Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword
Like this
10Activity
0 of .
Results for:
No results containing your search query
P. 1
AABB Accreditation

AABB Accreditation

Ratings:

3.0

(1)
|Views: 667 |Likes:
Published by gabababa
Satisfying Validation and Calibration Requirements for AABB Accreditation
Satisfying Validation and Calibration Requirements for AABB Accreditation

More info:

Published by: gabababa on Nov 05, 2008
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PPT, PDF, TXT or read online from Scribd
See more
See less

11/08/2012

pdf

text

original

 
Biometrix Corporation 800-890-8909www.biometrix.com 1
Satisfying Validation andCalibration Requirementsfor AABB Accreditation
 
Biometrix Corporation 800-890-8909www.biometrix.com 2
Validation and Calibration for AABBAccreditation
AABB Accreditation now requires full cGMP calibration andvalidation compliance
“Good manufacturing practice (cGMP) regulations, good tissue practice (cGTP)regulations, CLIA ’88 requirements, increased regulations from the FDA for unlicensed blood establishments and transfusion services, the introduction of Quality Management systems, competition within the blood banking profession, advances inthe cellular therapy arena, and increased pressure to improve safety with limited resources have changed the way the blood banking and cellular therapy communitiesconduct business. Conducting business in a quality framework is no longer an option,but a must. Ensuring that all systems are working efficiently and in compliance with AABB Standards and federal regulations is the foundation of any successful operation.” 
 
Biometrix Corporation 800-890-8909www.biometrix.com 3
Validation and Calibration for AABBAccreditation
AABB requires that all accredited facilitiesvalidate their processes:AABB Standard: 5.0 Process ControlThe facility shall identify, design, and
validate
the policies, processes andprocedures that affect the quality of cellular therapy products and services.

Activity (10)

You've already reviewed this. Edit your review.
1 thousand reads
1 hundred reads
Felipe A Nieves liked this
jsharma_20 liked this
luckydinesh liked this
stantonkok liked this
Jim Propas liked this
rabithacr liked this

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->