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Every year, on November 11, countries from around the globe celebrate Veterans Day to honor the brave men and women who have served in the military.
Veterans Day, also known as Armistice Day or Remembrance Day, is observed throughout many of the 52 countries that are a part of the Commonwealth, a political association of mostly former territories of the British Empire. Some countries included are Australia, the United States, Canada, New Zealand, South Africa, Sri Lanka, India and the United Kingdom.
Veterans Day celebrates military servicemen and servicewomen from generations past, welcomes a new generation of veteran’s home from deployment, and thanks our future veterans who are still serving at home and abroad.
This holiday is celebrated in various ways around the world. Australia, along with several other countries who are part of the Commonwealth, observe two-minutes of silence at 11 a.m. every November 11. The United Kingdom honors veterans by pinning poppy flowers—a symbol for the blood shed of war—to their coats and jackets. The United States often has an official wreath-laying ceremony at the Tomb of the Unknowns in Arlington National Cemetery, while parades and other celebrations are held in other states around the country.
At West, we are especially proud to honor the many veterans with whom we work. The Company recruits veterans in the United States and aims to foster engagement among employee veterans. The recruitment effort—The Ties to Stripes—identifies veteran’s unique skills and offers assistance in transitioning from military life to careers that align with these capabilities and interests. To learn more about Ties to Stripes, visit our website.
Thank you to our veterans and their families for the sacrifices you make in service of country.
<span>Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.</span>
<p>Demand is increasing for Daikyo’s sterile, ready to use closure components, known as Daikyo RUV® (Ready to Use Validated) components. Against that background, Daikyo has significantly expanded its packaging component sterilization operations to meet the needs of smaller customers as well as large scale pharmaceutical companies. By adopting an approach that replicates its existing footprint, Daikyo has been able to manage validation risks effectively, while meeting an ambitious timeline for bringing on new autoclave capacity. The result of this expansion is a state-of-the-art facility that triples the company’s previous sterilization capacity.</p>
The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products<sup>1</sup>. FDA Draft Guidances<sup>2, 3</sup> help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
<span style="color: #000000;">Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity.</span>
On August 6 and 7, 2019, USP hosted the Second Annual Workshop to explore current trends, initiatives and regulations for quality compounding. Members of the West Pharmaceutical Services, Inc. (West) Scientific Affairs and Strategic Marketing departments participated in the USP workshop and gained valuable insight into the key elements of the FDA’s efforts to improve the quality of compounded drugs.
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