Handling of Out of Trend (OOT) Analytical Test Results
Out of trend (OOT), results are those results that are within the specification but indicate that the particular analysis or
Audit
cGMP
Checklist
Checklist / Formats
GLP
QC Sop
SOPs
cGMP
Checklist
QC Sop
Quality Control
SOPs
Stores Sops
SOP for Sampling of Raw Material
Standard Operating Procedure (SOP) for Sampling of Raw Material (API & Excipient) as per Schedule M and ICH Q7 (Good
cGMP
Production
Production Sop
SOPs
Stores Sops
SOP for Dispensing of Raw Material
Standard Operating Procedure for Dispensing of Raw Material (API-Active Pharmaceutical Ingredient and Excipient) to the production department for the manufacturing
cGMP
GLP
QC Sop
SOPs
Validation
SOP for Working/Reference Standard Qualification
Standard Operating Procedure for Qualification, Handling and Usage Of Reference Standards, Calibration Standards, Impurity Standards, Working Standards, and Working Standard
Audit
cGMP
Checklist / Formats
GLP
Quality Control
SOPs
SOP for Electronic Data Management (Laboratory)
Standard Operating Procedure (SOP) for Electronic data backup, restoration, archival, retrieval and scheduled verification of stored data of quality control
Audit
cGMP
Checklist / Formats
GLP
QA Sop
SOPs
SOP For Handling of Laboratory Incident
SOP for handling and reporting of Laboratory Incident (Lab Event ) occurs in the Quality Control like be-Bracketing standard failure,
Audit
Checklist
Checklist / Formats
Quality Control
SOPs
SOP for Review of Analytical Report and Raw Data
Standard Operating Procedure (SOP) for Review of Analytical Report and Raw Data. Analytical raw data is data generated during sample
cGMP
Production
SOPs
Stores Sops
SOP for Issuance of Packing Material
Standard Operating Procedure for Issuance / Dispensing of Packaging Material (Packing Materials) like Corrugated box, Primary Packaging Material (PPM), Secondary
Calibration
Checklist / Formats
GLP
Micro Sop
Microbiology
QC Sop
Quality Control
SOPs
Operation and Calibration of pH Meter
Standard Operating Procedure (SOP) for Operation, standardization, calibration, and maintenance of pH meter including pH meter electrode care. SOP for
Checklist
GLP
Quality Control
SOPs
Stores Sops
SOP for Handling of Laboratory Reagents
Standard Operating Procedure (SOP) for Receipt, Storage, and Handling of Laboratory Reagents, Buffers, Solvents, Glasswares and other consumables in QC.
