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Blood Banking (CFR 21 PART 606) Change Control Requirements

H

HPLC_Help

#1
Hi -

I can't find any mention of Change Control in this part.

Does this mean blood banks' SOPs don't require it?

I doubt this is true - I probably missed something - but if anyone can shed some light, I'd appreciate it!

H_H
 
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#2
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Blood bank SOPs do have to be controlled it falls under the requirements of document control of the blood bank's QMS.

I'm not familiar with 606 though, so I can't be more specific.
 
H

HPLC_Help

#3
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Thank you, J0anne.

606 is the cGMP part for blood and blood components.

There is a section that refers to using the SOPs of the American Association of Blood Banks and the American Red Cross, but I'm wondering how to find the specific requirements of those organizations that state documents must be controlled.

I am sure such documents must be controlled (or - in any case SHOULD be controlled) but I can't find the reg. I even did a word search on "control" in the entire Part, but didn't find anything similar to Change Control requirements, such as those in 820 Subpart D and G, for Document Control and Process Control.

Thanks!
H_H
 
Last edited by a moderator:
#4
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Try Subpart I--Records and Reports - Sec. 606.160 Records.

Would this not apply to any processing procedures?
 
I

isoalchemist

#5
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

:2cents:Not a Blood Bank expert, I just found it interesting that document control appears to be missing in area of the CFR.

Take a look at 600.12 that deals with maintenance of records the wording they use could be seen as the document control requirement. The phrase "be as detailed as necessary for a clear understanding of each step..." sound more like SOP control than record control.

Again interested in the topic not an expert!
 
H

HPLC_Help

#6
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

:thanks::thanks:

Both references provided, to my eyes, seem to have more to do with the records generated (notebooks, worksheets, etc) than they do with the procedures to be followed. But I could be wrong.

In Part 211 and 820, the regulations specifically address changes to procedures. But I can't find it addressed in similar fashion for bloodbanking - which seems very strange.

We deal with some blood banks, so I can find out what their interpretation is.

I appreciate the input, and welcome more. It's really just a niggling thing, not a big deal, as we have a change control process that seems to work well.

H_H
 

Marcelo

Inactive Registered Visitor
#7
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

I?m also no expert, but the usual documetn control that in other GMPs are a separate requirement seem to be in the case of 606 in (maintained probably meaning anything other GMPs requires for document control, including change control):

Subpart F--Production and Process Controls

Sec. 606.100 Standard operating procedures

(b) Written standard operating procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the areas where the procedures are performed.
 
H

HPLC_Help

#8
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Thanks, Marcelo, I think that is probably correct!

H_H
 
R

Rashmi001

#9
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Under EU GMP it states that 'documents should be designed, prepared, reviewed...etc' does CFR 21 have a similar statement ?

In which case, this would fit in with a requirement for a document change request- the purpose being that when creating/changing SOPs that full consideration is given to how the written change may affect the 4P's ; People,Product, Process, Premises, and all aspects of the regulations are taken into consideration.

I have never been cited by MHRA on document change requests, though our inspectors have always been very helpful and given suggestions on improving practices by raising a document change request.

You could also try asking this question on the specific Blood bank forum- www.Pathlabtalk.com

Best wishes

Rashmi
 
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