Where Can Normec Advipro Make a Difference? | PIC/S Standard

As the head hospital pharmacist, you are responsible for the quality system of your services. A key task is to minimize all potential risks and mitigate them where necessary. To gain a clear overview of these risks and the corresponding strategies, a risk assessment is typically performed. In Annex I – General Principles and Guidelines, the following is stated: "Where necessary, processes are supported by risk assessments to ensure their safety and relevance." These assessments are carried out in accordance with the principles of the ICH Guideline Q9 on Risk Management. The primary purpose of performing such an analysis is clear: to reduce risks and ensure safety. The secondary benefit may be less obvious, but is equally important. A well-executed risk assessment not only identifies which mitigation strategies are necessary, but also which ones are unnecessary — thereby ensuring relevance. While applying every possible risk-mitigation strategy may feel safe, an overload of measures can lead to an expensive and time-consuming quality system that may not be applied sustainably in the long run.

In addition to our in-depth expertise in conducting risk assessments within GMP environments (traditional pharmaceutical industry), Advipro is also experienced in carrying out assessments for hospital pharmacies (GPP) and in the context of cross-contamination. Although the core principles are the same, the emphasis may differ. Just like with the development of a URS, support in a risk assessment can range from facilitating the process to full delivery of the finalized document.

As previously described, work is carried out in controlled environments and with controlled processes. Naturally, it must also be demonstrated that these spaces and processes remain continuously under control. This is achieved through the validation of the installation (IQ), operation (OQ), and performance of the system or process (PQ). Normec Advipro has a team of Mobile Validation Experts (MoVE) who come to your cleanroom with state-of-the-art equipment and perform all necessary tests to demonstrate that the cleanroom, laminar airflow unit, biosafety cabinet, or isolator meets the required classification. In addition, they can also validate your sterile processes and equipment, such as the sterilization cycle of an autoclave. Support for your validations can range from providing only the results of practical tests to developing test methods and delivering the complete package of sampling plans, protocols, results, reports, and conclusions. The expertise and support during the execution of the tests are, of course, included as standard.

In the pharmaceutical industry, the choice of software is quickly made, as it must always comply with "Title 21 CFR Part 11 (FDA): Regulations on electronic records and electronic signatures." In a GPP environment, this strict regulation is not yet required, but the current standard is still high, and several requirements are outlined in the PIC/S, including the following:

• Access to the registered data is restricted to individuals designated by the hospital pharmacist-in-charge – it is therefore important to establish proper user management.

• The hospital pharmacy has a sufficient information system tailored to its activities and is secured. The system is user-friendly and supports the management of the hospital pharmacy and the execution and monitoring of pharmaceutical care. A procedure outlines the access and permissions for managing the system.

• Automatic backup of critical data.

• Training for users on the software in use.

• Electronic records must be properly protected against unauthorized alterations and data loss. The readability of electronically stored data must be ensured for the entire retention period.

• If electronic documents are used, the integrity of the data must be ensured. Documents must be retrievable in a timely manner, and there must be adequate access control in place.

Advipro can also play a role in the selection and validation of software. Based on a URS and a risk assessment, the necessary protocols, tests, and reports can also be written and executed for software.

Each party has its own knowledge and expertise, and that’s a good thing. However, we often find that not all expertise is equally valued during the tendering process. Everything related to writing procedures and protocols, validation, and quality management is less tangible and visible than the construction of the cleanroom, and therefore sometimes gets overlooked. Of course, validation or a quality management system is something that should not be compromised, as it directly impacts patient safety. It’s important to consider this from the start of the project. Input and feedback from an expert from the tendering stage will lead to various savings by the end of the project, both financially and in terms of meeting the delivery date.

During the construction of a new cleanroom or hospital pharmacy, the current team of pharmacists and staff is primarily relied upon. Naturally, they are most familiar with the processes and will also be the end users, so their input is invaluable. However, it’s important to realise that the current operations of the pharmacy will not come to a halt. In the best case, some time may be made available for certain individuals to work specifically on the new project, but we often find that the amount that can be delivered in that time is overestimated.

If you work in a hospital, you may be encountering these stricter regulations for the first time. With Normec Advipro, you bring on board a partner that has already supported several Flemish (university) hospitals in their projects. Templates for various documents are ready to start your project. Additionally, we can rely on a team of nearly 150 project engineers with expertise in pharmaceuticals and biotechnology. When needed, their expertise can be applied to your project. Finally, our Mobile Validation Experts interact daily with regulated or sterile environments and have procedures ready to test and validate them.