Out of Specification (OOS)- SOP and Formats
Standard Operating Procedure (OOS) for the handling of Out of Specification Test Results, This SOP is designed based upon MHRA.
Checklist / Formats
GLP
Protocol
QA Sop
QC Sop
Quality Control
SOPs
Calibration
Checklist / Formats
GC
GLP
Protocol
- March 7, 2020
- by admin
Calibration of Gas Chromatography (GC)
Standard Operating Procedure (SOP) for Calibration of Gas Chromatography (GC), parameters are Carrier Gas flow Accuracy, Calibration of Flame Ionization.
cGMP
Checklist / Formats
Protocol
QA Sop
QC Sop
Quality Control
SOPs
- January 25, 2020
- by admin
Stability Study SOP as per ICH Guideline
Stability study sop prepared according to ICH guidelines with required stability study sample incubation, sample pullouts and analysis of samples.
cGMP
Protocol
QA Sop
SOPs
Validation
- December 21, 2019
- by admin
Process Validation SOP and Protocol
Process Validation: Establishing documented evidence through collection and evaluation of data from the process design stage to routine production, which.
cGMP
Checklist / Formats
Protocol
QA Sop
SOPs
Validation
- December 18, 2019
- by admin
Technology Transfer of Drug Product
Technology transfer/product transfer is a complete documented process that covers the detailed documentation for manufacturing and dispatch of the first.
cGMP
GLP
Protocol
QC Sop
Quality Control
SOPs
- December 7, 2019
- by admin
SOP for Reduced Testing
Standard Operating Procedure (SOP) for Reduce Testing in Raw Material (API and excipients), This will help to increase the productivity.
cGMP
Checklist / Formats
Protocol
QA Sop
Validation
- November 27, 2019
- by admin
Hold Time Study of Cleaned Equipment (CEHT)
Introduction : Cleaning is necessary to avoid cross contamination from one product to another. Cleaning process used for cleaning of equipments.
cGMP
Doc
Protocol
Validation
- October 31, 2019
- by admin
Cleaning Validation Protocol -CV
A cleaning validation protocol shall be developed for the ‘worst case’ product selected for the cleaning validation program. Following information.
