Thursday, March 28, 2024

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...