PCI, a global supplier of pharmaceutical commercial packaging solutions and clinical trials services, announces the availability of a white paper detailing the advantages of having on-site analytical laboratories in order to meet the needs of the pharmaceutical industry. The white paper is available to download via PCI On-Site Analytical Laboratories White Paper and discusses the challenges and implications of having off-site laboratories, and how the construction of on-site laboratories can make the analysis, packaging, development and commercialisation of medicines more efficient.
Analytical laboratories have a responsibility to successfully execute qualitative and quantitative analysis on potential drug discoveries. They also have an important role in the clinical trial process, providing the pharmaceutical industry with the necessary data during the drug development process. However, over the past few years the industry has faced numerous challenges with off-site analytical laboratories; including, geographical and financial implications, time constraints and the use of unfamiliar in-house staff. The pharmaceutical industry now recognises the need to have on-site analytical laboratories to monitor both the process internally, whilst accelerating the process without affecting the quality or knowledge applied.
The process of testing and packaging is a vital part in developing a new clinical drug, yet it can be time consuming, geographically difficult and expensive for the company involved. Analytical testing laboratories which are situated off-site, whether overseas or not, create a huge boundary that needs to be overcome to improve efficiency. They also create a physical distance between the testing site and the key personnel who oversee the laboratory’s facilities. As a result, this process can increase turnaround time.
In addition, when selecting a laboratory, a pharmaceutical company must dedicate time to research the laboratory provider and determine if they meet the necessary regulatory requirements, including their past success rate in a particular therapy area. This process can be extremely resource-intensive, in terms of commitment, time and money. This preventable delay in communication has an impact on the entire production process, ultimately postponing the final release date.
Many of the challenges mentioned above can be resolved with the introduction of on-site analytical laboratories. One of the main benefits of having analytical laboratories on-site is that they can be tailor-made to each company’s individual requirements, and needs; from layout, design and equipment to the staff hired to work in the laboratory. This allows a manufacturer closer, direct access and insight into the entire process and the results, something which is essential to any manufacturer.
The speed at which results are processed and generated can be significantly improved by having an on-site analytical laboratory. The primary advantage is that the investigators can react to data in real time, as it is generated. The rapid production of results improves efficiency and productivity of the drug development process.
For more information on PCI and its services, please email [email protected] call +44 (0) 1497 820829 or visit www.pciservices.com.
About Packaging Coordinators, Inc.
Packaging Coordinators, Inc. offers unparalleled expertise in a range of proprietary pharmaceutical and biotechnology packaging innovations for healthcare clients across all markets. PCI leads the field in providing cutting-edge customized healthcare packaging solutions that improve patient adherence and uphold the most stringent safety requirements. For more information about PCI and its state of the art facilities in the USA and Europe, please visit the company’s website at www.pciservices.com