When to Validate a Process - 21 CFR Part 820.75.(a)

[eva_deng]

Dear all

In 820.75.(a),
quote
Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.
end quote

I just cann't difference what kind of subsequent inspection and test can verify a process?

any input will be appreciated
thanks in advance
Eva

 

[esalsan]

The Global Harmonization Task Force (GHTF), Study Group 3, published a "Process Validation Guidance" that may be useful for you. GHTF documents are freely available from their website (Sorry, I'm not a regular poster and cannot add hyperlinks yet but should be easy to find in any search engine).

 

[GStough]

Dear all

In 820.75.(a),
quote
Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.
end quote

I just cann't difference what kind of subsequent inspection and test can verify a process?

any input will be appreciated
thanks in advance
Eva

Eva,

The requirement is "where the RESULTS of a process....", not the process itself, "...cannot be fully verified by subsequent inspection and testing...". For example, the results of a process may be a finished product. If the finished product cannot be inspected or tested for whatever reason, then the process by which the product was manufactured must be validated.

I hope this helps.

 

[harry]

The Global Harmonization Task Force (GHTF), Study Group 3, published a "Process Validation Guidance" that may be useful for you. GHTF documents are freely available from their website (Sorry, I'm not a regular poster and cannot add hyperlinks yet but should be easy to find in any search engine).

Check our post attachments list: GHTF process validation guidance

 

[bio_subbu]

Hi Eva

As Gidget Stough said, the requirement for process validation where every specification of every component cannot be verified (e.g., inspected). Refer below few examples.

1. Clinical or destructive testing is necessary to show the process produced the desired result or product. (e.g., In vitro diagnostic test)

2. Routine end-product testing does not examine all quality attributes of the finished device. (e.g., Coating process)

3. When end-product testing does not have sufficient sensitivity to verify the desired safety and efficacy of the finished product. (e.g.,Visual inspection of a weld to seal x-ray tube).

 

[harry]

This post by Roland in this thread is also informative.

Validation of processes is basically done for one of three reasons:

1) You can't test/inspect for it, so you have to validate. Sterilisation is the obvious example here.

2) You can test/inspect for it, but it is more economical to have a validated process instead. Automated camera inspection systems are a good example.

3) The process doesn't need validation (presumably because of subsequent inspection), but the company opts to validate every process anyway, as a belt 'n' braces approach.

 

[tbsiva]

For example, processes like welding....It is impossible to fully verify the product quality by subsequent test/inpsection as it is a destructive test..In these cases, u need to have the highest level of process qualification because if sumthing goes wrong, there is a huge risk....Both internal and external

Process qualification procedure needs to be documented and qualification has to be carried out to the highest degree of assurance

 

[Ajit Basrur]

Great responses so far. Just to add on - there is a good interpretation here - https://medicaldeviceschool.com/820_75 Process validation.html

 

[eva_deng]

This post by Roland in this thread is also informative.

thanks ，Harry
Yes，our products are sterile.
Now,i see.
Thank you all again.