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General Aspects of Quality assessment of multisource interchangeable medicines. Rutendo Kuwana Technical Officer, WHO, Geneva. Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009. Topics. Principles of assessment Quality by design (QbD)
General Aspects of Quality assessment of multisource interchangeable medicines
Technical Officer, WHO, Geneva
Training workshop: Assessment of Interchangeable Multisource Medicines, Kenya, August 2009
The assessors should bear in mind the general principles that the applicant,
- primary strategy is to develop a generic using reverse engineering of the innovator
- Data from these studies used to generate the target profile for the generic manufacturer.
Collaboration between assessors and inspectors should be established from dossier submission and during the life cycle of the product
Systematic approach to development that uses predefined objectives with emphasis on product and process understanding and control, based on sound science and quality risk.
Ref: ICHQ8 (R1)
Based on information submitted or available with the applicant/Manufacturer on the level of development (scientific understanding) achieved the assessors or regulatory authority may:
Comprehensive Pharmaceutical Development leads to release of a product with
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.
Working within the design space is not considered as a change. Movement outside of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.
ICH Q8 (R1)
Multidimensional combination and interaction of input variables/process parameters demonstrated to provide assurance of quality (multivariate analysis)
: operating ranges
Y = Time
Z = Water
A management system that directs and controls a pharmaceutical company with regard to quality
It calls for a continuous improvement of Process Performance and Product Quality
Extracted from ICH Q10
Quality is based on a sound combination of science (enhanced scientific knowledge), use of risk management tools and the establishment of an efficient Quality System