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Adarsh Shikshan Prasarak Mandal’s

(Recognized by PCI New Delhi, Approved by DTE Mumbai & Government of Maharashtra Affiliated to Dr. Babasaheb Ambedkar Marathwada University, Chhatrapati Sambhajinagar)

ASPM’s K. T. PATIL COLLEGE OF PHARMACY, OSMANABAD
Pharmaceutical Quality Assurance
The focus areas in Quality Assurance research include analytical method development for estimation of API in bulk and pharmaceutical dosage forms, analytical method validation studies as per ICH guidelines, manufacturing process validation studies (through industrial tie-ups), bio-analytical method development for estimation of drugs in biological specimen (through tie-ups with clinical research centres) and establishing quality control parameters/ standards for herbal drugs as per WHO guidelines. Without assurance that these medicines are relevant to priority health needs and that they meet acceptable standards of quality, safety and efficacy, any health service is evidently compromised. In developing countries considerable administrative and technical effort is directed to ensuring that patients receive effective medicines of good quality. It is crucial to the objective of health for all that a reliable system of medicines control be brought within the reach of every country. The supply of essential medicines of good quality was identified as one of the prerequisites for the delivery of health care. WHO’s Revised Drug Strategy, adopted by the World Health Assembly, identified the effective functioning of national drug regulation and control systems as the only means to assure safety and quality of medicines.Yet the World Health Assembly continues to express great concern about the quality, safety and efficacy of medicines, particularly those products or active pharmaceutical substances imported into, or produced in, developing countries. In recent years counterfeit products have infiltrated certain markets in disquieting proportions. Since the founding of WHO, the World Health Assembly has adopted many resolutions requesting the Organization to develop international standards, recommendations and instruments to assure the quality of medicines, whether produced and traded nationally or internationally.

Quality assurance department is equipped with ultramodern digital apparatus such as:

  • Double Beam UV Spectrophotometer
  • Spectrophotometer
  • Karl Fischer
  • Spectroflouriometer
  • Flame Photometer
  • HPLC
The College