Validating shortage annexes

To view the Component Listings / Hand Receipts listed below, you must: 1. Maintaining the supply of global products can involve complex challenges for the industry.

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A third had experienced Shortages on their own manufacturing sites. Referring to Figure 5 - of those that returned the survey the major contributory factors two fifths reported quality problems related to non-compliances during drug manufacture and just over a third commented on poor audit outcomes followed by a third due to non-compliance with the MA.

Question 6What should be done by the government to prevent drug shortages in the future (asked in 6 questions)?

Referring to Figure 6 - of those that had returned the survey nearly half commented that regulators needed to have a closer dialogue with the manufacturers, just greater than a third suggested to have a list of alternative manufacturing sites in the event of an issue.

Just over a third also reported that there is a need for a EU wide database to formally notify authorities of Drug Shortages and a third reported the need to establish additional manufacturing capacity should be established within the EU.

Referring to Figure 2., approximately three quarters of those that returned the survey manufactured Drug Products and the remaining fifth are equally split between the manufacture of API/Excipients and Others (refer to Figure 3. Question 3 Has your company experienced any problems with Drug Shortages in the past 3 years or do you think there is a high likelihood that this will happen in future? lack of availability of APIs for your products, serious quality defects of finished products, GMP non-compliance resulting in ability to release products etc.).

Last modified 04-Jun-2020 19:07