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Equipment Qualification

Download more than 500 documents: SOPs, examples, templates, checklists, FDA waning letters, 483 inspectional observations, FDA and other official guidelines, presentations/publications from FDA personnel.

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Standard Operating Procedures

 

SOP
Auditing a Suppliers Equipment Master Validation Plan

S-231-01

 

SOP
Supplier Assessment According to ASTM E2500

S-236

 

SOP
Handling Deviations during Equipment and Computer System Testing

S-238

 

SOP
Change Control of Equipment

S-242

 

SOP
Requalification of Equipment

S-244

 

SOP
Developing an effective Supplier Program to Assist Regulated Users

S-251-01

 

SOP
Selecting the Right Software and Equipment Supplier for Compliance

S-251-02

 

 

SOP
Change Control of Analytical Equipment

S-509

 

SOP
Maintenance of Laboratory Equipment

S-541

 

 

 

SOP
Procedures and Deliverables for Qualification of USP <1058> Instrument Categories

S-630

 

SOP
Qualification of Analytical Equipment

S-632

 

 

SOP
Requalification of Analytical Equipment

S-633

 

 

SOP
Developing and Maintenance of Test Scripts for Analytical Systems

S-635

 

SOP
Qualification of Refrigerators

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

 

SOP
SOP: Calibration and Qualification of Stability Chambers
S-652

 

SOP
Installation Qualification Protocol for Manufacturing Equipment

S-915

Templates / gap analyses / checklists / case studies / examples

 

Checklist
Implementing ASTM E2500

E-141

 

Checklist
What Regulated Users should expect from Suppliers of Equipment and Computer Systems

E-148-06

 

Checklist
What Equipment and Computer System Suppliers should offer to Regulated Users

E-148-07

 

Example
Supplier Quality Agreement 

E-149-01

 

Example
Checklist: Validation and Qualification According to the EU-GMP Annex 15-2014 

E-151-04

 

Example
User Requirement Specifications - 20 Good/Bad Examples

E-308

Examples are equipment and computer systems

 

Example
Suggestions for USP Analytical Instrument Categories.

E-315

 

Example
30 Test Procedures for Laboratory Equipment:
For Operational Performance and Compliance

E-363

This is a must for installation qualification (IQ

 

Example
Validation Plan HPLC System

E-711-01


Example
Requirement Specifications - HPLC System

E-711-02

 

Example
Risk Assessment - HPLC System

E-711-03

 

Example
Design Qualification - HPLC System

E-711-05

 

Example
Performance Qualification - HPLC System

E-711-09

 

Example
Requirement Specifications SFC System
E-716-02

 

Example
Qualification Plan - Stability Chambers

E-721-01

 

Example
Performance Qualification - Stability Chambers

E-721-09

 

Form
Equipment Identification and Location

K-1212

 

Form
Project Schedule - ASTM E2500

K-1251

 

Form
Identification of Subject Matter Experts

K-1252

 

Form
Justification and Documentation of System Risk for ASTM E2500

K-1255

 

Form
Documenting Vendor Assessment for ASTM E2500

K-1256

 

Form
Verification of Proper Installation for ASTM E2500

K-1257

 

Form
Verification Plan for ASTM E2500

K-1258

 

Form
Documenting testing of a balance (K-3303)

K-3303

 

Form

Reporting Test Deviations

K-3304

 

Form
Equipment Records

K-3520

 

Form
Equipment List

K-3521

 

Reference papers and presentations, private authors

Journal publication
Reference Paper: Support from Instrument Vendors for Compliance

A-109

 

Journal publication
Equipment Qualification in Practice

A-234

published in LC/GC Magazine

 

Journal publication
Selecting Parameters and Limits for Equipment Operational Qualification

A-239

published in Accreditation and Quality Assurance

 

Journal publication
Reference Paper: Qualification of Equipment and Computerized Systems

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.

 

Reference Paper
 (Laboratory) Equipment Qualification and Computer System Validation

A-552

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

 

Reference Paper
Qualification of High-Performance Liquid Chromatography Systems, Published in BioPharm

A-553

 

Presentation
Equipment Qualification
The expectations and observations of a European inspector

P-223

Presented at the IVT Equipment Qualification Conference, Amsterdam, December 2006

 

Presentation
USP Presentation on Analytical Instrument Qualification

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.

FDA regulations and official FDA Guidelines

 

Other regulations, official guidelines and recommendations from industry task forces

 

Industry guidance
Guidance on equipment qualification of analytical instruments

H-356

The guidance has been developed by the Laboratory of the Governmental Chemist (LGC) and the UK EURACHEM.

 

Industry guidance
Guidance on equipment qualification of analytical instruments: Liquid Chromatography.

H-357

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)

FDA Presentation
Current Issues: Laboratory Method Validation and Instrument Qualification

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.

 

FDA Presentation
Validation of Computerized Liquid Chromatographic Systems,

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.