Dear All
In case API source, Equipment changed during Manufacturing How many batch, validation Needed? how many batch stability to be charge? which condition? please post regarding this any guidelines
Regards//Sivakumar
09894114092
If an API is changed :
-Qualify all the materials.
-Compare all Quality parameters in Q.C
-Carry out 3 R&D batches for process consistancy and validate process.
-If you have purchased from a DMF source you can purchase 3 large quanitities and then carry out inprocess process controls.
-Carry the stability data of all batches if a new API is used.Carry out accelerated stability studies.
Whenever any change in equipment which impact on product quality, process validation shall be performed. As per guideline 3 consecutive batches shall be taken for the study. However based on impact batches can be recommend for stability.
Mahendra Patle
Manager-QA, Lupin Limited, India
09617770205
During blending validation what is the general criteria in the Pharma industry to establish the minimum working volume for
Blender. Is there any specific guideline on same i.e 30% or 20% minimum working volume of equipment (Blender).
Regards
Mahendra Patle
Manager-QA, Lupin Limited, India
09617770205
[quote=mahendrakumarpatle]Whenever any change in equipment which impact on product quality, process validation shall be performed. As per guideline 3 consecutive batches shall be taken for the study. However based on impact batches can be recommend for stability.
Mahendra Patle
Manager-QA, Lupin Limited, India
09617770205[/quote]
Dear Sir
Please clarify Which guidelines says In case Equipment change 3 Consecutive batches taken for validation study?
Regards// Siva
09894114092
The minimum and maximum working capacity of Blender decided during Performance Qualification. Performance qualification of Blender shall be done using Placebo batch at 3 different load. The analytical outcome for the content uniformity shall be evaluated and working range of blender established.
[quote=sivakumara]Dear Sir
Please clarify Which guidelines says In case Equipment change 3 Consecutive batches taken for validation study?
Regards// Siva
09894114092[/quote]
There is no specific guideline to insist for 3 consecutive batches stability for equipment changes. The number of stability batches inception based on the following conditions
- Equipment change with different design
- Like to like equipment change
- Key component change in the equipment eg; agitator
Based on the nature of the change you can evaluate the change as per your in house change control system and decide the number of batches for stability inception as per change impact analysis.
Regards
Mr.Prasad,
You need to consider 3 batches. Its a statistical approach. Many points are not reflected as guidelines, but we take them from various allied industries For Ex Food, Milk Industry.
Hi,
Major changes like API sourcr, Batch quantities etc…, the process has to validated for three consiquitive batchs.
Hi,
As per the New FDA guidance on Process Validation, It is not sufficient only to validate 3 batches, There should be a framework in which Process design, process Qulification and Process performance are evaluated. Process design once done remains the same as long as there is no change in the process parameters. When the equipment changes, you need to re look the process design, document it and then do the process qualification with the new equipment.