The term “audit” has been coming up very frequently lately. Recently, we underwent an audit ourselves as part of renewing our ISO 9001 certificate. We also regularly welcome customers conducting their own audits, and in turn, we carry out audits on (new) suppliers. Essentially, an audit is a check to ensure that processes run smoothly and that we meet the required quality standards. Although this may sound simple, in practice it is often more complex. In this blog, I will shed more light on this process.
We serve a wide range of (bio)pharmaceutical customers, many of whom have a quality officer or even an entire department responsible for adhering to the many regulations involved in developing and manufacturing medicine. This is understandable, given that these products are administered directly to people, often to those who are ill. Therefore, preventing contamination or pollution is crucial, and the entire production chain - from raw material to end product - is subjected to extremely strict controls.
Audits in collaboration with our assembly and transport partners
At Hitma, we contribute to this process by supplying high-quality single-use components and assemblies for medication production. We do not manufacture these components ourselves; instead, we source them from various suppliers. In this process, we work closely with our assembly partner, UltraPure International (UPI), which converts these components into ready-to-use assemblies.
To ensure that our operations are well-organized and that we meet the requirements of our (bio)pharmaceutical customers, they may perform an audit at our company. Since both our assembly partner UPI and our transport partner APG Europe are located near our headquarters, they can be visited and inspected in one session.
How does the Hitma audit process go?
At Hitma, I, Esther Koornneef, serve as the quality coordinator and the main point of contact for planning an audit. I am responsible for organizing the presence of the quality staff from both UPI and APG so that they can answer any questions. I myself can provide further information about, for example, the certificates that accompany all our products. These certificates contain important details such as the batch the product belongs to, the production date, and approval by the manufacturer. In the event of any complaints, we can quickly identify the relevant batch using these certificates and pass this information on to the manufacturer to identify any defects and prevent future issues.
During the audit, one has the opportunity to inspect the cleanrooms and warehouses at UPI. In the UPI warehouse, the flows of goods moving in and out of the cleanroom are strictly separated by means of a color-coded system. In the cleanrooms, the relevant procedures (SOPs) that operators follow are explained to ensure that only the correct components are assembled in accordance with the specifications defined in the assembly drawing and the bill of materials (BOM). These procedures detail how to properly place, secure, and package the components. Often, operators are present to demonstrate the process in person.
Once the assemblies are completed, they are inspected again by UPI’s quality staff and then transferred to the APG warehouse. All of this can be checked during the audit, so visitors can see for themselves whether everything is carried out according to the specified procedures.
In the APG warehouse, the products are prepared for shipment, either to the customer or to another party in the Netherlands for further processing, such as irradiation. APG staff can demonstrate how they handle the logistics of incoming and outgoing transport, again paying close attention to separating the different incoming and outgoing product flows. The APG warehouse also receives the individual components from both Hitma and UPI, which are then labeled with a unique Hitma or UPI product code and stored in the designated areas before being picked for a specific order. Accuracy is of the utmost importance here to ensure that the correct procedures are followed.
Although it may sound straightforward, a great deal is involved in procuring and distributing single-use components and assemblies. We warmly invite customers to come and see these processes for themselves, as we are proud of the high-quality products we deliver together. Moreover, our customers’ questions help keep us sharp and often contribute to improvements in our procedures.
Do you want to know more, or are you interested in an audit at Hitma, UPI, and APG? Feel free to contact me!