laboratory activities market surveillance · 2018. 7. 3. · adviser - quality manager deputy head...
TRANSCRIPT
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Laboratory ActivitiesMarket Surveillance
Katrin Kollist
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Outline of the presentation
1. Quality control – Sampling programme
for analytical control
2. International Cooperation
3. Quality Assurance
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1. Quality control – Sampling programme
for analytical control
2. International Cooperation
3. Quality Assurance
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The structure of Quality Control
Laboratory
Management
Executive staff
Head of Laboratory
Adviser - Quality Manager
Deputy Head of Laboratory
AnalystsChief specialistsAssistant
Adviser
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People
Alltogether in the lab 9 persons, filling 8 positions
Management and supportive activitiesHead of Department
Deputy Head of Department
Quality Manager
Documentation and archiving
Analysis of Manufactured medicinesChief specialist and 3 analystsAnalysis of magistral preparations
Chief specialist and Assistant – dealing part-time with analysis
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1. Sampling programme for analyticalcontrol
Main types of analyses:
• Medicines with marketing authorisation in Estonia
and the medicines in the process of getting
marketing authorisation ~50
•Medicines with single marketing authorisation ~40
•Other analysis (magistral preparations and purified
water, suspicios samples etc.) ~310
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The main principles of compiling detailed analysis plan (I)
• Medicines with single import authorisation
• NRP Medicines: statistics of usage, new generics,
information about quality defects, veterinary
medicines
• Medicines of Estonian producers with MA
• GMP compliance of Estonian producers finished
products and raw materials
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• Inspections
• Suspicious samples (complaints, borderline
products etc.)
• Magistral preparations and purified water – decree
of the Ministry of Social Affairs
• MRP/DCP Medicines: collaboration within OMCL
Network
• CAP Medicines: central control procedure
coordinated by EMA/EDQM
Annual plan is a living document
The main principles of compiling a detailed analysis plan (II)
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Analysisplan
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Statistics
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OOS
Laboratory work process
Analysisreport
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Samples analysed in 2011
Medicines without
MA; 32
International; 19
Suspicious
samples;13
Medicines with
MA; 69
Purified water; 53
Magistral
preparations;
232
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Main Activities of Estonian OMCL
1. Quality control – Sampling programme
for analytical control
2. International Cooperation
3. Quality Assurance
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OMCL Network I
A Network of Official Medicines Control
Laboratories of the member states that have signed
the European Pharmacopoeia Convention or
countries that are observers to the European
Pharmacopoeia Commission
The laboratory of State Agency is a member of the
Network since 1998.
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OMCL Network II
Activities within the OMCL Network:
activities that are open to all the member and
observer states of the European Convention on the
Elaboration of a European Pharmacopoeia.
•Quality Assurance programme
•MSS - Market Surveillance Studies
•PTS - Proficiency Testing Scheme studies
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OMCL Network III
Activities involving Member States of the European
Union (EU) and the European Economic Area
(EEA) and Switzerland where appropriate:
•Participation in analysing the CAP-Centrally
Authorised Products
•Participation in MRP/DCP Mutually recognised
products, Decentralised products scheme
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• Participation in European Pharmacopoeia
Commission and expert group (P4)
• Verification of new monographs
• Participation in collaborative trials for elaboration
of CRS
Pharmacopoeial Activities
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1. Quality control – Sampling programme
for analytical control
2. International Cooperation
3. Quality Assurance
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Quality Assurance in the Laboratory
Quality system according to ISO17025
• Quality Manual and SOPs
• Traceability
• Quality control of the results
• Competent personnel, responsibilities stated
• Internal and external audits
• Management reviews
• Proficiency testing
Continous improvement
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Accreditation by Estonian Centre of Accreditation
since 2009
Mutual Joint Audits of the OMCL Network
2007 Initial Audit
2011 Reassessment audit
External Assessments
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Thank you!