Pharmaceutical manufacturers have to upgrade their quality testing facilities on a regular basis based on current regulatory requirements. To meet the basic criteria of safety, quality and efficacy, Quality testing for raw materials, in-process materials and final products besides packing materials is part of any regulatory requirements.
With increased conscious of patients, technology and regulatory requirements current challenge of cluster firm is not to estimate the purity of the active material, but to assess the content of impurities. To estimate this level of concentrations, the cost of analytical equipment will be very high and in many cases it is not in the reach of pharma SMEs. As per Schedule ‘M’ regulations it is expected that entrepreneur has to create all such facilities to test the quality of incoming, in-process and final product besides packing materials. Costs of such facilities are very high and number of laboratory giving. Such benefits are limits. Common testing laboratories on suitable packages to finance private laboratory promotion of the proposed common laboratory MPPMO may be done. |