Equipment
Download more than 350 documents: SOPs, examples, templates, checklists,
FDA waning letters, 483 inspectional observations, FDA and other official
guidelines, presentations/publications from FDA personnel.
S-240
S-628
S-241
S-242
S-915
S-509
S-644
Includes qualification of refrigerators throughout the entire cycle:
Comparing user specification with vendor specification, vendor
qualification, installation, initial and ongoing testing. For refrigerators
used to keep samples, chemicals, reference standards and reagents below
specified temperatures.
E-308
Examples are equipment and computer systems
E-312
Such lists should be prepared at the beginning of a corrective action
plan to bring a laboratory into compliance. It includes a column on the
actual validation status and validation requirements for each instrument.
E-314
This is a must for installation qualification (IQ) documentation.
E-711-02
E-711-05
E-711-04
E-414
An HPLC lab with 12 HPLCs must be qualified. The case study gives
examples for user requirement, functional and operational specifications. It
also lists parameters and acceptance for operational qualification testing.
K-3303
P-223
Presented at the IVT Equipment Qualification Conference, Amsterdam,
December 2006
P-517
Horacio N. Pappa, Ph.D, from the USP Department of Standards Development
gave an update on the new USP general chapter <1058>: "Analytical Instrument
Qualification" at the London IVT conference: Laboratory Regulations,
Controls and Compliance.
A-264
Using examples from an analytical laboratory , this paper will guide
users of equipment and computerized systems through the entire qualification
process from DQ to IQ, OQ and PQ.
A-553
A-234
published in LC/GC Magazine
A-239
published in Accreditation and Quality Assurance
H-357
The guidance has been developed by the Laboratory of the Governmental
Chemist (LGC) and the UK EURACHEM.
H-356
The guidance has been developed by the Laboratory of the Governmental
Chemist (LGC) and the UK EURACHEM.
Presentations, publications, interviews with FDA personnel (these are
not official guidelines)
G-360
Powerpoint presentation from FDA's Dr. Moheb M. Nasr, Division of
Pharmaceutical Analysis at CDER. Dr. Nasr starts with a statistics on Drug
GMP 483's and Warning Letters: The majority of the cited deviations are
related to Laboratory Systems. Dr. Nasr continues with specific
recommendations for validation of HPLC procedures and the qualification of
systems. He follows the 4Q lifecycle model and gives examples for DQ, IQ,
OQ, and PQ. He also gives FDA's expectations on what should be included in
System System suitability. The presentations ends with examples of FDA 483's
and Warning Letters and with FDA's expectations on how to avoid them.
G-362
William B. Furman and Thomas P. Layloff, Ronald F. Tetzlaff
U.S. Food and Drug Administration
This article has also been published in AOAC journal and promotes the
holistic approach for the validation of computerized analytical system,
where it makes sense. There are some exceptions to this approach.