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Company Organisational Structure

Here is a quick breakdown of the different department within a pharmaceutical company.

Research & Development

Can be involved with the initial discovery of active molecules that will go on to be the basis for new medications. Also often work on known molecules and formulations to make them optimal or on development processes to streamline.

Regulatory Affairs

Management of the applications to all relevant regulatory bodies for the authority to develop, produce and market pharmaceutical products. These applications are submitted at specific times once all supporting evidence has been gathered and there is sufficient proof of concept to support progression through the product lifecycle. They also manage the required ‘in house’ regulatory documentation in line with legal requirements.

Quality Control

Quality check all product to ensure in line with necessary standards. This can be checking products supplied in to the company from elsewhere, checking intermediary stages of pharmaceutical product or checking the finished batches of product. These checks are carried out using laboratory equipment and are carefully documented – this documentation is then stored as proof of these checking measures. Such rigorous testing and documentation is required to ensure that products reaching the marketplace are safe.

Validation

Members of this department work to assess all equipment and processes to ensure that everything matches or exceed both internal quality requirements but also external legal and regulatory requirements. Documentation of this assessment is a key part of the roles within this department and is stored as proof of compliance. Validation occurs at every stage throughout the production process, individuals within this area often work with a particular niche of validation (e.g. equipment validation or process validation).

Production (Process)

Deal with all stages of pharmaceutical product manufacture – from producing active ingredients, through to completion of finished products and even packaging. Due to this diversity, work in this area can take many forms and involve the use of specialist machinery. These production processes are all carried out in strict adherence to both internal and external protocols.

Quality Assurance

This department is responsible for developing all internal quality protocols – ensuring that they meet or exceed the minimum standards set at national or international levels. Each batch of finished product must be signed off by the Qualified Person within the QA department, the paperwork collected by Quality Control throughout the production process is used to support this signing off process.

The size of these departments depend upon the size of the pharmaceutical company (smaller companies may outsource some of these roles altogether) but they are all ultimately critical parts of the pharmaceutical manufacturing process.