Your source for news, trends and analysis of pharmaceuticals, biologics, medical devices, and nutraceuticals.

To no one’s great surprise, the California Board of Pharmacy voted March 25 to postpone until 2011 a law requiring that prescription drugs be electronically tracked from the time they leave the manufacturer to the time they reach the pharmacy. First enacted in 2004, the law’s original deadline was January 2007. That deadline was pushed back to January 2009, and now it’s been pushed back again. Included among the reasons for the decision was the concern that implementation might be done poorly.

Watch for pharmaceutical manufacturers to employ robotics more frequently to boost efficiencies throughout their processing and packaging operations. “We may be ‘OnTheEdge’ of a major growth spurt for robotics on North American packaging lines,” notes Keith Campbell, consultant and OnTheEdgeBlog.com blogger. “Mechatronics and robotics are two ‘disruptive technologies’ that have the potential to transform the development of packaging equipment,” adds Ben Miyares, vice president of industry relations for the Packaging Machinery Manufacturers Institute.

“It really is about time we got some form of e-pedigree system in place” for drug products, states Bryan Liang, law professor, medical professor, and Vice President of the Partnership for Safe Medicine.
He describes the Partnership for Safe Medicine as “a group of organizations and individuals dedicated to ensuring the safety of the drug supply,” including physician, pharmacist, university, industry, and other professional organizations. The partnership has been heavily involved in advocating for a pedigree system to thwart counterfeiting and diversion, but it wants a workable system.

Synchronized lines, rather than individual pieces of equipment, will be a focus of pharmaceutical manufacturers, predicts PMMI’s Ben Miyares. In this exclusive Q&A interview with Healthcare Packaging, Miyares addresses multiple healthcare packaging-related issues, including mechatronics and robotics, which, he says, "have the potential to transform the development of packaging equipment." He also looks at sustainability, packaging equipment purchase considerations, E-machinery, and counterfeiting topics.

Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.

When cosmetic product labels tout benefits similar to those of drugs, there’s likely to be trouble. ...When is a cosmetic not a cosmetic? When it’s a drug. A review of Food and Drug Administration Warning letters for the last few years reveals some of the alleged problems involved in the marketing of cosmetics.

Panelists from McKesson Corp., Pfizer Pharmaceuticals, Amerisource Bergen Corp., and Ahold USA recognize that while radio-frequency identification (RFID) offers promise in the pharmaceutical sector, its adoption raises questions. That message came through loud and clear at a recent gathering at the EPC Connection event, held in Chicago in October.

Healthcare Packaging and Packaging World, producers of the Pharmaceutical Packaging Forum, and Ipack-Ima Spa, organizers of Pharmintech, announce a cooperative agreement in which Healthcare Packaging and Packaging World will offer promotional support to Ipack-Ima Spa, increasing the visibility for their Italian trade event, Pharmintech, to the U.S. pharmaceutical market. Pharmintech, held every three years in Italy, will next take place May 12th -14th, 2010 in Bologna, Italy.

Wyeth’s Charlie Portwood and Teva Global Generic Resource’s Uri Boneh will serve among the keynote speakers at The International Society for Pharmaceutical Engineering’s (ISPE) annual meeting Nov. 4 – 7 at Caesars Palace in Las Vegas. The event will feature more than 40 sessions, with topics including packaging, product quality lifecycle implementation, pandemic flu preparedness, personalized medicine, nanotechnology, disposables, and project management.

A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In the FDA Amendments Act of 2007, little-noticed section 913 adds a new section to the law called "Pharmaceutical Security" that calls for federal government officials to "develop standards and validate effective technologies" to secure the drug supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."

If cGMPs do their job right, then dietary supplements will be packaged and labeled correctly.

If you are a packager of dietary supplements, you may have a strong reaction to the new Food and Drug Administration regulations setting current Good Manufacturing Practices (cGMP) requirements for these products. These regulations were announced by the FDA in late June and can be found in 21 CFR Part 111.1 – 111.610. As a maker of these products, you might welcome the level playing field among supplement companies that these new manufacturing controls can bring, as well as the higher consumer confidence in products of this type that may follow from more consistent quality. Or, you may resent the rules’ irritating new burdens in procedures and record keeping.

