Tuesday, July 14, 2020

Changes to USP 38 General Chapter 791 pH

Changes to USP 38 <791> pH in USP 39 1S 1.0 The word “Standardization”has been replaced with the word “Calibration” 2.0 The word“read” has been changed with the word “Record” 3.0...

Significant Change in Pharmaceutical Stability Testing

Significant change for a drug substance is defined as failure to meet its specification during stability testing. Stability of a pharmaceutical product may be defined as the capability...

SOP on Handling of Out of Trend (OOT)

Objective:To lay down a procedure for handling of Out of trend for stability sample Scope:This procedure shall be applicable for handling of out of trend...

Sampling, Preservation and Storage Procedure of Water Sample  

1.0 Objective To lay down a procedure for the Sampling, Preservation and Storage of water sample. 2.0 Scope This Standard Operating Procedure is applicable for Sampling, Preservation...

Preparation and Bio-Burden Monitoring of 70% IPA

1.0 Objective To lay down a procedure for the preparation and bio-burden monitoring of 70% IPA. 2.0 Scope This Standard Operating Procedure is applicable for preparation and...

SOP for Behavior in Quality Control Department

1.0 Objective To lay down a procedure for behavior in quality control department. 2.0 Scope This SOP is applicable to all persons working in Quality Control department. 3.0...

Calibration and Handling of Glassware (Class A and Class B)  

1.0 Objective To lay down a procedure for the Calibration and Handling of Glassware (Class A and Class B) 2.0 Scope This Standard Operating Procedure is applicable...

SOP on Validation of Microsoft Excel Calculations Worksheets

1.0 Objective To lay down a procedure for validation of Microsoft Excel worksheets to be used for analytical calculations. 2.0 Scope This SOP is applicable for validation...

List of ICH Quality Guidelines in Pharmaceuticals  

Revised ICH (International Conference on Hormonisation) Quality Guidelines in pharmaceuticals are given below:    Q1A (R2) - Stability Testing of New Drug Substances and Products Q1...

SOP on Sampling Procedure for Purified Water

1.0 Objective To lay down a procedure for for sampling of purified water samples for chemical analysis. 2.0 Scope This Standard Operating Procedure is applicable for for...