ASEAN – QUALITY REQUIREMENTS FOR GENERIC FILLING
Journal Title: European Journal of Biomedical and Pharmaceutical Sciences - Year 2017, Vol 4, Issue 8
Abstract
ASEANrequires Process Validation report on three consecutive production batches which should include: Summary Introduction Batches used for validation Manufacturing equipment Critical process steps and parameters Acceptance criteria Sampling plan Tabulation of the test results Batch Analysis Evaluation of data Statistical process control analysis Evaluation of data including comparison against Acceptance criteria Discussion on deviations and out of specification results Conclusion and recommendations If Validation report for three consecutive batches is not available then the below said can be submitted:
Authors and Affiliations
Dr. G. Sandhyarani
Keywords
Related Articles
- EP ID EP628994
- DOI -
- Views 147
- Downloads 0
VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD FOR DETERMINATION OF TRIMETAZIDINE IN PHARMACEUTICAL DOSAGE FORMS
A stability-indicating HPLC method was validated for the determination trimetazidine in tablet dosage form. The chromatographic conditions comprised of a 250 X 4.6 mm column containing 5-μm; packing L1 (C18), with a mobi...
THE EVALUATION OF BANDAGE CONTACT LENSES AS A PRIMARY TREATMENT FOR TRAUMATIC CORNEAL ABRASIONS
Background: Corneal abrasions are a common result of eye trauma. Corneal injuries are very common in both the adult and paediatric population and account for a significant proportion of the workload of most emergency dep...
HEALTH OUTCOMES THROUGH WOMEN EMPOWERMENT - A REVIEW OF THE LITERATURE
Women empowerment refers to increasing the educational, economic, political and social empowerment strength of individuals and communities of women. Empowering women and making them to be involved in all the development...
EFFECT OF COMBINED THERMO-TREATED PALM OIL AND GARLIC ON THE LIPID PROFILE OF WISTAR ALBINO RAT
Some dietary fats pose negative effect on the human cardiovascular system. These effects over time have been reported to be preventable using plant extracts. Allium sativum have been found to posses many therapeutic effe...
THE POTENT ROLE OF SMART CHITOSAN NANOPARTICLES ON ATTENUATION OF TESTICULAR DAMAGE CIMETIDIN –INDUCED IN SWISS ALBINO MICE
The present study was carried out to investigate the ameliorative effective of chitosan NPS on testicular damage induced by cimetidine. Mice were randomly divided into 4 groups, the first group served as control group, t...