SNC Lavalin Cleaning Validation Marketing Brochure

1. PROCESS & CLEANING VALIDATION
SolutionS
through
Partnering

2. VALIDATION SERVICES
FOR CLEANING
PROCESSES
Manufacturing and
Validation is part of the manufacturing cleaning lifecycle:
of pharmaceutical, biological and
radiopharmaceutical products,
DEvELoPMENt PHASE
and is essential to both regulatory
agencies and the industry. The  Design (equipment and process design facilities)
principles of Good Manufacturing  Qualification of equipment (DQ, IQ, OQ)
Practices (cGMP) and detailed  Protocol validation writing
directives are systematically applied  Product development (formulation)
to all manufacturing, control and
 Cleaning development
marketing activities.
A team of experienced professionals
will be put together in order to
adapt to and meet all the special
requirements of your particular
manufacturing or cleaning process SCALE-uP PHASE
validation project. With this
 Pilot batch
approach, SLP is able to meet
all your needs and adapt to your
 Process optimization
special requirements.  Batch record writing
 Cleaning verification
CoMMErCIALIZAtIoN
 Manufacturing of product
 Process validation (prospective or concurrent (PQ))
 Cleaning validation

3. The validation of manufacturing and cleaning processes helps to ensure the quality of
products. By validating a manufacturing process, we demonstrate and document that a
process will consistently provide a product that meets predetermined specifications and
quality attributes. The same holds true for the validation of cleaning processes, which
enables all risks of contamination – of a raw material or a product by another one – to be
eliminated and demonstrates that routine cleaning and storage of equipment will not cause
any microbial growth.
Validation services offered by SNC-Lavalin Pharma for:
ProCESS vALIDAtIoN 1. Writing of a validation master plan
2. Prospective, concurrent and
retrospective validation
3. Writing and execution of protocols
4. Revision of documentation
5. Writing of procedures
6. Preparation of documentation
for submission purposes
CLEANING vALIDAtIoN 1. Writing of a validation master plan specific
to the validation of cleaning processes
2. Risk analysis
3. Creation of matrixes
4. Development of analytical methods
5. Recovery study
6. Writing and execution of protocols
7. Revision of documentation
8. Writing of procedures
9. Training sessions to operators or
validation personnel

4. AstraZeneca GlaxoSmithKline
Phoenix International Canadian Blood Services
Pfizer Canada
Shire BioChem Inc. Merck Frosst Canada Inc.
Aventis Pasteur Inc. ID Biomedical
Novocol Pharmaceutical Hemosol Inc.
Novartis
MDS Nordion Novopharm
DSM Biologics
Sabex Inc.
Galderma
Estée Lauder
Novex Pharma Inc.
ratiopharm
Draxis Pharma Patheon
www.snclavalin.com/pharma
Head Office
Telephone :
1-800-505-5651
email : slp@snclavalin.com
NORTH AMERICA EUROPE ASIA
ALLENTOWN MONTRÉAL QUEBEC CITY BRUSSELS MUMBAI
SNC-Lavalin 8000 Decarie Blvd. 5500 des Galeries Blvd. S.A. Coppée-Courtoy N.V. /ICCE SNC-Lavalin
5012 Medical Center Circle 3rd Floor Suite 200 Avenue Louise 251 Engineering & Technology Pvt. Ltd.
Allentown, PA 18106 Montréal, Quebec Quebec City, Quebec Box 16 Mirchandani Business Park
USA Canada H4P 2S4 Canada G2K 2E2 B-1050 Brussels 6th Floor, Sakinaka, Andheri (East)
Belgium Mumbai - 400 072
Telephone: 610-391-1037 Telephone: 514-735-5651 Telephone: 418-621-5500 India
Telephone: (32-2) 643.15.11
Telephone: + 91 22 6720 7000
CALGARY PHILADELPHIA TORONTO LYON SNC-LAVALIN INT’L
Wiebe Forest Engineering SNC-Lavalin 789 Don Mills Road Sogequip S.A./Qualifarm AND PROCUREMENT
3613 - 33rd Street NW 436 Creamery Way, Suite 100 10th Floor C.D.12 Beijing, China
Calgary, Alberta Exton, PA 19341 Toronto, Ontario 69360 Solaize Shanghai, China
Canada T2L 2A7 USA Canada M3C 1T5 France Kuala Lumpur, Malaysia
Jakarta, Indonesia
Telephone: 403-670-7300 Telephone: 610-524-5920 Telephone: 416-422-4056 Telephone: 33 (0) 4 78 02 77 44