ISPE Carolina-South Atlantic Chapter News

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ISPE Releases Active Pharmaceutical Ingredients (Bulk) Guide

(TAMPA, FLORIDA, USA, 20 JUNE 2007) - ISPE, a global not-for-profit Society of pharmaceutical manufacturing professionals representing more than 24,000 Members, has released ISPE Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, Second Edition.

Created in partnership with the US Food and Drug Administration (FDA), ISPE's Baseline® Guides offer practical answers to the complex, dynamic challenges facing facility designers today. In addition to providing an understanding of products and processes, they also offer an outline of architectural and utility systems needed to meet government requirements. Additionally, they address GMP and non-GMP regulations and detail facility commissioning and qualification.

This is the second edition of ISPE’s Baseline® Guide Volume 1, Active Pharmaceutical Ingredients, originally called Bulk Pharmaceutical Chemicals. It was the first of the Baseline® Guide series to be produced (in 1996) and is the first to be revised.

"This revision was prompted by a number of developments and initiatives within the industry, along with comments from users of the original Guide," according to Patrick Wong, of Bristol-Myers Squibb, and Leader of the Document Development Task Team responsible for the Guide.

This revised Guide builds on the original principles, but also incorporates and builds on new regulations and guidance, such as:

  • ICH Q7
  • ICH Q9
  • GAMP 4
  • Later ISPE Baseline® Pharmaceutical Engineering Guide Series
  • 21 CFR Part 11
  • "Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice"
  • FDA Draft Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance

In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the US, and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.

The scope has been expanded and key features of the Guide now include:

  • Active Pharmaceutical Ingredient Characterization
  • Critical Process Step(s)
  • Critical Unit Operation (new)
  • Critical Process Parameter
  • Critical Instruments
  • Contamination Review (new)
  • Design Qualification (new)
  • Intended Patient Use (new)
  • Direct, Indirect, and No Impact Systems (new)
  • Critical and Non-Critical Components (new)
  • Facility Designation (new)
  • Potential Contamination
  • Good Engineering Practice
  • Levels of Protection
  • Process Analytical Technologies (new)
  • Process Review (new)
  • Risk to Patient (new)
  • Understanding of Process (new)

Guide may be purchased for $200 by Members and $400 for non-members by visiting our publications page or by calling ISPE at +1-813-960-2105.

ISPE-PCC Offers New Credential; First Exam Available in July

(TAMPA, FLORIDA, USA, 30 MAY 2007) - Enhanced credibility; peer respect and recognition; greater opportunities for professional advancement; and a competitive edge when job seeking, are some of the benefits that pharmaceutical manufacturing professionals can gain with certification as a Certified Pharmaceutical Industry Professional™ (CPIP™) made available through the ISPE Professional Certification Commission (ISPE-PCC).

This new credentialing program offers the first competency-based international certification for pharmaceutical professionals and covers a range of competencies from drug product development through manufacturing. Candidates are assessed through demonstrated education, experience, and a rigorous examination.

The CPIP program is hailed by many in the industry as beneficial to team leaders, allowing the ability to impact greater quality and efficiency in their specific roles.

"Our industry benefits from employees certified in diverse knowledge, and with the ability to apply this knowledge across all segments of our industry," said Ali Afnan, PhD, of the United States Food and Drug Administration.

According to Donovan Wearne, CEO of SeerPharma Pty Ltd.: "SeerPharma provides expert QA and GxP consulting services to the pharmaceutical, biotechnology, and medical devices industries. In our business our reputation and success absolutely depends on the technical knowledge, innovation and responsiveness to change of our consulting team," said Wearne.

"The CPIP credential is therefore a perfect fit with our corporate vision and aspirations for our consultants and business," Wearne said. "We intend to strategically use the CPIP credential now and in the future to qualify our team and support their ongoing professional development."

The 2007 exams for the new certification for pharmaceutical manufacturing professionals will be available to the industry:

  • 9 July - 4 August
  • 5 November - 8 December

According to Jerry Roth, P.E., Director of Professional Certification, likely candidates for this credential are those who work in drug product development; drug product manufacturing operations; facilities/process engineering; facility and process equipment manufacturing and supply; project management; regulatory compliance/ QA/Validation; and technical support.

Eligibility applications should be submitted at least 60 days prior to exam dates. Those CPIP candidates deemed eligible by the PCC will be authorized to register for and take the exam.

The examination will be available in Thomson Prometric Professional Testing Centers located in major cities around the world. Eligible candidates will be able to make a reservation on-line at a local testing center close to their work or home. To obtain a CPIP eligibility application (free download) or to purchase the CPIP Study Guide, visit www.ispe-pcc.org.