“With the rapid growth in the biopharmaceutical industry over the past two decades, the number of newly approved biological products has dramatically increased. In 2005, a record 21 biological products received U.S. Food and Drug Administration approvals, including therapies for the treatment of rheumatoid arthritis, diabetes, cancer, and rare genetic disorders,” says the Intl. Society for Pharmaceutical Engineering (ISPE). With that in mind, the organization has released the ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products .

The recent rash of news about quality and identity issues involving a broad range of products imported from China has companies and consumers wondering. Counterfeit drugs and other products have recently been the subjects of one or another problem. China has been recognized by companies, the Food & Drug Administration, and other governments as a problematic source of counterfeit drugs for years. So what's the answer, are Chinese products and ingredients immediately suspect?

The FDA's new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling.

The Food & Drug Administration’s new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling. A decade in the making, the CGMP rule, compliance with which will be phased in according to size of company, sets minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers, personnel hygiene on the packaging line and much more, all within the context of forcing the industry—some of which may already be in compliance—to adopt the kind of CGMPs that the FDA has prescribed for food and drugs.

Based in Las Vegas, Med-Health is a combination of three independent businesses where Enterprise Resource Planning (ERP) technology from SAP will play a key role. Currently operating is a Med-Health business that sells medical supplies like gowns, gloves, sutures, and other "consumables." Opening this summer was a pharmaceutical drug wholesaler. And some time around January of 2008 will be the opening of a Med-Health pharmaceutical repackaging arm.

The golden state's ePedigree requirement may force the Food and Drug Administration's hand on the use of radio frequency identification.

A New York federal court’s invalidation of some aspects of the U. S. Food and Drug Administration’s drug pedigree requirement has not dampened the push being made by many pharmaceutical manufacturers to quickly get a handle on the complexities of item-level RFID tagging. Both manufacturers and wholesalers are motivated as much by California’s January, 2009, ePedigree requirement as the FDA Pedigree dictate, which would have required many smaller wholesalers without formal, manufacturer contracts to get detailed product information from manufacturers and pass it down the supply chain, step-by-step.

Read three separate reports from February’s Medical Device & Manufactur-ing show in Anaheim covering:

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans.

Late last year, the International Society for Pharmaceutical Engineering (www.ispe.org) introduced a new packaging Community of Practice (COP). The COP held its first meeting at ISPE's annual meeting in Orlando, FL. Chairing the packaging COP's Steering Committee is Linda McBride, senior director of regulatory affairs for Leawood, KS-based medical firm Enturia, Inc. (formerly Medi-Flex). McBride is a former columnist for Healthcare Packaging.

Ketek (telithromycin) is an antibiotic first approved by the Food and Drug Administration in 2004. The Sanofi-Aventis product used to treat a form of pneumonia is the subject of ongoing controversy, with some fingers pointing at the company and some at the FDA.

Packaging World and Healthcare Packaging columnist and attorney-at-law Eric F. Greenberg offered a list of key issues pertaining to healthcare packaging during the Pharmaceutical Packaging Forum. To read the complete story, please click here.

At the Pharmaceutical Packaging Forum, Attorney Eric F. Greenberg revealed key Food and Drug Administration issues pertaining to healthcare packaging. Among them were drug safety, inspections, cGMPs, labeling of prescription and OTC drugs, and how a unique coalition came together last year to lobby for more FDA funding.

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show.

Late last year, the International Society for Pharmaceutical Engineering introduced a new packaging Community of Practice (COP). The COP held its first meeting at ISPE's annual meeting in Orlando, FL. Chairing the packaging COP's Steering Committee is Linda McBride, senior director of regulatory affairs for Leawood, KS-based medical firm Enturia, Inc. (formerly Medi-Flex). McBride is a former columnist for Healthcare Packaging.

