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2-3. Organisation of Sampling Programmes Background Information. Richard Wanko. Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009. Outline.
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Organisation of Sampling ProgrammesBackground Information
Richard Wanko
Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009
A portion, piece, or segment that is representative of a whole.
In the context of medicines “a portion/piece/segment” means:
x g/ml active pharmaceutical ingredient / excipient / bulk material… or
x units of the finished dosage form (tablet, bottle,…)
representative of a batch
Reference: http://www.thefreedictionary.com/
In the context of medicines:
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
Reference: Eudralex Vol 4 – Medicinal Products for Human and Veterinary Use: GMP, Part II
The act, process, or technique of selecting an appropriate sample.
In the context of quality control of medicines “an appropriate sample” means:
representative sample to evaluate the quality of the whole batch
Reference: http://www.thefreedictionary.com/
provides a sample for analytical testing
A sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned. Where stability permits, reference samples from critical intermediate stages (e.g. those requiring analytical testing and release) or intermediates, that are transported outside of the manufacturer’s control, should be kept.
Reference: EU Guidelines to GMP, Annex 19
Retention sample
provides a specimen of the fully finished product
A sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes. For example, presentation, packaging, labelling, patient information leaflet, batch number, expiry date should the need arise during the shelf life of the batch concerned. There may be exceptional circumstances where this requirement can be met without retention of duplicate samples e.g. where small amounts of a batch are packaged for different markets or in the production of very expensive medicinal products.
Reference: EU Guidelines to GMP, Annex 19
Reference sample
e.g. in cases where Out-of-Specification (OOS) results need to be verified
Retention sample
e.g. in cases where the authenticity of a product needs to be confirmed (e.g. counterfeit identification)
Used in the context of the General European OMCL Network (GEON) in Market Surveillance Studies (MSS). Sample acts as “unifier” and is tested by all participants of a post-marketing surveillance testing campaign (= study covering – as a rule - a group of products on the different national markets) to get an idea about the comparability of performance of the different laboratories.
This term is used in the sampling and testing programme for Centrally Authorised Products (CAPs) of the CAP Network, which is organised jointly by the European Medicines Agency (EMEA) and EDQM. The purpose of the sample is to compare a new, recently released batch with test samples drawn along the distribution chain.
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QC
OMCL
=> Control of legal environment
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=> Investigation in illegal environment
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Bulk material (before packaging)
e.g. assessment of stability during transit / shipment
Drug products (DP)
e.g. follow-up of complain
Packaging material including Patient Information Leaflet (PIL), label etc.
e.g. market surveillance campaign
Processing agents, cleaning agents, compressed gases
e.g. cleaning validation
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Valid Shelf-life Specification
To perform test for compliance in post-marketing situation
Composition of DP
To allow the interpretation of observed impurity profile
(Analytical) method validation data
To support method transfer
Storage conditions for sampled material
To guarantee correct transport and sample storage
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For annual post-marketing working programme
e.g. use of risk-based models considering following aspects
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Example of a risk-based model used by the General European OMCL Network (GEON)
Reference: RB Model for Targeting Medicinal Products for MS Testing, PA/PH/OMCL (07) 87 6R
For annual post-marketing working programme
Sufficient amount of material; if possible from different batches
On basis of selected test parameters
On basis of used test method
To allow ideally more than one full test run and repetitions for a sound statistical evaluation of the results
To enable repeated testing in case of OOS results
To cover a big quality range of the product
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For annual post-marketing working programme
Availability of competence within the OMCL
Sub-contracting to private laboratories should be avoided, if possible
Collaboration with other OMCL should be given priority
Replacement policy for sampled material
Voucher system for replacement of taken samples
Special treatment of orphan drugs (low market volumes)
Nevertheless: sampling plans should be made on scientific grounds and not be driven by budgetary considerations
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Example used in the CAP programme
Storage requirements for samples during shipment and on-site storage
Cold chain – controlled transport with temperature recording (data logger) for unstable products
Light and/or moisture protection, where applicable
Special sampling plan for samples intended for sterility testing
Sufficient number of samples to make a sound statistic evaluation (according to pharmacopoeial requirements)
Time points and location of sampling
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Example used in the CAP programme
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Sampling in warehouses (starting material, intermediates or bulk products):
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Sampling in pharmacies/hospitals/at wholesalers (original sales package):
Sampling via internet:
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Testing complements paperwork and helps to find an answer regarding
but in a strict sense test results alone only allow to draw conclusion for the tested batch(es) and not for the product in total
The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls.
One type of RTR testing. Parametric release is based on process data (e.g. temperature, pressure, time for terminal sterilisation) rather than the testing of a sample for a specific attribute.
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Shift from
Is this the end of classic punctual sampling? or
New challenge for post-marketing sampling and testing?
=>RTR testing is not the end of market surveillance and “classic” sampling will still be necessary
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Thank you for your attention
Dr Richard Wanko
Scientific Officer
Council of Europe
European Directorate for the Quality of Medicines and HealthCare (EDQM)
Biological Standardisation, OMCL Network & HealthCare Department (DBO)
7 alleeKastner, CS 30026
F- 67081 Strasbourg, France
Tel.: + 33 (0) 3 90 21 40 13
Fax: + 33 (0) 3 88 41 27 71
E-mail: richard.wanko@edqm.eu