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...
SOP on Alarms
1.0 Objective
The objective is to describe the procedure for electronic alarms installed on processing Equipment, laboratory equipment and instruments.
2.0 Scope
The scope covers the Electronic...
What is Calibration, Verification and Validation in pharmaceuticals?
In pharmaceutical industries these three terms are commonly used. Sometimes there is a confusion between these terms. Here I would like to explain these...
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...
SOP for Management of Equipment
Objective
To lay down a procedure for Management of Equipment.
Scope
This SOP is applicable for Management of Equipment.
Responsibility
Respective heads of user departments shall be responsible of...
In-Process Checks During Blister Packaging
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...
Hold Time Study …..current approach
Hold Time Study Approach......
It is an expectation of regulatory organizations that companies establish and monitor clean and dirty equipment hold times for manufacturing equipment...
Review, Storage, Retrieve and Disposal of Executed Batch Documents
Objective
To lay down the procedure for Review, Storage, Retrieval and disposal of Executed Batch documents.
Scope
This SOP covers the procedures for Review, Storage, Retrieval and...
Product Recall: Introduction, Classification and Recall Strategy
Product Recall: Introduction, Classification and Recall Strategy
Product recall is a method of removal or correction of marketed product of a industry that does not...
