Infrastructure Qualification Procedure – Quality IT
Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer.
Audit
Calibration
cGMP
GLP
QA Sop
QC Sop
Quality Control
SOPs
Validation
Audit
cGMP
Checklist
Checklist / Formats
GC
GLP
HPLC
Protocol
QA Sop
QC Sop
Quality Control
SOPs
Validation
- January 23, 2021
- by admin
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.
Audit
Calibration
cGMP
Doc
GLP
Micro Sop
QA Sop
QC Sop
Quality Control
SOPs
- October 24, 2020
- by admin
Quality Assurance in Laboratory (Lab QA) – Guideline
Standard Operating Procedure (SOP) & Guideline to define the role and responsibility of Quality Assurance in Laboratory (as Lab QA).
Audit
Calibration
cGMP
GLP
QA Sop
QC Sop
Quality Control
SOPs
- October 16, 2020
- by admin
Particle Size Analyzer (Malvern) Operation Calibration
Standard Operating Procedure (SOP) for Operation, Calibration, and Maintenance of Malvern Make Particle Size Analyzer (Mastersizer 2000 & 3000). SOP.
Audit
Checklist / Formats
QA Sop
QC Sop
SOPs
Sterile
- October 2, 2020
- by admin
Contract Laboratory Agreement and Testing SOP
Standard Operating Procedure (SOP) for Contract Laboratory Agreement and analytical testing. It covers all the processes of sample sending, sample.
Audit
Calibration
cGMP
Checklist
Checklist / Formats
Doc
GC
Health & Safety (EHS)
HPLC
Maintenance Sops
Micro Sop
Microbiology
Production
Production Sop
Protocol
QA Sop
QC Sop
SOPs
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,.
Audit
cGMP
Checklist
Doc
Environment
GC
Health & Safety (EHS)
Maintenance Sops
QA Sop
QC Sop
SOPs
Sterile
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.
Audit
cGMP
Checklist / Formats
Doc
Health & Safety (EHS)
QA Sop
SOPs
- September 25, 2020
- by admin
SOP for Training of Contractual Worker
Standard Operating Procedure (SOP) for Training of Contractual Workers in pharma, A contract worker does not become a regular addition.
Audit
Calibration
cGMP
Checklist
Checklist / Formats
Doc
Environment
GC
GLP
Health & Safety (EHS)
HPLC
Maintenance Sops
Micro Sop
Microbiology
Production
Production Sop
Protocol
QA Sop
QC Sop
Quality Control
Research
SOPs
Sterile
Stores Sops
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.
Audit
Calibration
cGMP
Checklist
Checklist / Formats
GC
GLP
HPLC
QA Sop
QC Sop
Quality Control
SOPs
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.
