SBS - The best value in QMS software

Blood Banking (CFR 21 PART 606) Change Control Requirements

H

HPLC_Help

#1
#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
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
J0anne

J0anne

Joanne
#2
#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
#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:
J0anne

J0anne

Joanne
#4
#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
#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
#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
 
M

Marcelo

Inactive Registered Visitor
#7
#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
#8
Re: Any Blood Banking (CFR 21 PART 606) Experts Here?

Thanks, Marcelo, I think that is probably correct!

H_H
 
R

Rashmi001

#9
#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
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
B Health Canada - Blood Glucose Meter Registration Canada Medical Device Regulations 0
Aliken Container for the blood bags and medicines EU Medical Device Regulations 2
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
S How to consider the relevant standards during development of ISO13482:2016 for IVD manufacturing Blood grouping Other Medical Device Related Standards 6
R Industrial accidents - Cleanup & disposal of blood spill Occupational Health & Safety Management Standards 1
M Vacuum Blood Collection Tubes EU Medical Device Regulations 1
T To Identify the Applicable MDD Directive - Prepared blood smear EU Medical Device Regulations 13
F Biocompatibility Device Categorization: Priming with Blood Other Medical Device Related Standards 1
M 2016 FDA Final Guidance for Blood Glucose Monitoring Systems - Implementation Other US Medical Device Regulations 2
J Blood glucose monitoring device testing - GLP or GCP Other US Medical Device Regulations 1
A FDA Blood Pressure Monitoring Equipment Measurement Requirements US Food and Drug Administration (FDA) 1
B What is the safe Temperature Limit for Medical Device with blood contact ? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A German MTK (MPBetreibV ? 11) Blood Pressure Meter Requirements EU Medical Device Regulations 2
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
C What would be the Device Classification for a Blood Pressure Monitor in EU ? EU Medical Device Regulations 3
R Applicable Medical Device Standards for Home Use Blood Pressure Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Thermal Sensitivity Testing - Heat Lamp - ILY - Increased blood circulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Blood Collection Inventory Control Procedure example wanted Business Continuity & Resiliency Planning (BCRP) 3
R Classification of Applied Parts - Blood Measurement Sensors IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S FMEA and Control Plan in a Cord Blood Bank FMEA and Control Plans 2
P ISO 15197:2013 (Blood glucose monitoring system) was released in May Other US Medical Device Regulations 10
Ronen E Abbott Voluntary Recall of FreeStyle lnsulinx? Blood Glucose Meters Other Medical Device and Orthopedic Related Topics 0
P Do we need to submit Special 510K for a Blood Glucose System? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
AnaMariaVR2 FDA OKs Bluetooth-enabled blood glucose monitor from LifeScan US Food and Drug Administration (FDA) 5
H Validated Software - IND study to get a BLA (Blood Analysis Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I Blood Glucose Monitor & its Logbook Website - Do I need to get 510k for the Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Phthalate Free Products - Risk Management of a device that holds blood EU Medical Device Regulations 3
R Blood Pressure Transducers - Need to perform EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Blood Bag Classification - with Disposable Centrifugal Unit for processing blood EU Medical Device Regulations 4
D Regulation for importation of Blood Collection Set into India Other Medical Device Regulations World-Wide 1
N Sterilisation of IV Bags used for Veterinary Blood Plasma Products ISO 13485:2016 - Medical Device Quality Management Systems 7
D Windows CE Operating System - Implantable Blood Pump and a Software Accessory Device IEC 62304 - Medical Device Software Life Cycle Processes 8
P Standards related to ER Checklist for Blood Grouping Reagents CE Marking (Conformité Européene) / CB Scheme 2
D Off Label Usage (Class II Medical Device - Blood Bank Software) US Food and Drug Administration (FDA) 3
B IVD Laboratory Blood Processor - Applicable standards? IEC61010-1, -2-101? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Classification (Medical Device or Drug) of Blood Bag in Japan Japan Medical Device Regulations 6
E US FDA Blood Loss Policy - Dislodged Hemodialysis Needle Other US Medical Device Regulations 3
A Regulation for manufacturing & marketing external Blood Test Diagnostic Kit in India Other Medical Device Regulations World-Wide 2
Michael Malis Blood Temperature Monitoring for Transportation General Measurement Device and Calibration Topics 2
W Applying for 510(k) Submission for Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Blood Glucose Monitor - Sample 510(k) submission application 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Michael Malis CLSI Proposed Guideline for Validation and Verification of Tubes for Blood Collection US Food and Drug Administration (FDA) 1
W Classification for Blood Lancet in India, Indonesia, Malaysia and Pakistan Other Medical Device Regulations World-Wide 6
C Establishment Register Question - Subcontracting - Blood Glucose Monitor System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
C Can Blood Glucose Monitor Test Strips be sold individually? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
R IEC 61010 vs IEC 60601-1 to ISO 15197 - Blood glucose monitoring device IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
Icy Mountain Why You Should Donate Blood... Coffee Break and Water Cooler Discussions 16
C Medical Device "accessory" - Blood pressure monitor (BPM) power supply EU Medical Device Regulations 7
V Is spray painting allowed for non-blood contact medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Monitoring the Use of Blood and Blood Products - Meeting the JCI Standards Statistical Analysis Tools, Techniques and SPC 6

Similar threads

Top Bottom