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
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