During an inspection, Swissmedic found a number of GMP deficiencies in the production area. The company concerned has had to suspend production of sterile medicinal products until the necessary corrective actions have been completed. As a result, the supply of some of the medicinal products concerned – which are used primarily in hospitals – may be temporarily disrupted.
Swissmedic inspection uncovers Good Manufacturing Practice (GMP) deficiencies
During an inspection at the end of August 2020, Swissmedic discovered a number of production deficiencies at Legacy Pharmaceuticals Switzerland GmbH, a Swiss contract manufacturer of pharmaceutical products. Swissmedic immediately instituted administrative proceedings to have the company’s manufacturing licence partially suspended and obliged the company to draw up and implement a corrective and preventive action plan (“CAPA”).
Until a follow-up inspection has confirmed that the quality, maintenance and qualification of the plant in question meets GMP requirements, the production and sale of various sterile products have been temporarily halted.
The authorisation holders for the medicinal products concerned have been informed accordingly. Swissmedic has also informed its partner authorities of this matter, as a number of the products are exported.
Possible interruption to supplies
Since production has been halted for the time being, supplies of certain medicinal products that are used mainly in hospitals may be interrupted for an unspecified period. Swissmedic is currently investigating whether individual batches of products on the Swiss market will have to be recalled. In the case of products that are critical in terms of therapeutic applications and/or availability of alternatives, Swissmedic is currently examining whether individual batches – or some of the batches that have already been manufactured – may be released.
In doing so, Swissmedic is bearing in mind that the supply situation for certain medicinal products manufactured by this company may be critical, as well as considering patient safety. Swissmedic will provide information on further developments as soon as it is available.
|15159||Liquemin 25,000 I.U., solution for injection||Treatment and prevention of thromboembolic disease|
|15160||Protamin® Ipex, solution for injection||Inactivation/neutralisation of heparin|
|40467||Ancotil®, solution for infusion 1% (i.v.)||Treatment of mycoses (fungal infections)|