Jan Gates, principal packaging engineer at Abbott Vascular, offered the following advice during her presentation, "Medical Device Distribution Package Testing," during the Medical Device & Manufacturing (MD&M) West show.

The Food and Drug Administration continues to be challenged by limited financial resources. That was one of the messages from Donald E. Marlowe, FDA agency standards coordinator, during his March 8 keynote address that launched this year’s HealthPACK medical device conference in New Orleans. “Packaging is one of the most important issues in designing medical products,” Marlowe told an audience that by unofficial count was about 160. He also said “packaging contributed to the largest number of product failures,” although not recalls. The problems included mislabeling and seal failures.

Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show .

Spend an educational day with your peers and solution providers at the Pharmaceutical Packaging Forum (PPF) in Philadelphia March 29. The event is produced by Summit Publishing Company, publishers of Healthcare Packaging and Packaging World business publications. Seats are going quickly, so register soon.

Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney, “Make Your Move: Taking Clinical Trials to the Best Location.” The report cites China as the best bet for outsourcing clinical trials.

Need to get on the same page with your supplier(s) and consultant(s) in commissioning and qualifying packaging machinery? Try boarding the Joint Equipment Transition Team , or JETT. A small team of end users, suppliers, and consultants finalized the language and a complex diagram for a JETT equipment acquisition model that’s been in the works for more than a year during a January 18 meeting hosted by Abbott Laboratories at its Waukegan, IL, facility.

Drug delivery devices, advances in combination products, and biologics/biopharmaceuticals will present both challenges and opportunities for packagers. New packages and drug delivery methods for over-the-counter (OTC) drugs, nutraceutical and cosmeceutical products are appearing on retail drug and grocery store shelves. (Part II of II)

The packagers of over-the-counter drugs (OTC) and dietary supplements will soon need to label their products with contact information to allow consumers to report possible injuries or illnesses. The packagers, in turn, will have to report serious adverse events to the Food and Drug Administration, and keep records of the events. The law goes into effect one year from President Bush's recent signature.

--By Eric Greenberg, Attorney-at-Law

According to a report posted on DrugResearcher.com , the Government Accounting Office has warned the pharmaceutical industry that although their investment in research and development has increased 147% between 1993 and 2004, New Drug Applications have only risen 38%.

The packagers of over-the-counter drugs (OTC) and dietary supplements will soon need to label their products with contact information to allow consumers to report possible injuries or illnesses. The packagers, in turn, will have to report serious adverse events to the Food and Drug Administration, and keep records of the events. The law goes into effect December 22, 2007.

Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.

Some guys in government service wait until they are actually in office to be the subject of controversy. Andrew von Eschenbach got a head start.

In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes “highlights” of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, “These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products.”

At a June 6 Medical Design & Manufacturing East conference session, Food and Drug Administration regulatory policy analyst Arthur Yellin offered the following advice on medical device labeling:

Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as:

• Who should test the packaging suppliers’ seals?

• Who is responsible for validating package sealing equipment?

• Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?

$199.00 ... The cost for the Institute of Validation Technology’s Special Report: An FDA Conference Report. The volume covers everything from validation to risk assessment to cGMP compliance to what’s expected during an FDA inspection.

Approval and publication of a revised ISO 11607 standard was expected this month, incorporating the provisions of the EN 868-1 standard. (Part I of II)

The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments.

Medical device manufacturers and packaging professionals should take note of the upcoming revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package validation. Many terms have been added or eliminated from the current standard, including the following:

• The definition of “medical device.” ISO 11607-01 includes some medical devices that were not previously covered by the old standard.
• “Primary package” is replaced by “sterile barrier system,” defined as the “minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of end use.”
• “Final package” is replaced by “package system,” defined as “[the] combination of the sterile barrier system and protective package.” This combined package could include the second sterile barrier, or outer package, in a dual pouch or tray; a paperboard carton or shelf box; and the shipping container. These all may combine to form the “package system.”
• The elimination of “package integrity,” which was defined as “unimpaired physical condition of a final package.” Now it is implied that package integrity is lost if the sterile barrier system is breached or does not “prevent the ingress of microorganisms to the product.”