Standard batch size

Quality Assurance
1

What does standard batch size depend upon in pharma industry ?
Plz give suggest

1 Like
2

It depends upon the manufacturing equipment’s capacity and in some cases it depends upon the finished product dosage…

3

Sir if machine capacity 80000 vials /hours
So in case what is standar batch size

And market order is 40000 so can we proceed bmr

4

You can have batches as small as 1 unit (is it is often the case for specific sterile preparations that must be prepared strictly specific for one pacient (USP 797)), or as big as you can possibly can. You can even have continuous manufacturing (no defined batch sizes); FDA has recently (march 2023) issued a guideline for continuous manufacturing (Q13 Continuous Manufacturing of Drug Substances and Drug Products).

So how to define the standard batch size? First of all, the smaller the batch size, the less capacity of production you have, due to all the time it takes to perform all controls needed for start and end of batch (e.g., cleaning, documentation, sterilization, line clearance, line set up, etc.). But also, the larger the batch size, there is a higher risk for quality and for product release (e.g. batch homogeneity), since a failure in a batch will entail much more product if the batch is larger; and some controls can be less reliable for larger batches, like finished product samplings or AQL based acceptance samplings.

In short, what drives the decision to define the standard batch size are:

  • Market demand of product (you want to have the flexibility needed to meet specific demand that could have seasonal variation or other sources of variation)
  • How much can you control your process so that even the largest batches you are able to demonstrate product homogeneity and compliance with all cGMP requirements, consistently.

I hope this helps.

1 Like
5

Thanku so much

6

Sir my question one is
If we have a container of ceftriaxone sodium powder is 10 kg.
And our nedded only 3 kg. From it so after take rm. What is the process of handling of loose container and can we used this loose qty. For next plan.If we can use further so what is sop/guidelines.
And how to maintain sterilty assurance level.

Plz give suggestion