INDUSTRIAL PROCESS VALIDATION: A REVIEW
Journal Title: Journal of Drug Discovery and Therapeutics - Year 2013, Vol 1, Issue 7
Abstract
Validation is defined in the supplementary information section of the Federal Register as “a QA function that helps ensure drug product quality by providing documented evidence that the manufacturing process consistently does what it purports to do [1]. Process validation provides a higher degree of assurance that the manufacturing process consistently meets the pre-determined specifications and the quality products output can be used to increase purity. . It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practice and other regulatory requirements.
Authors and Affiliations
Vipin Kumar*| Department of Pharmaceutics, Rayat Institute of Pharmacy, Rail Majra S.B.S Nagar, Punjab, India, A. C. Rana| Department of Pharmacology, Rayat Institute of Pharmacy, Rail Majra S.B.S Nagar, Punjab, India, Rajni Bala| Department of Pharmaceutics, Rayat Institute of Pharmacy, Rail Majra S.B.S Nagar, Punjab, India
Keywords
Related Articles
- EP ID EP1434
- DOI -
- Views 563
- Downloads 65
SYNTHESIS AND CHARECTERIZATION OF PHARMACEUTICAL POLYMERS IN ALKALINE MEDIUM FOR CONTROLLED DRUG DELIVERY SYSTEM
The aim was to synthesized pH dependent polymers in different monomeric ratio, which were intended to be used for controlled drug delivery system. In this study we took monomers which were previously synthesized. i.e. Me...
COMPARING THE EFFECT OF DUAL AND TRIPLE ANTIPLATELET THERAPY ON HIGH SENSITIVITY C-REACTIVE PROTEIN LEVELS IN PATIENTS WITH CORONARY ARTERY DISEASE.
Inflammation is widely considered to be an important contributing factor of the pathophysiology of Coronary Artery Disease (CAD), and the inflammatory cascade is particularly important in the atherosclerotic process. Hen...
Survey on salt iodine content at household level of Chidambaram, Cuddalore district, Tamilnadu
Around 43% of the population does not consume adequate amounts of iodine which make them vulnerable to physical and mental disorder. UNICEF estimates that less than 20% of households in the developing world were using io...
MUCOADHESIVE DRUG DELIVERY SYSTEM: A REVIEW
Mucoadhesive drug delivery systems interact with the mucus layer covering the mucosal epithelial surface, and mucin molecules and increase the residence time of the dosage form at the site of absorption. The drugs which...
PREVALENCE OF AmpC β LACTAMASES IN NON-FERMENTING GRAM NEGATIVE BACILLI FROM CLINICAL ISOLATES.
Background and Objectives: Non fermenting gram negative bacilli (NFGNB) producing AmpC β lactamases an increasing cause of concern in the hospitals as they produce a therapeutic dilemma for the treating physician.The pre...