Packaging COP E-Letters

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E-Letters

E-Letters were topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (CoPs). The content for E-Letters was submitted by professionals working in the pharmaceutical industry and was a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems. E-Letters were discontinued in 2013.

*CoPs are an ISPE Member-only benefit; therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing past E-Letter content and other valuable resources that will assist you in being more effective at your job.

November 2013

Packing Line Power Use and Heat Gain
by Martin Wheeler
Learn more about the three approaches used to reduce energy usage in pharmaceutical processes. Read more

July 2013

PMMI and ISPE Partner to Launch Pharma EXPO
PMMI, owner and producer of the PACK EXPO trade shows, and ISPE announced the debut of Pharma EXPO, a new event designed to connect pharmaceutical, medical device and nutraceutical manufacturers with the packaging, processing and other supply chain technologies they need to meet rigorous industry regulations and grow business. The event will debut in 2014 and co-locate with PACK EXPO International (November 2-5, 2014; McCormick Place, Chicago). More.

Sustainable Pharmaceutical Packaging
Learn the key objectives and assessment programs and tools for sustainable pharmaceutical packaging in this new Pharmaceutical Engineering Knowledge Brief. More.

Contract Packaging Update
Big moves are afoot in the contract packaging space, according to Gil Roth of Contract Pharma. In recent months there’s been a major consolidation, new market entrants, expansion among existing players, and a regulatory push that could change the face of the business. More.

Cold Chain Roundtable
How are new software developments contributing to cold chain logistics? How are regulatory movements affecting cold chain technology in biopharmaceutical R&D? Cold chain experts weigh in on these and other issues in a Pharmaceutical Outsourcing article. More.

Proposal of a Disruption Scoring Model for Pharmaceutical Supply Chains
Supply chain disruptions in globalized production and distribution networks have raised many concerns during the last years. Such disruptions can lead to a negative deviation of the process plans and immediate losses of products and reputation. An article in Pharmaceutical Outsourcing proposes a tool to help systematically identify, measure, and analyze disruptions in pharmaceutical supply chains. More.

Pharmaceutical Serialization and Implementation Myths
As the clamor surrounding looming serialization mandates grows louder, it’s become increasingly difficult to separate fact from fiction, according to an author who separates reality from myth in a Pharmaceutical Processing article. More.

April 2013

Help Us Meet the Future Needs of the Pharmaceutical Packaging Industry
The Packaging Community of Practice (COP) Steering Committee is looking for volunteers to provide strategic and tactical leadership for the COP. As a Steering Committee member, you would play an important role in helping the COP meet its annual objectives by contributing your subject matter expertise as well as your personal leadership. We are especially seeking Subject Matter Experts in Serialization and Cold-Chain. The Steering Committee meets via conference calls once a month and face-to-face at the ISPE Annual Meeting. More.

EU Revises Rules on the Distribution of Medicinal Products
Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published in March, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. More.

The Future of Pharma Manufacturing
Editorial advisory board members of Pharmaceutical Technology provide their perspective on the future of bio/pharmaceutical manufacturing in the publication’s January 2013 issue. More.

Seeking Cold Chain Efficiency
Medication safety and efficacy depend on maintaining products at the proper temperature, according to Hallie Forcinio in her article in Pharmaceutical Technology. More.

Building a Sustainable API Supply Chain
An article by Thomas M. Eckrich in Pharmaceutical Outsourcing provides tips for a successful API sourcing strategy. More.

Will California e-Pedigree Dates Slip Again?
No, writes Dirk Rodgers in Healthcare Packaging. He explains his prediction and gives an update on the status of pharmaceutical track-and-trace technology, standards, and regulatory compliance issues. More.

Patient Adherence Goals Drive Walmart’s New Compliance Pack Launch
Walmart and Sam’s 4,600 pharmacies add new sustainable calendar-style packs for select scripts in an effort to improve patient adherence to drug regimens, reports Jim Butschli of Healthcare Packaging. More.

Newly Revised COP Operations Handbook Now Available
The Community of Practice (COP) Operations Handbook has been recently revised to provide guidance on governance, organizational structure, and operational procedures for COPs. The Operations Handbook is intended to serve as a resource for COP Steering Committee Members and local COP leaders, as well as all Volunteer groups or individuals who interact with ISPE COPs. Visit the Volunteer Resources section of the ISPE website to download a copy of the newly revised COP Operations Handbook.