Ferguson Pape Baldwin Architects on Team to Design Carlsbad Desalination Plant

Poseidon Resources has announced the selection of the team that will design and build the proposed 50 million gallon per day, $270 million Carlsbad desalination plant. The plant, the largest desalination facility ever to be constructed in California, will be engineered and constructed by a team that includes American Water, Pridesa America, PBS&J, and J.R. Filanc Construction, with Ferguson Pape Baldwin Architects (FPBA) providing all architectural services.

FPBA has been directly involved with the project for the last several years, developing the architectural designs and supporting Poseidon throughout their public review and entitlement processes.

"The opportunity provided by American Water, Pridesa and PBS&J for FPBA to join their team allows our firm to ensure our initial design concepts will be faithfully implemented. We have been fortunate to team with a group that is fully committed to Poseidon’s and Carlsbad’s vision of this facility as a major element in their long-range plans for the area" said Kennon Baldwin AIA, President of FPBA.

FPBA has designed several major projects in the Carlsbad area including the City Library on Dove Lane, the Cole Library renovation and the near-by Genentech Manufacturing facility in Oceanside.

Appointment Notice:

Veriteq Instruments is very pleased to announce that Mr. Roy Snipes has joined our sales and support team as Regional Sales Manager with responsibility for the Midwest and Southeast regions of the U.S. Roy joins his colleagues, Frank Crisafulli (Northeast and Mid-Atlantic regions) and Keith Loftin (Southwest and West Coast regions), further strengthening Veriteq's U.S. sales and support team.

Roy, who most recently was with GE Kaye Instruments, brings more than 20 years experience in technical sales and support servicing the bio-pharmaceutical, medical device, aerospace and industrial markets.

Roy can be contacted at 919-414-9812 or at rsnipes@veriteq.com.

Additionally, you can of course continue to contact the factory directly at 800-683-8374 for calibration, technical support and service issues. Similarly, you can continue to contact Frank at 774-872-0008 or Keith at 480-657-9911.

At Veriteq, we are committed to providing our customers with the highest level of customer service and support both in the factory and in the field. To learn more about Veriteq’s superior temperature and humidity monitoring and recording solutions, go to our website at www.veriteq.com

Please join me in welcoming Roy Snipes to the Veriteq sales and support team!

Thank you,

Kevin Bull
President & CEO
Veriteq Instruments, Inc

ISPE Carolina-South Atlantic Chapter Remembers Tom Montgomery

Thomas Milburn Montgomery, Chair of the Carolina-South Atlantic Chapter'sMembership Committee andformer member of the Board of Directors, passed away on February 11, 2007 in Raleigh.
Read more...

General contractor McDonald-York promotes company veterans to Vice Presidents

RALEIGH, NC (January 15, 2007)—McDonald-York has promoted Cary Lail, a 10-year company veteran, and Matt Cain, a 7-year company veteran, to vice presidents. In their new roles, they will be responsible for managing client services and overseeing McDonald-York’s construction operations.

"We are delighted to announce that Cary and Matt are now vice presidents of McDonald-York," says John (Jack) McDonald, P.E., President and CEO. "Both demonstrate the analytical skills, attention to detail, and creativity that are critical to the success of the complex projects we build."

Heather E. Denny, Chief Operating Officer, adds, "Cary and Matt, like the majority of our staff, have been with the company for a long time. Our clients can anticipate that they—and the other key personnel they count on—will remain with the company in the long-term and be available to complete subsequent projects or answer any questions about previous work."

Born and raised in Rutherfordton, North Carolina, Lail joined McDonald-York after receiving his Bachelor of Science in construction engineering and management, construction option from North Carolina State University. He holds his North Carolina General Contractor License and his Engineer-in-Training North Carolina certification. In his 10 years with McDonald-York, Lail has managed the construction of numerous commercial, life sciences, and religious facilities, including Raleigh Chinese Christian Church, A.E. Finley Office Building, and GSK Crowe Fowler project.

Born and raised in Asheboro, North Carolina, Cain joined McDonald-York after receiving his Bachelor of Science in construction engineering and management from North Carolina State University. He is a registered North Carolina Engineering Intern and completed the Greater Raleigh Chamber of Commerce Leadership program. In his seven years with McDonald-York, Cain has completed numerous residential and life sciences projects, including Parkview Manor, a 92,000-square-foot senior housing center, and a Gene Expression and Protein Biochemistry Fermentation Lab.

