SOP on Internal Audit and Self Inspection
1.0 Objective
To lay down a procedure for periodic internal audit and self-inspection to ensure current Good Manufacturing practices compliance.
2.0 Scope
This Standard Operating Procedure is...
SOP on Date and Time Format in Written Procedures
1.0 Objective
To lay down a procedure for entering the date and time in all written procedures
2.0 Scope
This Standard Operating Procedure is applicable to...
SOP on In-Process and Finished Goods Testing
1.0 Objective
To lay down a procedure for In-Process and Finished Goods Testing.
2.0 Scope
This standard operating procedure is applicable at pharmaceutical formulation plant..
3.0 Responsibility...
List of QA (Quality Assurance) SOPs
Sr. No.
TITLE
1
Preparation, approval, distribution, revision, control and retrieval of SOP
2
Preparation of Master Formula Record (MFR), Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR)
3
Issuance...
Operating Guidelines in Pharma -A Brief Introduction
1.0 Definition
‘Operating Guideline' (OG) :- A set of instructions directing how to execute an activity. The Operating Guidelines shall be prepared for the execution of an...
Qualification Procedure For External Calibrating Agency
1.0 Objective
To lay down a procedure for qualification of external calibrating agency.
2.0 Scope
This Standard Operating Procedure is applicable for qualification of external calibrating agency,...
Handling of Incidents
1.0 Objective
To lay down a procedure for handling of incidents.
2.0 Scope
This Standard Operating Procedure is applicable for pharmaceutical formulation plant.
3.0 Responsibility
3.1 Executive / Supervisor...
Blinding and Re-labeling of Clinical Trial Samples for Clinical Trial purpose
1. 0 Objective
To lay down procedure for blinding and re-labeling of Clinical Trial samples for blinded Clinical Studies of the drug products.
2.0 Scope
This...
Issuance and Control of Formats /Records / Log Books
1.0 Objective
To lay down a procedure for issuance and control of Records/ Formats / Log Books.
2.0 Scope
This standard operating procedure is applicable for pharmaceutical...
Handling of Out-of-Specification and Out-of Trend Test Results
1.0 Objective
To lay down a procedure for handling of Out-of-Specification and Out-of-Trend Test Results.
2.0 Scope
This SOP shall be applicable for chemistry based testing of...