January 2013

Patient Adherence Remains a Challenge for Compliance Packaging
Using packaging to improve patient adherence is a growing market. Several packagers and suppliers share their perspectives on issues and trends in the compliance packaging market in a Contract Pharma article. More.

UPS Releases “Pain in the (Supply) Chain” Survey Results
UPS released results from its recent 2012 Pain in the (Supply) Chain healthcare survey, which reveals specific strategies that pharmaceutical, biotech, and medical device companies are employing to bolster their supply chains over the next three to five years, according to an article in Contract Pharma. More.

The Most Common Problems in Pharmaceutical Mail Order Shipments
An article in Pharmaceutical Outsourcing presents the most common problems seen over the last 20 years in the mail order pharmaceutical industry. More.

California e-Pedigree Compliance Update
California’s e-pedigree law could ultimately create a de facto standard for unit-level serialization and track-and-trace of individual prescription drugs. On the other hand, if a US federal rule is issued, that rule could largely preempt California and other states, according to an article in Healthcare Packaging. More.

More Articles on Supply Chain

October 2012

Pharmaceutical Engineering Features Trends, Issues, and Innovative Approaches in Product Packaging
The September/October 2012 issue of Pharmaceutical Engineering includes articles on evolving trends, issues, and innovative approaches in product packaging. Topics include adherence packaging, serialization implementation, Brite Stock Manufacturing, and serialization coding solutions. This issue also includes articles on microparticles for gene delivery, upstream/downstream data analysis for Quality by Design, product lifecyle management, and the use of Non Investigational Medicinal Products in global clinical trials. More.

Top 20 Supply Chain Management Software Suppliers
Modern Materials Handling’s annual look at the supply chain software market revealed that the industry grew significantly in 2011. More.

Preventing Cargo Theft
An article in the August 2012 issue of Pharmaceutical Technology discusses strategies for a proactive cargo security and antitheft program, including best practices used by Pfizer. More.

Robots Make Inroads in Packaging
The cover story of the August 2012 issue of Packaging World looks at how several industries, including pharmaceuticals, employ robots in packaging for their speed, functionality, efficiency, and accuracy. More.

Sustainable Packaging
The July 2012 issue of Packaging World includes a section on sustainable packaging looking at cost reductions from adopting sustainable practices and biodegradable foam. More.

FDA’s Proposed Regulation on UDI’s Available for Comment
The US FDA has proposed regulation that would require labels of most medical devices and device packages to feature a Unique Device Identifier (UDI) in an effort to aid with corrections and recalls and to help thwart counterfeiters. Deadline for comments is 7 November 2012. Highlights of the proposed regulation are discussed in an article in the July 2012 issue of Healthcare Packaging. More.

News in Blister Packaging
Several articles in the June 2012 issue of Pharmaceutical & Medical Packaging cover developments in blister packaging materials. More.

July 2012

ISPE Releases Industry’s Only Guidance on Building Packaging, Labeling and Warehousing Facilities
The ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities is the industry’s only guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities. The Guide, published in June, helps companies meet CGMP requirements for these types of facilities while avoiding product adulteration, product mix-up, label mix-up and misbranding. Companies can use this Guide to learn how to ensure that their PACLAW processes are efficient, compare their processes to established best practices and demonstrate compliance to regulatory agencies. More.

Get the Basics of Blow/Fill/Seal (B/F/S) Technology
The new ISPE Knowledge Brief, Packaging Equipment: Blow/Fill/Seal (B/F/S) Technology, provides a basic introduction to this B/F/S technology and discusses how it may be suited for pharmaceutical filling applications. It provides a basic guidance for what is required to install a system and what complementing utilities, cleanrooms, environmental conditions, and inspection equipment may be considered. More.

Good Practices for Controlled Temperature Chamber Mapping
An ISPE Concept Paper on Controlled Temperature Chamber Mapping describes good practices for the mapping of controlled temperature chambers, warehouses, and refrigerated storage areas used in the pharmaceutical and biopharmaceutical industries. The Packaging COP intends to discuss this topic at the 2012 ISPE Annual Meeting. More.

