cGMP Systems, Inc. - Everything GMP!

Validation Guidelines

Available Guidelines Features

Computer and Control Systems Filling and Packaging Lines • Rapid protocol creation
PLC/SCADA Systems Filling Lines Instead of creating new test procedures
Distributed Control Systems Solid Dosage Packaging Lines
IS/IT Systems Inspection Systems from scratch, you can create a draft IQ,
Building Management Systems Stopper Processors OQ, or PQ protocol for a new type of
Labeling Equipment equipment in minutes -- then just edit
Equipment – Biotech Capper/Sealer Systems the draft to reflect the details of the
Ultrafiltration/Diafiltration Blister Packaging Lines
Bioreactors equipment model.
Centrifuges Laboratory Systems
HPLC/GC Systems • Available in three forms
Chromatography Systems
Biotech Processes Gel Electrophoresis Systems − Individual IQ, OQ, and PQ protocols
Ion Chromatography Systems as Microsoft Word documents that
Equipment – General Osmometer Systems can be inserted into your own com-
Filter Integrity Tester Fluorometer Systems
Steam Autoclaves
pany templates.
Spectrophotometer Systems
Bin Washers Dissolution Test Systems − Individual protocols plus descriptions
Depyrogenation Ovens of the validation methodology for
Medical Devices
Depyrogenation Tunnels Molding Systems each test.
Lyophilizers Welding Systems − Complete guidelines in database
Incubators/Refrigerators/Freezers
Tanks Utilities form.
Chemical Reactors Purified Water Systems
Water for Injection Systems
• Flexible pricing
Vial Washers
HVAC Systems Prices are based on the number of
Equipment – Solid Dosage Compressed Gas Systems tests in a protocol or guideline. Com-
Granulators Oil-Free Compressed Air Systems plete IQ, OQ, or PQ protocols range
Blenders Clean Steam Systems from $300 to $2,700 (average $800) for
Fluid Bed Dryers Environmental Control Rooms
Tabletting Machines
tests alone. Prices are higher when the
SIP/SOP Systems
Tablet Coaters CIP/COP Systems
validation methodology is included —
Encapsulators Chilled Glycol Systems and for the guidelines in database form.
• Fast pay-back
Most customers recover the guideline
cost in months, as a result of reduced
What is a Guideline? effort to create protocols for new types
of equipment. Request our ROI
spreadsheet to estimate the pay-back
A collection of detailed IQ, OQ, and PQ test procedures period for your context.
and datasheets for validating a specific type of
equipment. A guideline contains from 15 to 40 tests. • Risk-free evaluation
Request our pricelist, then order a
Guidelines also include instructional information, sample protocol. We will refund the
providing users with the recommended corporate purchase price in full within 30 days, if
methodology for each system type. you’re not satisfied with the level of
detail in the tests.

Continued...
 Features (continued)
• Alternative purchasing scenarios
− Obtain draft protocols for a specific
equipment type, when needed, by pur-
chasing individual IQ, OQ, or PQ proto-
cols.
− Fill gaps in your current knowledge base
by purchasing selected guidelines.
− Establish a new baseline standard for
your organization by purchasing the
guidelines for all your installed or
planned equipment types.
• Use with your EDMS or our software
Some customers load our guidelines into
their own EDMS. Others purchase our
VPM knowledge-management software,
which has features and benefits specific to
the validation context:
− Re-use of common tests (including
your own) by multiple guidelines.
− Part 11 compliance.
− Traceability of changes from guidelines
to approved protocols.
Benefits
Lower costs for creating protocols
• The detailed tests in our guidelines reduce
from-scratch test writing
• Validation-team costs can be cut by 10-15%
Faster path to standardization (guidelines are
an industry-tested starting point)
• Without our guidelines, small companies lack
resources to create standards
• And large companies’ standardization efforts
often bog down in committee
Benefits of improved standardization
• Reduced regulatory risk (fines, litigation,
consulting fees to remedy)
• Faster validation reviews (standard format and
consistent level of detail)
• Lower training costs
Contact us today!
Example Guideline
Lyophilizers
DQ Test Procedures
1. Verification of Requirements
2. Verification of Specifications
3. Verification of Traceability
IQ Test Procedures
4. Audit of Weld Documentation
5. Audit of Line Slope Verification
6. Audit of Passivation Documentation
7. Verification of Approved or As-Built P&IDs
8. Verification of Major Component Installation
9. Verification of Support Utilities Installation
10. Verification of Critical Instrument Installation
11. Audit of Sterilizing Grade Filter Integrity Test
OQ Test Procedures
12. Critical Instrument Calibration Test
13. Operational Procedure Compliance Test
14. Local Control Panel Operation Test
15. Safety and Alarm Test
16. Loss of Utility Test
17. Control Loop Test
18. Normal Function and/or Cycle Test
19. Shelf Cooling Rate Test
20. Ultimate Shelf Cooling Test
21. Shelf Heating Rate Test
22. Ultimate Shelf Heating Test
23. Shelf Temperature Uniformity Test
24. Vacuum Control Test
25. Vacuum Leak Rate Test
26. Ultimate Vacuum Test
27. Condenser Capacity and Defrost Test
PQ Test Procedures
28. Verification of PQ Prerequisites
29. Process Simulation Test for Aseptic Processing
30. Product Lyophilization
124 Mt. Auburn Street
Suite 200N
Cambridge, MA 02138-5700
Phone: 617.576.5783
E-mail: info@cgmpsystems.com
www.cgmpsystems.com