ISPE's Packaging Community of Practice addresses MES, compliance issues

Manufacturing Execution Systems (MES) aim to support production processes in a plant.


But in the area of life sciences, "packaging systems are way behind" compared to other production areas. "Packaging is a poor sister trying to keep up," said Gregory Ruklic, principal engineer, Technology & Compliance, Biotech Technology & Engineering with Wyeth Pharmaceuticals, Wilmington, MA. Ruklic made a presentation at an October 27 dinner meeting of the International Society for Pharmaceutical Engineering's (ISPE) Packaging Community of Practice (COP). The event was held at 32 East in Delray Beach, and led by COP co-chair Linda McBride, vice president, regulatory affairs for Cogentus Pharmaceuticals in Menlo Park, CA. McBride noted that Chuck Reed (shown here) of Weiler Engineering is the COP's incoming chairperson. MGS Machine founder Mel Bahr delivered a presentation involving compliance issues, noting that material suppliers and contract packagers are leading the way in package development in this area, "with not a lot coming from end-user companies."

Bahr explained that Walmart, Target and other retailers are pushing the envelope regarding patient compliance packaging. Costs are a big factor as the "big-box" companies market $4 presciptions and look to drive out costs throughout their supply chains, packaging included. To meet the market's compliance needs, Bahr recommended package designers/suppliers, equipment manufacturers, and end-user firms develop a three-way collaborative effort.

Bahr provided a brief look at the Joint Equipment Transition Team, or JETT. On its Web site, JETT is defined as "a consortium of healthcare Industry users (manufacturers), equipment suppliers, and consultants seeking to improve communications between users and suppliers to more effectively meet the validation requirements of the healthcare industries." Bahr said JETT works to transition noncompliant packaging lines to validated lines. JETT is part of GAMP Americas within ISPE.

Wyeth's Ruklic discussed GAMP-related issues as well. He also pointed out that it's important that automated systems used within a plant be as functional as possible. With packaging machinery, he advised companies to get data out of individual machine systems and into a broader enterprise system as soon as possible.

A closer look at the Packaging COP

Weiler's Reed provided the following article describing ISPE's COP, which now numbers more than 800 since it was started June 1, 2007:

The COP provides an interactive virtual community for pharmaceutical industry professionals working in the packaging arena. The COP is a dynamic forum for professionals in packaging who are seeking relevant and timely information to discuss and address issues of common interest. Serving members from all facets of multi-disciplined packaging arenas, the Packaging COP provides a platform for the exchange of information on labeling, warehousing, components, and equipment.

The Packaging COP is specifically designed for professionals in the areas of packaging for pharmaceutical, biotech, and medical device products including packaging equipment specialists, technical specifications writers, packaging material engineers, contract packagers, and procurement professionals. Management personnel involved with facility oversight and pharmaceutical product supply chain responsibility will find the Packaging COP a helpful resource.

Education is a key focus of the Packaging COP, which assists in the development of technical documents and white papers and the creation and delivery of training on current hot topics such as e-pedigree and sustainability. An educational syllabus has been developed within the COP that includes program presentations and networking events at upcoming ISPE meetings and conferences, on-line webinars and the production of key publications such as the Packaging, Labeling and Warehousing Baseline Guide.
The Packaging COP provides benefits to its members through the following opportunities within the area of packaging:

• Opportunities to become actively involved and help determine the focus of the Packaging COP

• Training and conferences on packaging-related topics

• An electronic discussion forum to allow questions and answers on industry topics between COP members, including authors of our publications

• A newsletter communicating current activities to members

• Publications and articles related to packaging

• Opportunities to share knowledge and experience with other like-minded professionals

• Ability to positively influence the pharmaceutical manufacturing profession

• Tools to enhance productivity and keep current with industry trends and developments, including e-letters and e-discussions

• Convenient and efficient global networking opportunities

• Membership to the Packaging COP is free to ISPE members. Access to full benefits is available to ISPE members. If you would like to get involved or have comments and suggestions, please go to the link at and click on the Communities of Practice tab.