Procedure for Sampling in Process Validation

Procedure for Sampling in Process Validation

📋 Procedure for Sampling in Process Validation 1. Preparation Stage Review the approved Process Validation Protocol for sampling details (points, number of samples, method). Ensure that sampling tools and containers are clean, calibrated, and labeled. Train personnel...
Possible Causes of Out of Specification

Possible Causes of Out of Specification

Possible Causes of OOS Results 1. Laboratory Errors Improper sample preparation or dilution Incorrect weighing or pipetting Instrument malfunction or improper calibration Wrong method execution or deviation from SOP Calculation or transcription errors 2....
Tips to Develop Equipment Cleaning Procedure

Tips to Develop Equipment Cleaning Procedure

✅ Tips to Develop Equipment Cleaning Procedure Risk Assessment First Identify the potential for cross-contamination, product carryover, and microbial risks. Classify equipment as product-contact or non-product-contact. Define Cleaning Scope Clearly specify which...
Quality Inspection in Pharmaceuticals

Quality Inspection in Pharmaceuticals

Quality Inspection in Pharmaceuticals Quality inspection in pharmaceuticals is a critical step to ensure that drug products meet regulatory standards, patient safety requirements, and therapeutic efficacy. It involves systematic checks, tests, and verification across...

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