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 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...
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...
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...
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 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...
SOP on Stability Studies for Drug Products
1.0 Objective:
To lay down a procedure for carrying out stability studies of drug products.
2.0 Scope:
This SOP is applicable for carrying out stability studies of...
Sampling, Preservation and Storage 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...
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...
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...
