Swissmedic Annual Report 2017: achieving success through collaboration

46 Market access | Licensing
Official Medicines Control Laboratory
(OMCL)
The accredited Swissmedic laboratory is responsible for the
official batch release of stable blood products and vaccines,
and supports the various sectors of Swissmedic by means
of laboratory analysis and method developments and assessments.
Activities
• After almost 10 years, the structure of the OMCL was
analysed and redefined. Official batch release is now
concentrated in one laboratory unit. The remaining
activities have been transferred to two additional
laboratory units. The purpose of this restructuring is
to enhance flexibility and to separate OCABR (Official
Control Authority Batch Release) from laboratory tasks.
The new structure has been operative since 1 May 2017.
• The OMCL is very well networked both nationally
and throughout Europe and plays an active role in
developing and optimising European pharmacopoeial
monographs within various expert groups maintained by
the European Directorate for the Quality of Medicines
(EDQM) and in Swiss expert committees.
• The OMCL collaborates with the EDQM in close consultation
with the Pharmacopoeia Division, its activities
encompassing practical tasks in the laboratory, the
production of draft monographs and their experimental
testing. One focus of this work is the improvement of
chromatographic detection methods for impurities in
pharmaceutically active substances.
• Last year 30 pharmacopoeial requests involving a total
of 280 samples were processed.
• In the year under review, medicines that did not have
an authorisation were analysed for the Penal Division,
Antidoping Switzerland and Market Surveillance. Most
of the work done for Market Surveillance involved
neuro-enhancers, anabolic substances and erectile
stimulants.
• The five-yearly re-accreditation of the OMCL by the
Swiss Accreditation Service in accordance with ISO/IEC
standard 17025:2005 was performed during a three-day
audit in August 2017. The audit confirmed the staff’s
high level of technical skills and identified potential for
optimisation. This external evaluation enables the OMCL
to demonstrate its expertise as a testing centre in the
national and international arena, while at the same time
improving its laboratory work and quality management.
• Batches of plasmatic coagulation factors for the treatment
of haemophilia A and haemophilia B patients were
analysed as part of a market surveillance activity. All the
batches tested complied with the specifications in the
authorisation.