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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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!