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Type: News

Section: Industry News > Regulatory

Regulatory

Counterfeiting drugs: Growing, global problem

European market could become portal for counterfeit drugs coming into the United States.

August 10, 2005

Regulatory

Written procedures needed for label verification

According to the regulations enforced by the Food and Drug Administration, "There shall be written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products" (21 CFR 211.130) and "Each manufacturer shall control labeling and packaging operations to prevent labeling mixups" (21 CFR820.120d). Verification of the correct labels can be simple or complex. A labeling process that utilizes preprinted labels affixed during the packaging process may require a simple verification. A more complex verification may be required for a process such as the downloading of product information from an ERP system for the on-line printing of unit labels and cartons that could include printing, reading, and verifying bar codes.

July 10, 2005

Regulatory

Bar-code anticounterfeiting system

July 10, 2005

Regulatory

Equipment qualification

July 10, 2005

Regulatory

Anticounterfeiting and antifraud products

Kevin O’Donnell, Senior Partner, Exelsius, is a noted authority in supply chain integrity. In this Q&A he lends his “big-picture” insights regarding distribution practices for time and temperature-sensitive pharmaceutical/biological products.

July 10, 2005

Supply Chain

Thoughts on FAT

If validation documentation is done earlier, the Factory Acceptance Test (FAT) can be a simple procedure, but not always. "It used to take only a couple of hours to make sure things were running properly during a factory acceptance test, but today it can take eight to 10 weeks to put the equipment and software through the necessary challenges to demonstrate that it will meet today's quality compliance standards," says Bikash Chatterjee, COO of consultancy Pharmatech Associates. "We need to make sure that the equipment will meet all the user and functional requirements, which means we spend more time at the factory where it's more efficient to fix things in the supplier's factory than on the customer's shop floor," he says. "Some customers are doing FATs in factories and are there for weeks on end," says Dave Schuh, VP of sales and marketing at MGS Machine Corp. "But the challenge is to understand the full scope of the FAT requirements, and fit it within the scope of work up front so that everyone wins."

July 10, 2005

Regulatory

More modular software could simplify validation

As smart machines become more prevalent, the process of validating the software becomes more complex. But by making the software modular, manufacturers are further easing the validation process. For instance, a packaging machine might have 20 servo axes, which all use basically the same subroutine. Instead of validating each axis performance individually, could you validate the subroutine once and be done? The manufacturer could hand over the validated modules and documentation, and the process would be complete.

July 10, 2005

Regulatory

Can templates simplify the validation process?

MGS Machine Corp., a packaging machinery OEM with a keen interest in pharmaceutical packaging, is developing templates to help its customers with the validation process. For example, for machines that attach an outsert, MGS provides a five-page template that explains in explicit terms how the machine works, how bad product is rejected from the line, how the machine communicates, and how it verifies that the reject really did happen. Also developing templates is the JETT (Joint Equipment Transition Team) Consortium, a special interest group of the International Society for Pharmaceutical Engineering, created to help ease the cGMP process. JETT aims to improve communication between users and suppliers of automated production and process equipment to meet validation requirements more effectively.

July 10, 2005

Supply Chain

PAT seeks quality by design

The pharmaceutical industry responded to the FDA's cGMP report with Process Analytical Technology, or PAT, a system to design, analyze, and control manufacturing and packaging processes through timely measurements of critical quality and performance attributes. The goal of PAT is to understand and control the processes with the assumption that quality cannot be tested into products, but rather should be built into systems by design.

July 10, 2005

Regulatory

Responding to the FDA's cGMP report

The fundamental process for validation has been in place for 10 years: The pharmaceutical company develops qualifications for a packaging machine, then passes them off to a supplier for equipment designing and manufacturing. After testing and approving the equipment, the pharmaceutical company begins operations. The Food and Drug Administration made this process at once both easier and more difficult last September with its report "Pharmaceutical cGMP's for the 21st Century – A Risk-Based Approach." Current good manufacturing practices (cGMPs), sometimes known as good automated manufacturing practices (GAMP), have long been a standard practice in the pharmaceutical industry, but new technologies and approaches to quality assurance required more flexibility—and thus more variability—in the validation process.

July 10, 2005

Regulatory

Malaysia opts for pharma hologram

A hologram, produced by Hologram Industries (HI), is now being used to authenticate pharmaceuticals throughout Malaysia.

June 10, 2005

Regulatory

Validation efforts need to incorporate machine operators

C.R.S. Ravishankar, a guest from India at IoPP's Chicago Chapter meeting May 10, offers insights into validating pharmaceutical packaging processes.

June 10, 2005

Regulatory

Security and U.S. trade shows

International attendance at U.S. expositions and conferences has taken a hit the last few years due to Homeland Security stemming from 9-11-01. Typically, international visitors decide to attend a show three to four months preceding the event. Visa applications to travel to the U.S. from countries such as China or India can take as long as nine months. So, a packaging machinery or materials company in the U.S. that markets to global prospects has to find new ways to reach these international customers. That heightens the importance of your Web site, and the use of new technology such as Webcasts (see next article).

June 10, 2005

Regulatory

What skills will you need to succeed?

Survey respondents identify knowledge of validation and regulatory issues, as well as materials expertise, as critical.

June 10, 2005

Regulatory

Optical character recognition system

June 10, 2005

Regulatory

Drug import bill could speed RFID adoption

Pfizer and Purdue Pharma are already testing RFID. This year, the Senate will likely pass legislation making it legal for wholesalers to import pharma packaging using RFID tags.

May 10, 2005

Regulatory

Why so little RFID progress in pharma?

If the use of RFID technology makes sense anywhere in the field of packaging, the one place where it should be recognized as an obvious problem solver is in drug packaging. So why has the use of RFID in pharma become so bogged down in unnecessary complexity? Let's first consider the nature of the pharmaceutical industry. Making and packaging drugs is both complex and capital-intensive. It's also heavily regulated and policed by many. On the drug manufacturing side, batch and quality control have long benefited from the use of bar codes that bring order to what otherwise might be chaos. And when it comes to packaging and distribution—to either consumers in the store or professionals at a healthcare facility—we've found ways of promoting brand identity without jeopardizing our ability to comply with labeling regulations. That's the good news. The bad news is that the pharmaceutical industry has had to contend with a grey market for both branded and generic drugs and a black market for diverted drugs. It's also in a quandary over the efficacy of some drugs. Throw in the fact that in some countries the drug supply is fraught with local circumstances involving theft and diversion, and you get a feel for what the drug industry is like.

May 10, 2005

Regulatory

Ross Labs' speaker extols RFID's benefits

Mike Wallace of Abbott Laboratories' Ross Laboratories Division offered multiple RFID insights, including his company's work with Wal-Mart.

May 10, 2005

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