic.

Further Assistance and Support

If you require assistance, advice or a formal consultation, call us on 0330 133 0920 for a free initial 5 minute chat. Alternatively, you can email us at info@ukgdpassociation.co.uk or use the contact form at the foot of the page.

 

Below is a short list of useful links to material associated with this subject.

EU GDP Guidelines (2013/C 343/01) - chapter 1

ISO 9001:2015 ( QMS overview)

GDP Training Website

What Is A Responsible Person (RP)?

Why Management Reviews Are Important

12 Responsibilities for the RP