VALIDATION AND PROCESS DEVELOPMENT: A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 1
Abstract
Total Quality Management and specifications according to regulatory guidelines involved in pharmaceutical production has a great impact significantly on the quality of the products. The validation protocol includes inventory control and equipment inspections in the preliminary steps and in-process controls in the subsequent steps. Process controls are mandatory in good manufacturing practices (GMP). The purpose of setting validation parameters is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it1,2. Thus validation is an integral part of quality assurance. This review critically evaluates the need for pharmaceutical validation, the various approaches and steps involved, and other pertinent considerations.
Authors and Affiliations
Brajendra Rajpoot
Keywords
Related Articles
- EP ID EP145440
- DOI -
- Views 106
- Downloads 0
THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM (BCS): PRESENT STATUS AND FUTURE PROSPECTIVES
The Biopharmaceutical classification system (BCS) was introduced By Amidon et al., (1995) as a method for classifying drug substances based on their dose/solubility ratio and intestinal permeability. It allows predicting...
STUDIES ON ANTIMICROBIAL ACTIVITY AND PHYTOCHEMICAL ANALYSIS OF CITRUS FRUIT JUICES AGAINST SELECTED ENTERIC PATHOGENS
The present study was carried out to find out the antimicrobial activity and phytochemical study of citrus fruit juices viz. Lemon (Citrus limon) and Orange (Citrus ourantium) against medically important selected enteric...
A NOVEL APPROACH OF BILAYER TABLET TECHNOLOGY: A REVIEW
Over the past 30 years as the expense and complications involved in marketing new drug entities have increased, with concomitant recognition of the therapeutic advantages of controlled drug delivery, greater attention ha...
ANTIOXIDANT MUSHROOMS: A REVIEW
The antioxidant properties of wild mushrooms have been extensively studied and many antioxidant compounds such as phenolic compounds, tocopherols, ascorbic acid, and carotenoids identified. The various antioxidant mechan...
FORMULATION AND EVALUATION OF SUSTAINED RELEASE LIQUISOLID TABLETS OF METOPROLOL SUCCINATE
Liquisolid technique is the novel concept of drug delivery via the oral route. This technique is applied to poorly water soluble, water insoluble or liphophilic drugs. According to the new formulation method of liquisoli...