Slp Process & Cleaning Validation Eng

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SNC Lavalin Cleaning Validation Marketing Brochure

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Slp Process & Cleaning Validation Eng

  1. 1. PROCESS & CLEANING VALIDATION SolutionS through Partnering
  2. 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. 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. 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

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