Using Closed-Vial Technology in Aseptic Filling
An article in Pharmaceutical Technology by ISPE Member Benoit Verjans discusses how closed-vial technology is an alternative to traditional glass vial filling that reduces the risk of contamination for the patient, simplifies the filling process, and provides easier handling for healthcare providers. More.

Temperature-Sensitive Pharma Concerns
An article in Contract Pharma discusses the 10 most common supply chain pitfalls for temperature-sensitive pharmaceutical products. More.

Mobile Technology Ensures Drug Authenticity
An article in Packaging Digest discusses Mobile Product Authentication (MPA) technology which allows consumers to verify a product’s authentication at the time of purchase or use, using unique identifiers or codes on each package and text messaging. More.

April 2012

Share Your Knowledge of Innovative Drug Delivery and Packaging in Pharmaceutical Engineering
The Packaging COP is seeking Subject Matter Experts to help write technical articles addressing hot topics for the September/October 2012 issue of Pharmaceutical Engineering. This issue will include articles that feature fill and finish operations and a myriad of the evolving needs of product packaging. Innovative drug delivery systems, involving new processes, new equipment, and green packaging concepts, in addition to packaging operations of the future could be explored in detail. Articles focusing on serialization matters, packaging safety, machines and controls integration, and related labeling needs could be possible features. More.

Expanding Capabilities in the Pharmaceutical Cold Chain
As biopharmaceutical development and commercialization increases, companies are expanding their cold chain capabilities, according to an article in the February 2012 issue of Pharmaceutical Technology. More.

The Glass Quandary
An article in the January/February 2012 issue of Contract Pharma discusses how glass breakage, delamination, and compatibility with biologics have boosted interest in novel materials in pharma packaging. More.

“Voices of Leadership” Focus in Healthcare Packaging
The February 2012 issue of Healthcare Packaging provides perspectives on developing packaging trends and issues from Packaging Hall of Fame inductees and other pharmaceutical and medical device industry leaders. More.

Avoid Bad Air Days
An article in the January 2012 issue of Plant Services looks at the reliability of compressed air systems. More.

Private View: Breaking the Healthcare Barriers
Each month, a creative director in the industry provides insight into the world of advertising for the “Private View” column in Medical Marketing & Media. The March 2012 column reviews convincing ads for a blood donation campaign, a flu vaccine, and common over-the-counter products. More.

January 2012

Using OEE for Packaging Line Improvement
This new ISPE Knowledge Brief describes the concept of Overall Equipment Effectiveness (OEE), the metrics used in OEE, the basics of conducting an OEE study, and how to implement OEE improvement for operations associated with a primary or secondary packaging line located in a pharmaceutical area. More.

All About Supply Chain and Cold Chain
The October 2011 issue of Contract Pharma focuses on Supply Chain while the magazine’s September 2011 focus is on Cold Chain.

Examining the Outsourcing Relationship
The BioPlan Associates 8th annual survey examines trends in the outsourcing relationship. An article in BioPharm International discusses the results of the survey, which identifies key outsourcing concerns of sponsor companies and contractors. More.

Managing the Global Clinical Trial Material Supply Chain
An article in Pharmaceutical Technology discusses how the increase in the number of developmental compounds, greater complexity in clinical trials, and an expansion of clinical trial sites globally are raising the bar in managing the Clinical Trial Material (CTM) supply chain. More.

 

October 2011

Available for Comment – Revised EU Guideline on Good Distribution Practice of Medicinal Products for Human Use
First published in 1994, the guideline was revised to take into account developments in the storage and distribution of medicinal products in the European Union and to meet new requirements for wholesale distributors and brokers established in the new Directive 2011/62/EU on falsified medicines. Comments are due by 31 December 2011. More.

ISPE Comments on Proposed Revisions to USP Chapter 1079, Good Storage and Shipping Practices for Drug Products
The ISPE Packaging Community of Practice (COP) and members of other interested COPs contributed comments on proposed revisions to USP Chapter <1079> Good Storage and Shipping Practices. More.

