smbdesigngroup.com
Pharmaceutical - Medical Devices - Biotech
http://www.smbdesigngroup.com/projects.html
Blister Packaging Systems. [more info]. Multiple Rotary Labelers c/w Integrated Printing and Vision Inspection. Multiple Inline Labelers c/w Integrated Printing and Vision Inspection… [more info]. Multiple Large integrated Tablet filling and Packaging Lines. [more info]. Large Liquid Filling and Packaging Line. [more info]. Multiple Tablet Presses and Control Systems. [more info]. Tablet Press Preventive Maintenance Procedure Audit. [more info]. Develop and Provide cGMP Training. News, Events, Validation...
smbdesigngroup.com
Validation and Compliance Services
http://www.smbdesigngroup.com/applications.html
Our competitive edge lies with the knowledge and experience of our validation personnel. This provides us with insight in the current validation needs and an intimate understanding of cGMP’s along with a keen awareness of equipment design and practical production requirements. Purified Water (USP, DI, WFI, etc.). Clean Dry Air (CDA). Nitrogen and other gas systems. Waste Water Treatment Systems. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation.
cgmpdesign.com
Equipment Commissioning, Qualification and Compliance services
http://www.cgmpdesign.com/experience.html
Has a extensive expertise in:. The Pharmaceutical, Medical Devices and Biotech Industries. Equipment Design and Construction. Qualification documentation and implementation. Developing Standard Operating Procedures. Development of User Requirement Specifications (URS). Detailed Design Specifications (DDS). Pharmaceutical production and packaging. Pharmaceutical production environment and physical facilities. Operator and Maintenance personnel training. Does Therein lies the competitive edge; SMB.
cgmpdesign.com
Pharmaceutical Equipment Validation Services
http://www.cgmpdesign.com/services.html
We use an efficient systematic approach to protocol development which allows for the preparation of the documentation in the shortest time possible. We also employ a pragmatic, common sense, approach to protocol execution which allows us to fulfill all regulatory requirements efficiently with a minimum of delay and with a minimum of interference with operations. Auditing Services. [more info]. Quality Plans. [more info]. Validation Master Plans. [more info]. Summary Reports. [more info].
cgmpdesign.com
Validation and Compliance Services
http://www.cgmpdesign.com/applications.html
Our competitive edge lies with the knowledge and experience of our validation personnel. This provides us with insight in the current validation needs and an intimate understanding of cGMP’s along with a keen awareness of equipment design and practical production requirements. Purified Water (USP, DI, WFI, etc.). Clean Dry Air (CDA). Nitrogen and other gas systems. Waste Water Treatment Systems. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation.
cgmpdesign.com
FDA Press Releases and Recalls
http://www.cgmpdesign.com/FDAfeeds.html
For the latest FDA Press Releases and Recalls, please check out the headlines below. To read the full article, simply click on the underlined text (link).
cgmpdesign.com
Pharmaceutical, Biotech, Medical device Qualification services
http://www.cgmpdesign.com/markets.html
Serves two distinct customer types in three major markets: The Pharmaceutical, Medical Device and Biotechnology manufacturers or PMDB industry and the Equipment Designers and Builders that are suppliers to the PMDB industry. Additionally, training opportunities exist for those individuals who wish to enter or stay current within the PMDB industry. The primary target market encompasses all PMDB Manufacturers and their immediate subsidiaries that are subjected to FDA. The services of SMB. Training for the ...
cgmpdesign.com
Practical Compliance Information
http://www.cgmpdesign.com/eliterature.html
An efficient, systematic risk based, quality system approach to documentation enables us to prepare protocols in the shortest time possible. We employ a pragmatic approach to protocol execution allowing us to fulfill all regulatory documentation requirements quickly and efficiently. Vials and Ampoule Packaging. Looking at the customer's needs from all viewpoints: Engineering, Production, Quality, Validation, and Documentation to fully understand the expectations. Labelers, Marking and Inspection Systems.
cgmpdesign.com
Compliance, Validation Questions and Answers
http://www.cgmpdesign.com/faq.html
Ask us a question about equipment validation and we will endeavor to find you the answer or at least point you in the right direction for one. We appreciate any comments and tips on how to make The FAQ page a better information source. Please contact us by e-mail at Questions@SMBvalidation.com. If you find any faults, inaccurate, or otherwise unacceptable information. Who is responsible for Validation? What is an IQ? What does an IQ contain? What is an OQ? What does an OQ contain? What is a PQ? Does Part...
cgmpdesign.com
SMB Validation and Compliance Group
http://www.cgmpdesign.com/index.html
Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.