PharmaTutor
1 June 2014

Free drug policy to be streamlined for integration with NHM

(1st June, 2014); Dr Harsh Vardhan, Union Minister for Health and Family Welfare, has asked for thorough streamlining of systems in the distribution of free generic drugs to government health institutions at all levels throughout the country. The Free Drug Programme’s formal launch would be preceded by working out all logistical details with respect to procurement and distribution in consultation with the state governments.

1 June 2014
A REVIEW ON STABILITY GUIDELINES BY ICH AND USFDA GUIDELINES FOR NEW FORMULATION AND DOSAGE FORM

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ABOUT AUTHORS:
Anilkumar S. Chinchole1*, B.N.Poul2, C.V. Panchal1, D.V. Chavan1
1Department of Quality Assurance, Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
2Principal of Maharashtra College of Pharmacy, Nilanga
Maharashtra College of Pharmacy, Nilanga, Latur, Maharashtra, India
*anilc14@gmail.com

ABSTRACT
Stability guidelines for new drug substance and new pharmaceutical formulations as per ICH and USP for the evaluation and consistency for new drug and pharmaceutical dosage form. The brief understanding of these guidelines can be easily recognized by this article. Stability testing Provide a evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. To establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. Because physical, chemical or microbiological changes might impact the efficiency and security of the final product. To minimize the Adverse Effects Of Instability In Drug Products Loss of potency of drug such as Change in concentration of active drug, Alteration of bioavailability, Loss of content uniformity, Loss of pharmaceutical elegance and patient acceptability, Formation of toxic degradation products.