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STANDARD OPERATING PROCEDURE FOR PROCESS VALIDATION

STANDARD OPERATING PROCEDURE FOR PROCESS VALIDATION 1.0       OBJECTIVE To establish scientific documented evidence that process is consistent delivering the intended performance of the product. 2.0       SCOPE This SOP shall applicable to all the new process developed in-house or transferred from …

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Process Validation through New Guideline

Process Validation through New Guideline There are three stages of process validation through new guideline process design, process qualification, and continuous process verification. And four types of process validation are Prospective validation, Concurrent validation, Retrospective validation, and Re-validation. Here what …

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Most asked Quality Assurance Interview questions and answers

Most frequent questions asked in Quality Assurance Interview Pharmaceuticals Q1. What is change control? Types of change control Answer:  When a change is being made in any process or procedure it is reported by change control procedure and that is approved by the company …

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ICH Quality Guidelines for Pharmaceutical updated Aug 2020

ICH Quality Guidelines from Q1 to Q14 Q1A    Stability testing of new drug substances and products Q1B    Stability testing: Photostability testing of new drug substances and products Q1C    Stability testing for new dosage forms Q1D    Bracketing and matrixing designs for …

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