International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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This journal is member of Crossref. 

1. Impact of Drug Prices & Drug Price Discrepancies Between Some Countries
D. Krishna Veni, N. Vishal Gupta
Pharmaceutical prices are substantial and are rising faster mainly due to increasing population and increasing cost of new developing pharmaceutical technologies. Drug prices are correlated to income levels. Generic drug manufacturers are able to offer products at lower cost than the branded drugs. Branded drugs are sold at significantly lower prices in least developing countries. Development of innovative pharmaceutical products ensures the continued gains. To encourage the continued development of new drugs, economical incentives are essential. These incentives are provided by the direct or indirect funding of the government. Intellectual property rights and other policies favor innovations. It says that benefit designs, reference pricing and group purchasing will reduce the financial barriers and it keeps down the spending on pharmaceuticals. This article provides empirical evidence on the impact of drug price and drug price discrepancies in some countries

2. Various Criteria in Development & Validation Of HPLC Analytical Methods: Review
J.R.Patil, D G Joshi
HPLC method development and validation play important role in the discovery, development and manufacture of pharmaceutical products. This article mainly focuses on the optimization of HPLC conditions and other important perspectives during method development and validation. Various critical steps related to analytical method development and validation is discussed. A sequence of events required for method development and analytical validation are described. The steps involved in developing a stability-indicating HPLC method influences the analysis of degradation products/impurities in stability study and its validation demonstrate the suitability for its intended purpose

3. Path Finder Process Validation of Dry Heat Sterilizer in Parentral Manufacturing Unit.
R S Kalkotwar, T K Ahire, P B Jadhav,  M B Salve
Sterile products have several unique dosage form properties, such as freedom from microorganisms, freedom from pyrogens, freedom from particulates, and extremely high standards of purity and quality; however, the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. Dry Heat Sterilization method is use for Depyrogenation of Glassware (Ampoule, Vial), Metal Equipment, Heat stable Oils, Ointment, and Powders etc. on based on oxidation of microorganism, Conduction & Convection Method. Equipment utilized to provide the dry heat medium must be validated every half year to ensure the system is able to consistently provide Dehydrogenated or sterile product and meets the quality. Validation should be done by proper planning. The efficiency of any heat treatment is determined by the design and source of the heat. To study must done on Heat distribution, Heat penetration, Bioburden and pyroburden determination and microbial/Endotoxin challenges, Minimize the utility cost and Man hours during sterilization cycle.  An attempt have been done in this project work to consider all the suitable Critical and Variable parameters in regards to Heat Penetration and Least Temperature required for Sterilization and cost saving.

4. Quality Assurance by Effective Manufacturing Process Validation
Kotagiri Ravikanth, Kanaujia Anil, Thakur Deepak, Sharma Anirudh, Harihara Sudheer, Chauhan Abhinay, Thakur UdayVeer Singh, Gautam Bhupesh.
Validation study is the core subject of study in quality assurance field and effective process validation as a part of QbD contributes significantly to assuring product quality. As per ICH Q8 guidelines of pharmaceutical development a critical quality attribute is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. The enormous growth of herbal medicinal products worldwide has been one of the most interesting aspects of healthcare. As pharmacological properties of an herbal formulation depend on phytochemical constituents present therein, it becomes inevitable to incorporate quality by design concept in manufacturing processes to ensure predefined product specifications are met. Development of authentic analytical methods which can reliably profile the phytochemical composition and help in validation of manufacturing process is a major challenge to scientists. Prior standardization of formulation during its designing and development stage with respect to its bioactive marker compounds as a key feature of CQA (critical quality attribute) ensures  the  phytoequivalence during the manufacturing of product on commercial scale. This will ensure the batch to batch consistency in quality & efficacy

Impact Factor: 1.041

UGC approved Journal

This journal is present in UGC approved List of Journals for the purpose of Career Advancement Scheme (CAS) and Direct Recruitment of Teachers and other academic staff as required under the UGC (Minimum Qualifications for Appointment of Teachers and other Academic Staff in Universities and Colleges)

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