Blister pack Line validation protocol for Alu/Alu pack
Blister pack Line validation protocol for Alu/Alu pack Objective: To validate the packing process of the product on the Blister Pack line. Scope: Applicable to Blister Packing of tablets....
Category: Validation
Sop for Hold time study
This Document describes (Standard Operating procedure) SOP for hold time study for establishment of hold time of products at various stages such as lubricated granules / blend, compressed tablets, coated tablets and filled capsules,...
SOP for Process Validation
This Document describes (Standard Operating procedure) SOP for Measures Taken during carrying out process validation of drug products. I. Purpose & Scope: The Purpose of this SOP is to lay down the procedure for...
Method validation for filters used in Dissolution
This article contains protocol for method validation for filters used in Dissolution method. Method validation for filters used in Dissolution Method Approval for protocol of Method validation for filters used in Dissolution method ...
What is F0 value in moist heat sterilization process
This article describes the D value, Z value and F0 value which is calculated in moist heat sterilization process What is mean by D value, Z value and F0 Value. What is D value...
Dead Leg in water system
Dead Leg in water system and its Limit as per different Regulatory Guidelines like EU Annex1, WHO TRS 970 and so on Dead Leg in water system What is mean by dead Leg in...
Porous load and non porous load in Autoclave
This article provides information about porous load and non porous load and Mixed Loads. Porous load and non porous load and Mixed Loads What is mean by sterilization ? Sterilization is a process that...
Sop for Analytical method validation
This Document describes (Standard Operating procedure) Sop for Analytical method validation Sop for Analytical method validation. I. Purpose & Scope: The Purpose of this SOP is to lay down the procedure for Analytical method...
Tunnel validation- Indexing the contents Part 1
This article contains indexing of the contents required for depyrogenate and sterilizing Tunnel validation. It contains Depyrogenation and sterilization techniques used in the pharmaceutical industry out of which one technique validating during tunnel validation....
Fh value Calculation in Dry heat sterilization
This article contains the Fh value calculation, Difference between F0 and Fh value, What is mean by Dry heat sterilization and Depyrogenation. What is Mean by Fh value and its Calculation : There are...