Swissmedic ramps up ad hoc inspections in 2015

By Phil Taylor

- Last updated on GMT


Related tags: Pharmaceutical drug, Pharmacology

The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

The total number of Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) inspections carried out by Swissmedic and four regional Cantonal Inspectorates fell from 617 in 2014 to 565 last year.

'For cause' inspections for complaints or infringements accounted for 18% of the total number of inspections, according to the regulator, which attributed the increase to more intensive enforcement of company monitoring.

"Since quality problems are often indicative of systemic (GXP) problems, Swissmedic intensified ad hoc inspections in response to complaints or suspected infringement of the law…in order to clarify shortcomings of this type on the spot and request corrective action​" says the annual report​.

Meanwhile, after a brief interruption in 2014, Swissmedic was once again involved in inspection programmes organized by overseas regulators.

Four active pharmaceutical ingredient (API) manufacturers - two in India and two in China - were inspected in collaboration with the European Directorate for the Quality of Medicines & HealthCare (EDQM) and a blood transfusion service in Indonesia was inspected with the World Health Organization (WHO).  

Swissmedic also saw a higher number of foreign regulators conducting inspections within Switzerland.  All told, 58 inspections took place, including 24 from the US food and Drug Administration (FDA), eight from South Korean regulator, five from Turkey and three apiece from Brazil, Kazakhstan and Kenya.

Quality defects up, recalls down

Swissmedic also received 679 reports of quality defects in medicinal products, a 10% increase on 2014, although the number of batch recalls fell to 28 from 32 in the prior year.

Among the incidents reported in 2015 was one medicinal product which had to be recalled down to the patient level because of the risk of skin irritation, burns or inflammation.

Another incident involved a concentrated hand disinfection product was incorrectly packaged with the patient information for a product containing the same active ingredient but sold as a ready-to-use product diluted by a factor of about 20.

Two different dosage strengths of one product were thought to have been mixed up, while another case involved capsules with unknown contents, which led to a recall down to the retail level.

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