Sir, We performed one concurrent validation in 2019. Now we want manufacture tow batches for same product under same parameters. Then shall we perform again concurrent validation or go with prospective validation
Objective of performing Concurrent and Prospective validations is different. Prospective validation is performed when a new product, new formula is to be launched for the first time or faciltity is new. While concurrent validation is performed when product is being currently manufactured, there is a good process knowledge and only minor / few changes are to be executed in the revised process.
Therefore, based on these objctives you have to decide what type of PV is to be carried out. Please remember that you can not release the PV batches untill PV is completed and data is reviewed by QA and approved if found satisfactory. While in concurrent PV individual PV batches can be released for sale if those meet finished product specification and manufacturing process is found satisfactory.
Thank you for your answer sir,
If existing validated process has a minor change shall we perform validation compulsory with 3 batches?
Yes. At least 3 consecutive batches should be considered for concurrent PV.
Hi sir can you please teach me about whole process validation and it’s type their type and of difference
Please send your personal e-mail id.
Ok thank you sir
Hi, am not sure if this is allowed but i saw you conversation with the other guy and i am also interested in process validation. I had a question earlier but no one responded yet. When it comes to sampling, how do decide number of samples for Bulk and for packed samples?
If this is not a bother, may you please just give some info on implementing Continuous process verification, stage 3 of PV.
Hello Juju & Nitesh,
Thanks for your interest shown in learning Process Validation aspects. Yes, surely I will try to explain you about Process validation, Sampling during process validation and other important aspects of it shortly.
Thank you so much sir😊
Hi sir any online courses are available for learning more about pharma knowledge?
Can anyone pls help me? Is PQ is same as process validation?
I have new equipment in our facility. I will do the performance qualification for the same equipment. I am just wondering, do we need to do the process validation for the product?
During PQ, we will do 3 batches, it will be sampled for chemical and microbiological testing, so I am skeptical.
To brief for more clarification, the product we get from the drying room and process with the new equipment and the end product will be packing/bottling right after the step from the equipment.
can respond here or email @ [email protected]
I really appreciate any help you can provide.
Although there are short term courses run by pharmaceutical institutes and colleges, but there you could get theoretical knowledge rather than practical aspects. Therefore, to gain practical experience you will have to work in pharmaceutical company. Theoretical knowledge can be gained through reading books, referring scientific & technical websites.
Hi Sir Please can you provide how to decide or select process validation sampling location and quantity and their procedure at
- Dry mixing stage
- Drying stage
- Blending stage
- Filling / compression stage
- Coating stage