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As China has become the fastest-growing market in generic drugs, China Food and Drug Administration (CFDA) is paying more attention to drug quality and setting a higher standard for pharmaceutical packaging. Compatibility of the drug with the packaging materials is one critical focus area.
Now China is experiencing a change from Registration System to Bundling Review, and there is greater emphasis on the drug manufacturers to provide a more comprehensive evaluation regarding the suitability of the packaging materials with the drug products. CFDA has published Compatibility of Chemicals and Elastomer Closures in the China Draft Technical Guideline (CTG), which details the requirements for extractables and leachables (E&L) studies.
As E&L is a critical subject for domestic drug manufacturers, many of them would have the following questions on how to proceed:
West proposes the above roadmap and can provide further support as needed, both in the design of experiments, and the performance of experiments by West Analytical Laboratory Services. Contact your Account Manager or Technical Customer Support (TCS) representative for more.
Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).
The process of crimping an aluminum seal onto a pre-stoppered vial should not be overlooked or underemphasized. Within the pharmaceutical industry, there is a need for an elegant and effective seal not only from the cosmetic perspective, but also more importantly, because of the correlation between seal quality and container closure integrity. Even in laboratory settings and during early-stage evaluations of a drug product and containment system, reliable, robust and consistent crimped seals are necessary.
Leaders in the pharmaceutical industry are expecting rapid growth in the near future. To proactively equip the company for these changes, West recently organized a Leaders Round Table in Ahmedabad, India.
West’s Ambassador Interns in Exton assisted the local West Chester Food Cupboard’s move into their new, larger facility. They packed and loaded 80,000 pounds of food at the Food Cupboard’s previous site, and then moved the supplies to the new facility. The West Chester Food Cupboard’s move enables the organization to serve even more clients, and was made possible through the Ambassador Interns’ help.
On October 20, West and President & CEO, Eric M. Green, were recognized as a Health Care Innovator by the <em>Philadelphia Business Journal</em>.
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