American Airlines Cargo Expands Options for Shippers of Temperature-Sensitive Pharmaceuticals
American Airlines announced the expansion of its cold-chain service, ExpediteTC(SM), to include a new solution for the requirements of cold packaging during transit, according to Healthcare Packaging.com. The new solution supports ambient temperature control using state-of-the-art cool rooms, expedited handling processes, and high-visibility monitoring to ensure cargo is handled within desired temperature ranges. More.

Approaches to Offset Rising Fuel and Distribution Costs
The May/June 2011 issue of Pharmaceutical Outsourcing features an article by Ray Goff, Director, Pfizer Vaccines R&D on “Approaches to Offset Risking Fuel and Distribution Costs.” Goff discusses how two trends, new cold chain (temperature sensitive) products and the overall growth in the number and size of clinical studies, explain why rising fuel prices are important to the pharmaceutical industry. Registration for a free subscription is required in order to view the complete article. More.

9th Annual Cold Chain and Temperature Management Global Forum
The 9th Annual Cold Chain and Temperature Management Global Forum was held 26-30 September 2011 at the Pennsylvania Convention Center in Philadelphia, PA, USA. The forum examined the modern cold chain – including all temperature range products and their regulatory requirements – as well as evolving sectors such as medical devices and diagnostics, generics, APIs, clinical and biologics and cell therapies. Registration for a free subscription to Pharmaceutical Outsourcing is required in order to view the complete article. More.

Big Pharma’s Manufacturing Blueprint for the Future
The pharmaceutical majors continue rationalizing manufacturing capacity in established markets as they forge their manufacturing networks in biologics and emerging markets, according to an article in Pharmaceutical Technology. More.

Top 1,000 Biomanufacturing Facilities
BioPharm International’s June 2011 and August 2011 issues both feature the top 1,000 biomanufacturing facilities from around the world.

Search Parties
Does the battle for social supremacy being waged by Google, Facebook, and Bing make this medium more or less viable for pharma marketers? An article in Medical Marketing & Media explores. More.


July 2011

Now Available – ISPE Good Practice Guide (GPG): Cold Chain Management
This GPG covers a wide range of topics, including facilities, fixed cold rooms and freezers, temperature controlled shipping equipment, as well as guidance on mapping and monitoring, featuring practical technical guidance in all these areas, as well as addressing maintenance and cleaning. The guide also includes an introduction to product traceability. Cold chain is an area with increasing challenges to manufacturers, as the volume of products requiring controlled temperatures and the complexity of the supply chain for those products increase. The GPG provides practical guidance and examples of typical documents in the area of cold chain management. More.

CDISC Clinical Research Glossary
The latest version by Applied Clinical Trials Online provides hundreds of definitions for key terminology related to clinical research. More.

Fighting Fakes with Technology
Counterfeiting, diversion, the resale of expired products, and complexities within the supply chain are forcing the healthcare industry to seek ahead-of-the-curve security packaging, according to the article, “Tech Beats Security Breach,” in Pharmaceutical & Medical Packaging News. More.

Rental or Leasing of Reusable Package Shippers
The March/April issue of Pharmaceutical Outsourcing features the article, “A Rental or Leasing Program for Small Reusable Package Shippers for Temperature – Controlled Products.” Registration for a free subscription is required in order to view the complete article. More.

Merck’s First Virtual Symposium – Is This the Future for Us All?
Merck & Co. in collaboration with ProtonMedia created a 3-D virtual symposium and interactive poster session that was able to supply measurable knowledge transfer, and meet and/or exceed what was demanded of an in-person event, according to an article in the April issue of Pharmaceutical Executive. More.

New Risk-MaPP Resources: Blog and FAQs
ISPE published the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in September 2010. The Guide provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. The Guide has generated much discussion. In response to industry needs, ISPE has set up a blog and developed an FAQ document dedicated to the issues related to the Risk-MaPP Baseline Guide. More.
 

April 2011

New Risk-MaPP Resources: Blog and FAQs
ISPE published the Baseline® Guide: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) in September 2010. The Guide provides a scientific risk-based approach, based on ICH Q9 Quality Risk Management, to manage the risk of cross contamination in order to achieve and maintain an appropriate balance between product quality and operator safety. The Guide has generated much discussion. In response to industry needs, ISPE has set up a blog and developed an FAQ document dedicated to the issues related to the Risk-MaPP Baseline Guide. More.

