Ensuring the quality control of health products while respecting their time-to-market. Pharmaceutical quality and reliability for therapeutic effectiveness.
Training objectives
- Use, with their appropriate meaning, concepts such as: quality assurance, quality management, standards, frameworks, quality audit, etc.
- Know and apply frameworks and standards such as ISO 17025, WHO prequalification, etc.
- Know and apply the process of validation, verification and transfer of analytical methods.
- Know and carry out the process of equipment qualification and calibration and procedure verification.
- Carry out the management of reference substances.
Programme
Use the key concepts appropriately — quality assurance; quality management; standards; frameworks; quality audit; inspection; risks; prequalification; monitoring; qualification; accreditation; certification; process; procedure.
Know and apply the good-practice frameworks and standards of national quality-control laboratories (NQCLs) — ISO 9001/2008 standards; ISO 17025 (2005) standards; WHO prequalification.
Know and apply the process of validation, verification and transfer of analytical methods — requirements for verifying pharmacopoeia methods and methods validated by another institution (manufacturer’s methods); verification of methods and parameters that must be verified; expected differences between verification by the national QCL and by independent commercial QCLs or manufacturers; applicability of the principles set out in the WHO technology-transfer guidelines (section 6); design of method transfer from the manufacturer to the contracted QCL, buyers or national QCL; situations and changes that trigger the revalidation of analytical methods.
Know and carry out the process of equipment qualification and calibration and procedure verification — definition of the terms qualification, verification, calibration and their essential differences; qualification / verification / calibration requirements for the QCL’s key equipment; expectations when national requirements are less stringent than WHO or international ones; definition of preventive maintenance and its frequency; the need for a logbook and its recording.
Carry out the management of reference substances — information accompanying secondary standards / working standards received by a QCL; labelling and records to be maintained; the “new test / monitoring” (including the retention-time study) expected of the received reference substance; frequency of use of pharmacopoeia / primary reference substances and retest possibility.
Know and apply change control in health-product analysis laboratories — parameters that may modify the control system (SOP, form, record, etc.) and elements to be implemented by the QCL; the requirement for a change-control register or other possible approaches; implications of changes in validated and registered pharmacopoeia or manufacturer methods.
Know and carry out investigations in the event of deviations (OOS / OOT) — SOPs on OOS / OOT investigations; application of statistical analysis of results, retesting (who, when, how many), handling of extreme values; principles for communicating and invalidating results during the investigation; keeping records and monitoring OOS / OOT trends by national and commercial QCLs; purpose of monitoring OOS / OOT trends.
Teaching method and learning techniques
Teaching method: interrogative and discovery-based method.
Learning techniques:
- case studies;
- individual and group exercises;
- field activities: technical site visits;
- the trainers involved have experience in the field of medicines management.
Participatory teaching takes into account each participant’s experience. For greater effectiveness, the pedagogical approach is concrete, participatory and encourages exchange. Technical input is enriched by shared discussions and analyses based on real situations. The intervention methodology aims to build specific tools and methods, shared by each professional and based on the needs identified throughout the support.
Contact and registration
Pharmaceutical Expertise and Training Division — CHMP
For any information or registration for this training course:
- Phone: +33 (0)4 73 98 24 81
- Email: contact@chmp.org
- Address: 13 rue des 4 Passeports, 63100 Clermont-Ferrand, France
You can also write to us via the Contact page.