Product quality and product safety

ESG | 3 min read
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As a worldwide market leader in pharmaceutical compounding, Fagron applies a strict product quality and safety policy. If a product does not meet all quality specifications, it can cause side effects on end users. Therefore, product quality and safety are a priority for Fagron.

Goals and objectives

We aim to deliver products that meet all product quality and safety requirements. A good indicator of this goal is the number of product recalls in one year. In a few exceptional cases, products must be recalled because they do not meet all quality specifications. We divided the recall of products into three categories.

  • Class I concerns a recall for products that can cause severe injury;
  • Class II concerns recalls for products that can cause temporary side effects;
  • Class III concerns products that are unlikely to cause injury or illness but do not (fully) meet GMP (Good Manufacturing Practice) standards.

Fagron’s quality process

Supplier selection procedure

An extensive supplier selection procedure ensures traceability of the more than 2,500 pharmaceutical raw materials that Fagron uses. New suppliers are screened extensively. Quality documents and manufacturing documents are saved with the help of a software application that is accessible to all companies in the Fagron Group. Suppliers of products with a higher risk profile are subjected to an on-site audit. These audits focus primarily on the quality and safety of the product.

Incoming products

All pharmaceutical raw materials that arrive at one of our compounding and repackaging locations are tested by quality technicians to guarantee that they meet all applicable laws and regulations, requirements, and internal standards.

Manufacturing

Fagron has 34 compounding and repackaging facilities worldwide (2021) that fully comply with GMP (Good Manufacturing Practice) or comparable local laws. This concerns a combination of certified facilities and facilities where an audit is carried out regularly by the authorities by GMP standards and legislation.

International certifications such as GMP and GDP require that all employees who come into contact with pharmaceutical products must attend several annual training courses on product quality and safety. Training on standard operating procedures (SOPs) in most of our repackaging and sterile production facilities happens via the MasterControl software. Each month more than 7000 training tasks are being completed. Each user, on average, completes two training tasks per week. A training task could, for example, be learning about a new cleaning procedure of products before they enter a clean production environment.

Released products

Final products in our sterile and non-sterile compounding facilities are by quality technicians to ensure that they meet all quality specifications. The majority (approximately 2/3rd) of the pharmaceutical products that we supply from our repackaging and compounding facilities are tested in-house in one of our own quality laboratories before they are released; an (external) third party tests the rest (approximately 1/3rd).

Tracking quality events

The quality events in most of our repackaging and sterile production facilities are registered via MasterControl. This means we have a clear overview of complaints, audit recommendations, deviations from quality procedures, and other quality events. The process for reviewing the quality event and preventing quality events from happening in the future is also tracked in MasterControl.

You can know more about Fagron quality here.