Moldova. Distribution and Quality Control in the Pharmaceutical Market

Distribution

The main gap is the lack of GDP which threatens the maintenance of medicines’ quality during the distribution process. Although the country is planning to introduce GDP guidelines, these have not yet been approved. Further, there are no SOPs for stock management at each level of the distribution system and it is unknown to what extent the requirements mentioned in the law are implemented at the warehouse level.

Quality control

Issues related to the use of quality control rather than quality assurance measures have caused delays in availability of medicines because every imported batch had to be tested (which is not necessary and causes work overload for the laboratory). Further, SOPs for quality control are largely not available and a quality policy for the laboratory is missing. Another important gap is the lack of a strong and well-functioning post-marketing quality control system.

Positive development

The country has recently taken some very initial, yet promising, first steps in moving towards a risk-assessment and quality assurance system with the introduction of a new order on quality control of medicines. With the new order, medicines registered by companies from the EU, Australia, Japan, Canada or the USA are tested on a random basis (previously all first ten batches). For medicines registered by companies from a country other than EU, Australia, Japan, Canada, or USA but compliant with national GMP, all the first five batches are tested (previously all first ten batches). If the company passes all these first five tests, all following tests are done on random (but not risk assessment) basis. For manufacturers which are not compliant with GMP, all batches are tested, not only the first five. Transition to quality assurance should hopefully help avoid delays in the future.

Source: Journal of Pharmaceutical Policy and Practice