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 withdrawal, storage, observation & destruction of control/retention sample
1.0 Objective
To lay down the procedure to withdrawal, storage, observation & destruction of control sample from production (Oral & Injectable), Q.C. (R.M. Retention).
2.0 Scope
This...
SOP on Acceptable Quality Level (AQL) During Product Inspection for physical defects
” Product Inspection for Physical defects ” shall be filed in the Batch Production Record of the respective drug product
In case the incidence...
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...
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...
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...
SOP on Vendor Development, Qualification, De-qualification and Requalification for Raw Materials & Packing Material
1.0 Objective
To lay down a procedure for the approval of vendors for raw & packing material and De-qualification and Requalification of existing approved vendors.
2.0...
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...
SOP on Password Policy For Computers and Softwares in Pharmaceutical Plant
1.0 PURPOSE:
The purpose of the document is to establish a procedure for allocation, maintenance of uniqueness; and confidentiality of passwords which in turn useful...
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...