Regulations for clinical trials are strict, as patient well-being and safety are the most important considerations, and companies that do not follow these regulations can be subject to criminal prosecution. Pharmaceutical products for a clinical trial must comply with CGMP standards. Inventory-control activities such as counting, tracing, and product identification must all meet the regulations for the particular type of product. By regulating manufacturing, production, packaging, and storing, CGMP is intended to ensure that all patients are getting pharmaceutical products of the highest quality.
Clinical Trial Packaging Requirements
Most clinical trials use bottles, blisters, pouches, syringes, and tubes. However, sometimes these require modifications. For example, “smart” bottles have been used to increase patient compliance and lead to better trial outcomes. Clinical trials usually have multiple products within the same pack, but the process for making them can differ greatly depending on the volume
Packaging requirements also differ by stage. The use of blister packaging or wallet cards is common for later-phase studies, especially if the patient needs to take two different drugs. Labeling, positioning, and coloring are important because they must be identical so the patients do not notice differences between the drug and the comparator.
Kitting is another important component in the packaging of clinical trials. More complex Phase III trials usually involve a study drug, comparator product, and placebo, in addition to syringes, swabs, and needles, or rescue medications. Each component must be positioned for easy use by the patient, and the packaging must also allow for the inclusion of all necessary components for administration.
Cold Chain Requirements
Temperature-controlled pharmaceuticals present another clinical packaging challenge, as insulation is necessary to maintain the correct temperature for both oral solids and injectables. Some study drugs must be stored or shipped in a cold or frozen state. During shipping, these products must be maintained at a certain temperature, which means the correct type of container must be used. The use of appropriate materials and labels will help to ensure product integrity, patient compliance, and the best possible outcomes for the study. And of course, the work area must have proper lighting, sufficient space, and cooling so that product quality is not compromised.
Deadlines for clinical trials are strict, with a turnaround time of four weeks from award. Therefore, JIT concepts become critical to the labeling and distribution of clinical materials. Packaging must be done quickly and correctly the first time so the clinical trial is not delayed. A packager with experience and adequate fulfillment capabilities is needed to meet this delivery window.
Currently responsible for over 280 pharmaceutical and biotech clinical trials, Complemar’s expertise is unmatched. The company’s facilities are CGMP compliant and FDA registered, so your clinical trial requirements will be completed on time. Packaging can be a driving force in the success of a clinical trial by ensuring patient compliance and adherence to medication regulations. To learn how we can help your clinical trial be successful, please give us a call!