RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 2019 > 1 > EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

Posted 16 January 2019 | By Ana Mulero 

EU Restricts Slovak Manufacturer’s GMP Certificate Over Spate of Deficiencies

Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies.

The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following an inspection conducted last December.

Slovakia’s competent authority concluded that Unimed Pharma’s facility had failed to comply with the EU’s GMP requirements based on the two and 21 critical and major deficiencies, respectively.

The critical deficiencies that were observed during the inspection relate to “pharmaceutical quality management, cross-contamination management and quality assurance management,” according to SIDC. Those deemed as “major” deficiencies “were cited for inadequate documentation management, validation activities and lack of trained personnel,” SIDC added.

EU national competent authorities (NCA) moved to restrict Unimed Pharma’s GMP certificate, as well as recommend a prohibition of supply limited to situations in which there are no alternative suppliers and there is a potential risk of a drug shortage. The actions come as a result of the observed deficiencies.

“If there are alternative suppliers and there is no risk of shortage, recall of medicinal products should be evaluated by involved NCA’s following assessment conducted in conjunction with MAHs [market authorization holders],” said SIDC. “Given the nature of non-compliances, assessment should include a complete retest of all imported batches of medicinal products.”

Statement of Noncompliance with GMP


© 2022 Regulatory Affairs Professionals Society.