Published on Jun 12, 2024
For pharmaceutical, biotechnology, and medical device products to reach the end user, the patient, without compromising their quality and purity, all components are expected to meet the specified pharmacopeia and quality-related requirements.
It is the responsibility of the license holder to be aware of which manufacturer or supplier produces or supplies these ingredients and to make the necessary follow-ups. The damage that a raw material or component of unknown or suspicious origin may cause to patient health and company reputation may be irreparable.
For this reason, we have to carefully select, monitor, audit, and periodically review the performance of service providers that may directly or indirectly affect product quality, especially the suppliers or manufacturers of raw materials, starting materials, and components.
It is possible to provide all of these activities by qualifying our suppliers. This training will not only address how the qualification process should proceed and the categorization of suppliers, but also the issues of identifying and eliminating risks lurking throughout the supply chain.
Since the Elixir incident, purchasing raw materials, especially those used in pharmaceutical products, from manufacturers or suppliers of unknown origin, or purchasing raw materials from these companies without audit and evaluation, has caused many people to lose their lives.
A similar situation also applies to medical devices. Remember the PIP Breast implant scandal. The scandal arose when PIP decided to replace the main component material used in the production of silicone breast implants with a cheaper, industrial-grade silicone that was not approved by health authorities.
We must carefully plan each phase necessary to complete supplier qualification. Using resources, we must first map our processes and decide what kind of supplier we need for which product production.
At this point, URS should be taken into consideration and if a product or service is to be purchased, the participation of all relevant departments in the evaluation process is very important.
Identifying candidate suppliers and completing the pre-selection process should be subsequent activities. During the pre-selection phase, many parameters such as the past performance of the supplier or manufacturer, whether the service or product has been purchased before, its competitiveness and recognition in the market, its performance in legal authority inspections, especially the FDA, and also its geographical location should be evaluated.
Once the candidate supplier has been identified, it is important to put the pre-qualification processes in order. On-site audit of suppliers, contract manufacturers, and laboratories is one of the most critical stages.
After the evaluation of the trial batches after the audit, stability, and validation, we must mutually sign the quality agreement by determining all responsibilities. After routine shipment or service begins, the monitoring phase should be activated.
Continuous monitoring of suppliers, manufacturers, laboratories, and service providers and evaluating their performance is another important step. While continuing with those with high performance, it would be the best decision to warn those with low performance first and, if they do not meet your criteria, to disqualify them and remove them from the approved supplier list.
Discover more about this fascinating topic in our Best Practices for Supplier Qualification in Life Sciences course
Published on Jun 12, 2024 by Angela Spall