Tuesday, February 20, 2018

In-Process Checks During Blister Packaging

During Blister packing of solid oral dosage followings are the In-process checkpoints: After running the machine in initial, a piece of blister foil to...

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...

SOP On Facility Designing and Qualification

1.0 Objective To define the Standard Operating Procedure for Facility Designing and Qualification. 2.0 Scope 2.1 This SOP is applicable for pharmaceutical Facilities. 2.1.1 When designing new facility. 2.1.2...

Quality Assurance (QA) Management Procedures

In this episode you will find Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of...

Assigning Manufacturing and Expiry Date

Objective: To lay down a procedure for assigning manufacturing and expiry date to the finished products being manufactured. Scope: This SOP is applicable for assigning manufacturing and...

URS (User Requirement Specification) Sterile API Facility

 USER REQUIREMENT SPECIFICATION                    STERILE API FACILITY 1.0 Introduction  1.1 Scope of the Project:                                                           The project envisages setting up of a Greenfield Sterile API manufacturing facility and...

SOP for Code to Code Transfer of Materials and Additional Testing of Materials /...

Objective To lay down a procedure for code transfer of same material from one code to another and to carry out additional testing of APIs,...

In-Process Checks (Stage – Dry Syrup Packing)

In case of In-process during stage of packing weight check is very important, following are the procedure for the same: Collect one bottle...

Testing of Primary Packaging Materials

1.0 Objective To lay down a procedure for Testing of Primary Packaging Materials. 2.0 Scope This Standard Operating Procedure is applicable pharmaceutical formulation plant. 3.0 Responsibility QC- officer...