Improving Knowledge Base On Pharmaceutical Quality Assurance, December 4-11, 2009

news2CAPS implemented a course on EU Guidelines of Good Distribution Practice for Medicinal Products. The training, conducted in collaboration with the newly established GXP Center of Excellence, was led by international consultant Dr. Michael Kimber. Twenty-two representatives of Armenian drug manufacturing and distributor companies, the Scientific Center for Drug and Medical Technology Expertise, the Ministry of Health and the National Institute of Health took part in the training. The course aimed to build capacity within individual companies to establish a distribution and supply chain quality assurance system in order that patients receive quality medicines, in compliance with EU GDP requirements.

On December 9-11, Michael Kimber conducted a course on GMP Workplace Assessments. Twelve participants of the GMP Training course, implemented in May-June 2009, took part in the training, intended to create a core group of assessors capable of assessing in-company GMP training courses and trainers. The GMP Trainers will develop their own in-house training programs and assessment documents, based upon standardized criteria.

Feedback from course participants was favorable: ‘We have received an accurate understanding of how to perform workplace assessments’; ‘I have got in-depth awareness of the importance and methods of assessment’; ‘This has been a great chance to improve our knowledge of the right organization of storage and distribution of medicinal products and of making the right decision in extreme situations’.

The newly created GXP Center of Excellence (CoE) acted as a partner in organizing both training courses, namely, in the promotion, recruitment and selection of participants. Both courses contributed to an improved knowledge base on pharmaceutical quality assurance and enhanced capacity of the CoE, established with CAPS assistance.