Which is the range for the validated batch size(for example ±5%, 10%) is acceptable?

Eva lee

Registered
#1
:)Hi to Everyone.
We have complete our process validation of our product using the full scale batch size. However , I dont think we could product very just the batches size of what we validated for each batch.
So, Which is the range for the validated batch size(for example ±5%, 10%) is acceptable?
Is there a official document issued by any FDA/MOH in where is defined the range .
Do you also have information on this issue?

Thank you for you support.
 
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optomist1

A Sea of Statistics
Super Moderator
#2
...pls clarify:
"Full Scale Batch Size?
"Range of Validated Batch Size?

Separately, sharing details (where not sensitive) re: the process/product in question will help..
Cheers Optomist1
 

Eva lee

Registered
#3
Product: powder for injection
Size that validated by process validation: 400,000 vials
What we want know: the size range allowed /acceptable for real production of each batch, for example, 400,000 vials ± 10%
 
#4
As far as I know, batch size is determined by whatever you or your customer think is suitable, or by materials, or sometimes by the production pace. Maybe it's because I'm not familiar with medical industry. It seems like that the batch size is pre-set by your company, can you share any specific reason for that if possible?
 
#5
In fact, This question regarding the size range of products of the grouped batch is determined by you and your customer and it has not specified clearly this requirement in the medical quality management system. however, the change of size range would add your manufactured cost and time.
 

Enghabashy

Quite Involved in Discussions
#6
the technical file for each medical product should be considered as reference of company procedures , specially QC , i.e , the following MS ISO 13485, clause :d) procedures for measuring and monitoring;

4.2.3 Medical device file
For each medical device type or medical device family, the organization shall establish and maintain one
or more files either containing or referencing documents generated to demonstrate conformity to the
requirement of this International Standard and compliance with applicable regulatory requirements.
The content of the file(s) shall include, but is not limited to:
a) general description of the medical device, intended use/purpose, and labelling, including any
instructions for use;
b) specifications for product;
c) specifications or procedures for manufacturing, packaging, storage, handling and distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f) as appropriate, procedures for servicing.
 

Enghabashy

Quite Involved in Discussions
#7
The determination of samples size should be outlined as the one of :7.3.6 Design and development verification which stated statistical techniques with rationale for sample size.

-The organization shall document verification plans that include methods, acceptance criteria and, as
appropriate, statistical techniques with rationale for sample size.
 

Semoi

Involved In Discussions
#8
In order to setup an acceptance sampling plan you need to choose four quality quantities:
1. The producer risk alpha,
2. The specified quality of the batch, which you ensure with the above defined producer risk,
3. The consumer risk beta,
4. The specified quality of the batch, which you ensure with the above defined consumer risk.
As an example: If the batch has a quality of 99%, we like have a producer risk <= 5%. However, if the batch has a quality of 91%, we like to have a consumer risk <= 10%. Assuming that we have a binomial distribution we are able to calculate that we need a sample size of 58 and that the allowed failure rate to pass is 2. These tips of calculations can be easily done for different distributions and different choose values. However, nobody can define the acceptable/needed values for you -- you will have to define them yourself.
 
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