Immunization standards

Laboratory Quality Systems

Course on Laboratory Quality Systems (LQS) at the National Institute for Biological Standards and Control (NIBSC), UK

NIBSC was established in 1972 and is a designated WHO laboratory for biological standards. The purpose of NIBSC is to safeguard and enhance public health through the control and standardization of biological substances used in medicine. NIBSC is the National Control Laboratory for the UK and is also one of the Official Medicines Control Laboratories (OMCL), in the EU, for biological medicines (including vaccines, blood products and immunoglobulins). Within Europe, each batch of these licensed medicines needs to be submitted to an OMCL for examination. Products which are in compliance with the Product Licence (Market Authorization) receive a Release Certificate enabling the sale or supply of the batch. The biologicals testing work of NIBSC is accredited to meet the requirements to the EN45001/ISO Guide 25. These are the technical quality standards for testing laboratories. The operation of a technical quality system will improve the quality and reliability of control work.

Course overview

The biologicals testing work of NIBSC is accredited to meet the requirements of the International Standard BS EN ISO/IEC 17025, the technical quality standard for testing laboratories and the course is based around this standard.

The aim of the Laboratory Quality System course is the teach participants about the need for a Quality System in National Control Laboratories and demonstrate how documentation and monitoring of procedures can help to ensure the quality of biological medicines used within their countries.

This course has been certified by a WHO Expert Review Committee, indicating that it meets the aims and objectives of the Global Training Network on Vaccine Quality.

Courses run twice a year and last for 4 weeks. Trainees will receive lectures and participate in open discussion sessions with key NIBSC staff.

The course will involve tutorials on key aspects of technical quality systems, including:

  • The role of a National Control Laboratory (NCL) in lot release.
  • Organisation of an NCL and Responsibilities of key staff.
  • The need for a Quality System.
  • Key documentation: the Quality Manual, Study Plans and Standard Operating Procedure. Archiving.
  • Controlling and managing change.
  • The role of internal audits and reviews.
  • Equipment commissioning and maintenance /calibration.
  • Review of manufacturers test data, including final product and constituent test data – WHO requirements.
  • Receipt, handling and storage of test items.
  • Training of test operators and objective assessment of their competence to undertake testing.
  • Key steps in implementing a Quality System.
  • Use of appropriate biological reference materials.
  • Statistical analysis of tests and bio-assays.
  • Test validation (pharmacopoeial, in house methods).
  • Monitoring of test and operator, to ensure continued satisfactory performance.
  • Repeat testing – when is it undertaken?
  • Comparison of manufacturer’s data with NCL test data.

Participants will spend time in our laboratories which perform batch release on biological medicines, to see how the quality system functions but the course is not designed to teach practical aspects of vaccine testing.

We have successfully trained scientists from many countries in all aspects of a Quality System suitable for a testing laboratory. Feedback from past trainees suggests that they have been able to make significant improvements to their working practises and environments, even where resources have been limited. Trainees have stressed the benefit of their attendance on the LQS course.

Further information please contact:

Dr A Sasiak, Training and Development Coordinator
NIBSC, Blanche Lane
South Mimms, Potters Bar
Hertfordshire, EN6 3QG, UK
Fax: + 44 (0) 1707 646 730 Email: asasiak@nibsc.ac.uk

Dr Umit Kartoglü
GTN/VQ Coordinator
World Health Organization
IVB/QSS
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: 41 22 791 4972
Fax: 41 22 791 4384
Email: kartogluu@who.int