Strengthening the Pharmaceutical Sector in Nepal with QI
Training-of-trainers seminar on analytical method validation for pharmaceutical analysis
What can be done to strengthen local pharmaceutical production in Nepal and enhance added value? Finding answers to this question is the aim of an ongoing project called Support to Nepal in the field of quality infrastructure. Since 2013, PTB has been working with the Association of Pharmaceutical Producers of Nepal (APPON) and the government’s Department of Drug Administration (DDA) to confront the broad range of quality challenges faced by the pharmaceutical sector in Nepal.
One key element of this project’s efforts is to offer tailored, specialized seminars on a regular basis. Each year, PTB helps organize several such seminars, which are attracting a large and steadily growing number of attendees from across the country. The seminars held to date have covered a great number of important topics of high priority for Nepalese pharmaceutical production. These include quality risk management, bioequivalence testing, the production of registration dossiers, reference standards, good manufacturing practices and associated inspections, supplier validation and cleaning validation.
For the recently held virtual training seminar, the subject of analytical method validation for pharmaceutical analysis was assigned top priority by the DDA and by APPON and its member companies. This seminar took place from 30 August to 3 September and was actively attended by 150 employees representing 45 Nepalese pharmaceutical companies. Besides picking up theoretical knowledge, the participants and instructors also gained practical experience working with the drug Fexofenadine HCL, an antihistamine that is often associated with analytical problems. This was followed by an extensive question and answer session at which the trainers from India’s Stabicon company opened up their vast store of knowledge by answering some 200 questions posed by the attendees from Nepal. We are very pleased to say that the seminar was successfully organized and conducted and was very well received by the attendees.
As a special service for its member companies, APPON has produced a brochure containing all of the materials from the training-of-trainers seminar as well as a checklist with frequently asked questions relating to analytical method validation.
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