Founded in 1910, McDonald-York is the oldest general contractor in the Triangle. McDonald-York specializes in complex projects that require teamwork and close collaboration. Their market segments include corporate offices, urban infill residential, retail centers, and life sciences. Staff members have an average tenure of 14 years with the company, and the majority of projects completed are for repeat clients.

For additional information, please contact:

Jack McDonald, President and CEO
Tel: (919) 832.3770
jm.mcdonald@mcdonald-york.com

Heather Denny, Vice President and COO
Tel: (919) 832.3770
h.denny@mcdonald-york.com

McDonald-York, Inc.
801 Oberlin Road
Raleigh, NC 27605
www.mcdonald-york.com

CH2M HILL TAPS STEELE AS MANUFACTURING/LIFE SCIENCES VP

Spartanburg, South Carolina, Nov. 8, 2006—CH2M HILL announced today that Sue Steele has been hired as vice president, director of business development, for its manufacturing and life sciences business. Steele has 25 years experience in engineering, construction, and facilities maintenance and operations. Most recently, Steele served as vice president of maintenance technology for a Southeast-based multinational engineering-construction (E&C) firm.

"We are extremely pleased to be able to add Sue to our quickly-growing manufacturing and life sciences group in order to focus on our clients’ value-added needs," said Michael McKelvy, president, manufacturing and life sciences. Steele will be located out of the company’s Spartanburg, South Carolina operations center.

Steele has also previously served as vice president of industrial services for another E&C firm with responsibility for strategic planning, business development and operations results in the engineering-construction industry. She has an MBA from the University of Miami and a B.S. degree from Auburn University. She currently serves on the Construction Industry Institute’s research committee and has previously served on its Board of Advisors and as the 2005 conference chair.

Headquartered in Denver, employee-owned CH2M HILL is a global firm providing engineering, construction, operations, and related technical services to private and public clients. With more than $3 billion in revenue, CH2M HILL is an industry leading program management, construction management-for-fee and design firm, as ranked by Engineering-News Record (2006). The firm’s work is concentrated in the areas of manufacturing, chemicals, electronics, energy, chemicals, pharmaceuticals & biotechnology, power, communications, transportation, environment and water. CH2M HILL has more than 18,000 employees in offices worldwide.

Congratulations CASA Members:

The results of our Chapter Excellence (CE) for reporting year 2005-06 are in, and I am pleased to report that we improved our scoring considerably from the prior year. In the most recent submittal, CASA Chapter scored 798 of a maximum possible score of 897 points, or 89% of max. This represents a 16.3% improvement over the prior year's score of 686, or 76% of max.

Thank you to all who helped us to meet these Chapter Excellence criteria during the year and to Debora and Dawn at MCI who helped us to compile the report notebook. As anyone with CE experience will tell you, adding 112 more points to our score over just one year is an impressive achievement. Hopefully, with your help, we can continue this positive trend in the coming years as well.

Here is an excerpt from the transmittal email from Lynne Richards at the ISPE-Tampa office:


The Chapter's outstanding commitment and enthusiasm put you on top exceeding all other Chapters with your distinctive support in student development. On behalf of ISPE, I can't thank you and the Board enough. You are dedicated volunteers making the Carolina-South Atlantic Chapter one of the most dynamic group of people representing ISPE's core values.


Lynne Richards
ISPE Director
Affiliate and Chapter Relations


As you can see from Lynne's comments, our Chapter is very highly regarded at the International level. Thank you again for all of your contributions and hard work on behalf of the Chapter.

Merry Christmas, Happy Holidays, and a Happy & Prosperous New Year...

Sincerely,

Martin E. Rock
President & Board Chairman
ISPE - Carolina-South Atlantic Chapter

Press Release

Continued Growth in Life Sciences Market Spurs McDonald-York to Hire Tom Jackson as Manager in the Life Sciences Group.

RALEIGH, NC (September 28, 2006)—Is it "Vivariums" or "Vivaria"? Regardless of the form of the word you choose, McDonald-York, Inc. can construct it for you, as well virtually any type of medical or pharmaceutical lab, computer lab, biohazard facility, clean room, or facility for radioactive research. A leading general contractor specializing in preconstruction and construction services for biotechnology and pharmaceutical companies, McDonald-York recently hired Thomas A. Jackson as Manager in the Life Sciences Group. He will focus on client development and services for life sciences projects.

Presentations from events

Presentations from the September 21st event, "Molecule to Market-place" and the August 16th Chapter Planning Session are now available on the presentations page.

Carolina - South Atlantic Newsletters

A listing of recent newsletters and links to archive newsletters from past years.

Chapter Activities