Analytical Method Transfer (USP 1224) Guideline
Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use.
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Sterile
Stores Sops
- October 1, 2020
- by admin
Investigation Tools used in Pharma – SOP & Guideline
The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols,.
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GC
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Validation
- September 26, 2020
- by admin
Site Master File (SMF) Preparation SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File.
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Uncategorized
Validation
- September 21, 2020
- by admin
Good Laboratory Practices (GLP) – SOP & Guideline
Standard Operating Procedure SOP for Good Laboratory Practices (GLP) in line with the Schedule L1 requirement of the drug and.
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Validation
- September 19, 2020
- by admin
Investigation of Extraneous Peak in Chromatography
Standard Operating Procedure (SOP) for Handling and Investigation of Extraneous Peak(s) in Chromatography Analysis. What are the Extraneous Peaks: A.
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.
Audit
Checklist
Checklist / Formats
Doc
GC
GLP
HPLC
- January 28, 2020
- by admin
Checklist for Review of Analytical Raw Data (Chemical)
Checklist for review of analytical raw data generated during the chemical analysis of finished drug product, the raw material (API-Active.
GC
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Quality Control
SOPs
- January 9, 2020
- by admin
SOP for GC Column Receipt, Performance Check and Storage
Standard Operating Procedure (SOP) for GC Columns, Receipt, performance check, usage, and maintenance of Gas Chromatography Column. SOP for GC.
