The pharmaceutical industry is responsible for developing, manufacturing, and distributing life-saving medicines, making it one of the most complex and highly regulated sectors.  However, the industry constantly faces challenges, including product quality, regulatory compliance, and customer satisfaction concerns. To overcome these challenges and ensure the safety and efficacy of their products, pharmaceutical companies need to implement a well-designed and fit-for-purpose quality management system (QMS).

We sometimes get approached by new clients looking for licence authorisations to allow them to enter new markets or change their business model and expand into new types of pharmaceutical operations.  There are usually different authorisations required, and before any application can be made, the QMS and organisational structures need to be put in place for each one, as well as an inspection completed by the competent authority in the country of operation.

A Quality Management System (QMS) is the first step, which comprises all of the policies, processes, and procedures (SOPs) to guarantee consistent and high-quality production of pharmaceuticals. A Quality Management System (QMS) should be tailored to the unique requirements of the pharmaceutical company and regulatory standards. It must encompass all product lifecycle stages, including research, development, manufacturing, distribution, and post-marketing surveillance. 

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A good QMS will help achieve the following important objectives:

  • Ensure that products manufactured or distributed according to the QMS meets all identity, strength, purity, and stability requirements.
  • To comply with the relevant laws and regulations that govern the pharmaceutical industry, such as FDA 21 CFR Part 210 in the US and Eudralex Volume 4 in the EU.
  • To continuously monitor, evaluate, and improve the performance and effectiveness of the QMS.

There are some dos and don’ts when writing a pharmaceutical QMS that will ensure the organisation’s success once licencing is obtained and the QMS is used.

The first and most important thing is to clearly define the scope and objectives of the QMS and align them with the organisation’s business goals and regulatory requirements.  The easiest way to do this is to meet with everyone likely involved in each new process and thoroughly map out the desired method, including responsibilities, objectives and critical tasks or steps. This will then ensure that the SOP will broadly match the expectations of the most critical stakeholders.

It’s essential to create document templates for each document type and utilise built-in styles and formats to ensure consistency and readability. It’s also recommended to use clear and accurate language, avoiding jargon, abbreviations, or acronyms that may not be familiar to all readers.

It is also essential to avoid using redundant or unnecessary language in the written procedures. Additionally, it is essential to avoid using vague or ambiguous terms such as “as appropriate”, “as needed”, or “where possible”, which may lead to confusion or inconsistency in implementing the QMS.  Better to use “shall”, “will”, or “must”.

The next step is to implement the QMS processes and then monitor and measure the QMS performance to verify the effectiveness and efficiency of the QMS processes. Typically, this will be through ongoing management review and metrics evaluation, as well as internal audits to verify the conformity and compliance of the QMS processes. The organisation must compare the actual performance of the QMS processes with the expected performance based on established quality objectives or an annual quality plan. They also need to identify gaps, weaknesses, or opportunities for improvement in the QMS processes.

Finally, there should be mechanisms for continuous improvement; typically, this will require implementing robust corrective actions or preventive actions (CAPA) to address any gaps or potential nonconformities in the QMS processes. The pharmaceutical organisation must implement improvement actions to enhance the QMS processes based on feedback, suggestions, and best practices.

A well-designed and fit-for-purpose QMS is essential for the pharmaceutical industry to ensure the quality of its products and the safety of its customers.  A well-designed Quality Management System (QMS) should encompass all business processes, personnel duties, and standards, including manuals, policies, and procedures. This system guarantees that regulated operations are conducted in a controlled manner, resulting in the production of safe, effective, and high-quality products. At Orion GXP Consulting, we collaborate with clients to create customised QMS documentation that caters to their proposed facilities, products, and business processes. Afterwards, we follow up to ensure that the written procedures are properly trained and implemented at their manufacturing and distribution facilities for optimal performance.

Orion GXP Consulting has developed pharmaceutical Quality Management Systems for our many satisfied clients, from small virtual wholesalers to large pharma multinationals. If you would like to chat about your QMS or licensing requirements, please reach out.

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