FDA Talks Track-and-Trace with Industry
An article in Healthcare Packaging provides the highlights from the FDA’s track-and-trace workshop with drug company executives held in February. More.

Magazine Issue Focuses on Supply Chain
Contract Pharma’s January/February edition focused on supply chain. Here are selected articles that may be of interest:

Resource for Articles on Anti-Counterfeiting, Track and Trace, and Authentification
Healthcare Packaging has a collection of articles reporting on the issues and trends involved in battling counterfeiting and diversion, reporting on technologies such as RFID, bar coding, holography, DNA, nanotechnology, and taggants, etc. More.

A Million-Plus Reasons to Value the Pharmaceutical Cold Chain
An article in Healthcare Packaging reports on the 8th Cold Chain Distribution for Pharmaceuticals Global Forum in Philadelphia. Read more.

Defining Test Practices
An article in Pharmaceutical & Medical Packaging News discusses the new ASTM standard for climatic stress testing of small parcels. Read more.

Articles Focus on Cold Chain
The November/December 2010 issue of Pharmaceutical Outsourcing includes a couple of interesting articles related to cold chain. Registration for a free subscription is required in order to view the complete article.

Spring 2011 Issue of Tracking and Tracing Pharmaceutical Products Released
The Spring 2011 copy of Tracking and Tracing Pharmaceutical Products includes the latest developments in ePedigree management, RFID, supply chain and package security technology. Read more.

ISPE Cold Chain Good Practice Guide
In response to ISPE Members’ call for a reference that provided practical engineering advice related to Cold Chain, ISPE will publish the ISPE Good Practice Guide: Cold Chain Management in the second quarter of 2011. The Guide contains sections covering facilities, fixed equipment, portable equipment and packaging, mapping and monitoring, selecting locations for temperature monitoring equipment, maintenance and cleaning, as well as an introduction to product traceability. The Guide provides information on risk-based approaches to equipment qualification and ongoing monitoring strategies.
 

January 2011

Pharmaceutical Cold Chain: A Gap in the Last Mile
According to USP Chapter <1079> Good Storage and Shipping Practices, “a drug can take a variety of paths from the manufacturer to the patient. In the simplest form of the distribution system, the manufacturer ships directly to the customer, such as a doctor’s office, clinic, or hospital. However, more often, the article leaves the manufacturer’s chain of control and enters a complex system of handoffs that involve the distribution chain to the patient.” An article in Pharmaceutical & Medical Packaging News discusses temperature monitors; when to use what; and the latest technology vs. misinformation. Read more.

A Closer Look at Security and Identification
The November 2010 issue of the Technology First Journal includes an update on RFID applications. Read more.

China’s State Food and Drug Administration Discusses Drug Applications
An article in the November 2010 issue of Pharmaceutical Technology provides a Q&A with officers of the departments of State Food and Drug Administration in China. Read more.

Automated Inspection of Pharmaceutical Products
The November 2010 issue of Pharmaceutical Technology also includes an interesting discussion on the possibilities for conducting fully automated product inspections. Read more.

Go East Young Man, With Caution
The cover story of the November 2010 issue of Pharmaceutical Formulation & Quality (PFQ) explores the inter-relationships between the US and China. Read more.

Sales Force Report Pharma's Got a Brand New Bag
For engineers interested in a glimpse into another world, Medical Marketing & Media’s November 2010 issue includes an interesting report on the changing face of sales and marketing. Read more.

ISPE Cold Chain Good Practice Guide
In response to ISPE Members’ call for a reference that provided practical engineering advice related to Cold Chain, ISPE is expected to publish the ISPE Good Practice Guide: Cold Chain Management in the first quarter of 2011. The Guide contains sections covering facilities, fixed equipment, portable equipment and packaging, mapping and monitoring, selecting locations for temperature monitoring equipment, maintenance and cleaning, as well as an introduction to product traceability. The Guide provides information on risk-based approaches to equipment qualification and ongoing monitoring strategies.

ISPE also intends to produce guidance on product distribution. If this is a topic that interests you or you know someone who may be interested, please contact Nick Haycocks.