Process Validation

GOOD VALIDATION PRACTICE (cGVP)
1

We are looking at manufacturing an S2 OTC product aseptically. Given our production/ commercial batch size is 10000 vials, I have 2 questions:

  1. Do you require 3 validation batches?
  2. Do the batch sizes require to be 10,000 or can they be smaller? ie. 10% of commercial batch size?

Thank you

Austin. D.

2

In my opinion the three validation batches are a requirement. What could be more flexible is the batch size, provided that the validation runs are representative for the production run. This is impossible to decide without going specifically into your process, but, for example, if an aseptic product is sterilized in an autoclave, in two autoclave loads per batch, you could reduce the batch size to one half because the thermal load and loading pattern will not be affected, and run three consecutive batches as validation batches.

Best regards

Alfred

3

Yes, it’s a requirement I agree with alfred.
What we do is we validate batch size we normally produce. If your batch size is 10000 then do a process validation intended for that batch and if your company all so do small batches then do same thing…

4

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5

[quote=ronakmodi143]I Have Some Questions?
Can Anyone Tell Me How To Make A Post Or How To Post And Ask A Question[/quote]

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6

[quote=Austin]We are looking at manufacturing an S2 OTC product aseptically. Given our production/ commercial batch size is 10000 vials, I have 2 questions:

  1. Do you require 3 validation batches?
  2. Do the batch sizes require to be 10,000 or can they be smaller? ie. 10% of commercial batch size?

Thank you

Austin. D.[/quote]

Process validation must be perform on actual batch size, and perform on three consecutives batches.
Regards

7

[quote=Austin]We are looking at manufacturing an S2 OTC product aseptically. Given our production/ commercial batch size is 10000 vials, I have 2 questions:

  1. Do you require 3 validation batches?
  2. Do the batch sizes require to be 10,000 or can they be smaller? ie. 10% of commercial batch size?

Thank you

Austin. D.[/quote]

Please be clear that 10% of the commercial batch size is usually a pilot scale batch. A Validation batch size is always same as that of commercial one however one can not market these batches till results in validation report are obtained satisfactory.

8

The process must be validated for the smallest and the largest batch sizes. There may be no need to carry out process validation for intermediate batch sizes if it could be demonstrated, based on risk assessment, that process consistency can be achieved for any intermediate batch size.

Regards,

9

[quote=Shahnawaz]The process must be validated for the smallest and the largest batch sizes. There may be no need to carry out process validation for intermediate batch sizes if it could be demonstrated, based on risk assessment, that process consistency can be achieved for any intermediate batch size.

Regards,[/quote]

This could be a new point! can you please elaborate “process must be validated for the smallest and the largest batch sizes” and "intermediate batch sizes " with a reference?

10

It is preferred that the batches made should be the same size as the intended batch size for full scale production for process validation But there is one more approach which is called matrixing approach This may not always be practical that batch sizes made same sizes as the commercial batch size, due to a shortage of available starting materials and in such cases the effect of the reduced batch size should be considered in the design of the protocol. When full scale production starts, the validity of any assumptions made should be demonstrated. This is an example of minimum batch size.
In some cases the batch size can be changed up to 10% with the on-going study by using the same equipment this is an example of maximum batch size. Matrixing by batch size is permitted if using the same equipment.

[process must be validated for the smallest and the largest batch sizes] reference The 2002 Australian Code of GMP refers to the Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002 http://www.tga.gov.au/docs/html/gmpcodau.htm. Annex 15

Regards,

11

  1. Yes, according to ASEAN aguidelines, you have to complete 3 consecutive production batches using the actual commercial batch sizes.

  2. 10% batch size is only intended for pilot batchsize which fall under option 2 submission for Process Validation Submission.

  3. Furthermore, it is also important that you have completed other critical process PV and PQ eg:
    i. Autoclave & Oven PQ,
    ii. Filter Validation.
    iii. 3 Successful Filling Simulation (Media Fill).
    iv. Cleaning Validation

You can google the net and search for 'ASEAN Guidelines for Process Validation’for more information…

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