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 558
- Downloads 65
NEW SPECTROPHOTOMETRIC DETERMINATION OF LAMOTRIGINE IN BULK AND PHARMACEUTICAL DOSAGE FORM
The new, selective and sensitive visible spectrophotometric method have been developed for the estimation of Lamotrigine in bulk and in pharmaceutical preparations. The amino group in lamotrigine is diazotized with sodiu...
CURRENT SCENARIO OF PHARMACOVIGILANCE IN INDIA
Even though Pharmacovigilance is still in its infancy in India, it is not new to India and still there exists very limited knowledge about the discipline. While major advancements of the discipline of pharmacovigilance h...
A RECENT APPROACH FOR SOLUBILITY AND BIOAVAILABILITY ENHANCEMENT: SOLID DISPERSION
Currently only about 8% of the new molecules have both high solubility and permeability. The drugs therapeutic efficacy depends upon the bioavailability and ultimately upon the solubility. Improving oral bioavailability...
A NOVAL TRANSDERMAL DRUG DELIVERY SYSTEM AND ITS POSSIBLE EVALUTATION: A REVIEW
A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. The human skin is a readily accessible surface for drug del...
PHOSPHOLIPASE A2 IN AIRWAY DISEASES: TARGET FOR DRUG DISCOVERY
Importance of the Field: Inflammatory airway diseases are on the rise world over. There is need for orally active, safe and efficacious antiinflammatory agent. Existing therapeutic options are plagued by poor efficacy an...