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Validation, compliance and documentation

Stories that report on the information and documentation involved in complying with verification, qualification, and validation guidelines and regulations from agencies and organizations, including quality-related issues.

A change of course for pharmaceutical manufacturing

The FDA’s Quality-by-Design initiative holds potential to transform the pharmaceutical industry’s approach to drug development and manufacturing....

Machine vision inspection system

• IMprints™ CodeMatch enables pharmaceutical companies to begin building an e-Pedigree-compliant packaging line system • this addition to the IMprints Track & Trace Solutions suite provides a range of inspection tools for validation and verification of label information •...

Blister documentation package

• comprehensive Quality Documentation Package comes at no charge with every set of the company’s blister tooling • includes everything necessary for tooling validation, including inspection documents, material data sheets, and material safety data sheets • a similar package...

Bauer’s pharmaceutical handbook lends ‘Hall of Fame’ packaging perspective

Professionals and students will benefit from an informative research tool now available for the healthcare packaging community....

ESD-safe packaging considerations for microprocessor-driven medical devices

Medical and pharmaceutical professionals must adhere to protective measures in safeguarding ESD-sensitive devices against electrostatic discharge....

GlaxoSmithKline, Abbott, and contract packaging panel highlight Pharmaceutical Packaging Forum

The third-annual Pharmaceutical Packaging Forum (PPF) will deliver information you can use on pharmaceutical package design, increasing quality and productivity, patient compliance, strategies to combat counterfeiting, how to increase packaging line profitability, and will include a contract packaging panel, and...

Three testing tips for medical device packages

Sterile medical device package testing is a requirement for compliance to ISO 11607 "Packaging for Terminally Sterilized Medical Devices", Part 1: Requirements for materials, sterile barrier systems and packaging systems, and Part 2: Validation requirements for forming, sealing and...

Cost pressures cloud healthcare packaging's future

Mounting financial pressures top a list of issues driving the pharmaceutical, biologic, and medical device sectors. In an exclusive interview, Freedonia senior healthcare consultant Bill Martineau discusses where packaging fits into these issues. Even before the recent global financial...

Packaging vaccines for pandemic flu or bioterrorist attack: Are we ready?

A Congressional blue-ribbon panel believes, "Terrorists are likely to use a weapon of mass destruction somewhere in the world in the next five years," according to a Dec. 2 CNN report. Biological weapons are more readily available than nuclear...

Podcast: Serialization matters: What pharmaceutical packagers need to know

In this exclusive podcast from Pack Expo 2008, Anne Marie Mohan, senior editor of Packaging World, speaks with Bruce A. Harder, Systech International's director of business development. Harder provides an overview on what constitutes a complete serialization solution and...

CHPA issues voluntary pediatric cough and cold label updates

"Throughout the 2008-2009 cough and cold season, manufacturers will be transitioning onto store shelves oral pediatric cough and cold medicines with new labels and packaging. As with other OTC [over-the-counter] labeling changes in the past, FDA [U.S. Food and...

Seven essentials for successful medical package design and validation

Individuals responsible for medical device packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end user without incurring defect or risk to patient safety. In this...

Covidien counts on machinery and materials in the packaging design equation

The relationship between packaging machinery and materials matters in the package design equation, where global brand owners face the challenge of making their product stand out on the shelf. In this question-and-answer article, Kevin Mulligan explores how this relationship...

Roche goes green, saves greenbacks

A change to more readily recyclable fiberboard for its Boniva® (ibrandronate sodium) prescription-only osteoporosis wallet pack is yielding economic and environmental benefits for Nutley, NJ-based Roche, a division of Swiss pharmaceutical giant, the Roche Group (F. Hoffmann La Roche,...

Track-and-trace mandate could be costly

Implementing track-and-trace technology to help safeguard the U.S. pharmaceutical supply chain from counterfeit drugs could cost pharmacies between $84,000 and $110,000 per store in the first year alone. That was learned from a study on the safety of the...

Laying down the (packaging) law

The Food and Drug Administration is under fire as never before. Environmental law developments around the globe continue to expand and become more complex. Properly coded packages are helping federal, state, and local governmental organizations get to the root...

Catalent expert addresses turnkey serialization

Maintaining electronic pedigrees of your pharmaceutical products through the distribution chain is a challenge for most manufacturers. Now imagine tracking products for and with about 250 pharmaceutical companies. That's the task that will face Somerset, NJ-based Catalent Pharma Solutions,...

'Bloodhound' bites into counterfeiting and diversion

Last September, Summit VetPharm, a subsidiary of Sumitomo founded in 2006 and based in Ft. Lee, NJ, went commercial with a track-and-trace bar-code technology called Bloodhound that's designed primarily as a means of detecting when Summit's Vectra 3D flea-and-tick...

Injectable pharmaceutical processing and packaging evolves

Through the years, there has been little change in the appearance of packaging materials and components in delivery systems for injectable drugs. The material science and manufacturing technologies that go into the creation of these systems, on the other...

Uncover your potentially dangerous documents

Some well-known pharmaceutical and medical device companies have paid substantial fines as a result of hastily written, overly candid, or poorly worded emails and documents containing inappropriate statements. Had their employees been trained how to write complete and accurate...

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