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"Special Process" Validation Requirements (21 CFR Part 820)

T

TNHunter

#1
Is there any reference anywhere in Part 820 that requires "special processes" to be validated? I cannot find it. I cannot find a definition in the QSR or the FDA website for "special processes".

ISO 13485:2003 does not state anything about special processes either. Where does this come from?

Frustration abounds.
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Hi,

what do you mean by "special"?

I could imagine that you maybe mean processes usually associated with a "special" risk? If yes, sterilization processes would fall under this category, and ISO 13485:2003 does include sections which are dedicated to sterile product and production only.

Moreover, validation requirements for steam, irradiation and ethylene oxide are layed down in dedicated ISO standards which are also recognized consensus standards for the Agency.

Another process FDA regards as special is the reprocessing of re-usable tools. There is a dedicated FDA draft guidance called "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", which apart from sterilization includes cleaning processes.

You may unearth more information from the Agency's website by using this or a similar query in Google: validation process site:fda.gov

HTH,

Gerhard
 
T

TNHunter

#3
Once again my question is:

Where in CFR Part 820 does it state that "special Processes" must be validated?

I know about the requirements for sterilization and validation is performed for those processes in accordance with the standards.

Who defines what is a "special process" when it is not even defined in CFR part 820?
 

Jim Wynne

Staff member
Admin
#4
Once again my question is:

Where in CFR Part 820 does it state that "special Processes" must be validated?

I know about the requirements for sterilization and validation is performed for those processes in accordance with the standards.

Who defines what is a "special process" when it is not even defined in CFR part 820?
I'm no expert in this area, but if the phrase isn't used in the regulations and isn't used in the standards, what is the context? A "special process" by any other name is still a special process and still must be validated. Sterilization seems to fit that description in this context.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Once again my question is:

Where in CFR Part 820 does it state that "special Processes" must be validated?

I know about the requirements for sterilization and validation is performed for those processes in accordance with the standards.

Who defines what is a "special process" when it is not even defined in CFR part 820?
A few links:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1 go to 820.75.

Sec. 820.75 Process validation.
(a) 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. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.

(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).

(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.

(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

http://fda.yorkcast.com/webcast/Play/dd2d4823b14a4e4ca6d60eae43c5ac9c go to presentation around 1h 08 minutes (or slide 61 through 64).
 
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T

TNHunter

#6
I have a customer who states the following:

"The FDA expects special processes to be validated. It is in the QSR's".

I fully accept that processes such as sterilization, injection molding, etc., require validation.

But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?
 

John Broomfield

Staff member
Super Moderator
#7
I have a customer who states the following:

"The FDA expects special processes to be validated. It is in the QSR's".

I fully accept that processes such as sterilization, injection molding, etc., require validation.

But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?
TNHunter,

This extract from the regulation defines the characteristics of a special process:

"Where the results of a process cannot be fully verified by subsequent inspection and test".

This tells me that baking a cake is a special process as subsequent inspection and test would destroy the cake. Consequently we expect the baking process to be validated before the cakes are made and sold.

I hope this example helps you to determine your special processes for yourself.

Best wishes,

John
 

Ajit Basrur

Staff member
Admin
#8
I have a customer who states the following:

"The FDA expects special processes to be validated. It is in the QSR's".

I fully accept that processes such as sterilization, injection molding, etc., require validation.

But can anyone show where in the QSR's it states that "special processes" must be validated? Who defines what is special?
Refer - http://www.fda.gov/medicaldevices/d...ments/qualitysystemsregulations/ucm230127.htm


iii. Process Validation (Sec. 820.75)

143. A few comments on proposed Sec. 820.75 Special processes stated that the meaning of the term ``special processes'' was unclear. Other comments stated that FDA should provide examples of processes that would be considered ``special processes.'' Several comments stated the term ``fully verified'' was unclear and should be deleted. In response to the comments, the term ``special processes'' has been dropped from the regulation and the term ``process validation'' is defined in Sec. 820.3(z)(1). The section now requires that when a process ``cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance. * * *''

Examples of such processes include sterilization, aseptic processing, injection molding, and welding, among others. The validation method must ensure that predetermined specifications are consistently met. The new Sec. 820.75, entitled ``Process validation,'' is consistent with ISO 9001:1994, section 4.9, including the terminology ``fully verified.'' FDA does not believe this terminology is unclear since it has been used in ISO 9001:1987 and 1994 and explained in several guidance documents.
 
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