Is Industry Failing to Learn From Past Quality Mistakes?

 Written by Nancy Tomoney - Associate Validation Manager, QPharma

For several years now the FDA has not only published Warning Letters, but also significant Form 483’s in an attempt to educate industry on commonly observed issues.  It seems a portion of industry isn’t paying attention, as there are common problems being repeated over and over again throughout the industry at unrelated companies.  In looking at both Warning Letters and Form 483s available to the public, the questions are raised:

•    Is industry focusing too much on the risk-based approach and not enough on true compliance? 

•    Are we more concerned with profit than with quality?

•    Why are we not learning from the mistakes of others?

In 2002, the FDA issued Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century — A Risk-Based Approach.  The document outlined these goals:

1. Encourage the early adoption of new technological advances by the pharmaceutical industry;
2. Facilitate industry application of modern quality management techniques, including implementation of quality systems approaches, to all aspects of pharmaceutical production and quality assurance;
3. Encourage implementation of risk-based approaches that focus both industry and Agency attention on critical areas;
4. Ensure that regulatory review, compliance, and inspection policies are based on state-of-the-art pharmaceutical science;
5. Enhance the consistency and coordination of FDA's drug quality regulatory programs, in part, by further integrating enhanced quality systems approaches into the Agency’s business processes and regulatory policies concerning review and inspection activities.

It seems every few years another company ends up in Consent Decree.  The Warner Lambert/Parke Davis and the Wyeth Consent Decrees preceded the FDA document. Schering-Plough’s came at the same time Pharmaceutical CGMPs for the 21st Century was issued, and more recent companies have entered into Consent Decrees, the latest being Genzyme. 

Genzyme’s Consent decree comes in parallel with significant cGMP issues at the Johnson & Johnson McNeil facility in Fort Washington, PA.  The issues observed at both Genzyme and McNeil are similar to those found in

Vermont Disclosure of Free Samples - What Will Be the End Result?

written by Alexis Stroud - Manager, Regulatory Compliance at QPharma

On May 27, 2010, Vermont Senate Bill 88, An act relating to health care financing and universal access to health care in Vermont (S.88) became law, without the Governor’s signature. Among other things, S.88 amends Vermont's Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General's Office all free samples of prescribed products provided to health care providers during the preceding calendar year. The bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information.

Who is Required to Report?
Each manufacturer of prescribed products shall disclose to the office of the attorney general all free samples of prescribed products provided to health care providers during the preceding calendar year.

“Sample” is defined as a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device. The term includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price.

What Information is Required to be Reported?
This bill requires manufacturers to identify for each sample the product, recipient, number of units, and dosage.

When is the First Report Due?
The first report is due on April 1, 2012 for the previous year's sampling activity.This section will not apply to samples of prescription drugs required to be reported under Sec. 6004 of the Patient Protection and Affordable Care Act (refer to the white paper “Physician Payment Sunshine Provisions Health Care Reform” for additional information on Sec. 6004), if as of January 1, 2011, the office of the attorney general has determined that the U.S. Department of Health and Human Services will collect and report state- and recipient-specific information regarding manufacturer distribution of free samples of such prescription drugs.

What are the Penalties for Noncompliance?
Failure to Disclose - A civil money penalty of no more than $10,000 per violation. Each unlawful failure to disclose shall constitute a separate violation.

Will the Information Submitted be Available to the Public?
This bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information. Public reporting will not include information that allows for the identification of individual recipients of samples or connects individual recipients with the monetary value of the samples provided (i.e. including the names or license numbers of individual recipients).

Current Controversy over Sample Disclosure
With the passing of this bill, Vermont has become the first state to enact sample disclosure reporting requirements. This bill was passed without Governor Douglas’ signature. He states, “… the drug sample reporting provision adds burdensome new regulations that are unnecessary and could make it difficult for low-income Vermonters to receive needed medications. These sections do not represent meaningful reform; rather they detract from the serious work ahead.” Although S.88 includes these provisions, Governor Douglas decided to allow the bill to become law because it includes a critical expansion of the innovative Vermont Blueprint for Health.

This provision was initiated over concerns that there is a correlation between the distribution of samples and the prescribing patterns of doctors who receive them. A number of senators objected to the sample disclosure requirements. Rutland senator Kevin Mullin argued that the bill would have a chilling effect on the use of free samples in Vermont.


Do you think the disclosure of this information will deter practitioners from accepting or requesting products? Should manufacturers be required to report the distribution of free samples and is there a benefit to making this information available to the public? Please share your opinions here...

Understanding both Electronic and Handwritten Signatures within the Context of Part 11

Written by Robert Finamore - Director, Validation Services, QPharma

21 CFR Part 11; Electronic Records, Electronic Signatures defines the FDA’s requirements for using records and signatures in electronic form to meet the record-keeping requirements of Agency regulations.  In more than ten years dealing with Part 11 compliance, I have often seen confusion over exactly what constitutes an “Electronic Signature.”  The title of the regulation itself uses the term “Electronic Signature,” which is somewhat of a misnomer since the regulation deals with several different types of signatures that are used in electronic form.  The different types of signatures include standard electronic signatures, digital signatures, and handwritten signatures captured electronically.

Electronic Signatures (“e-sigs”) are the types of signatures most people think of when considering Part 11.  Electronic Signatures are defined as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.”  This indicates that some information must be entered electronically and associated to a record for that record to be considered signed.  There are two standard types of e-sigs: Biometric and Non-Biometric signatures.

Biometric Electronic Signatures involve “a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.”  This unique measurement must be captured every time a record is signed and such measurement would need to be securely linked to the signed record.  Examples of biometric signatures included fingerprint scans or iris scans.  This type of signature requires some type of measurement hardware attached to the computerized systems for the signature to be executed so it has not currently seen widespread use in the life science industries.  Biometric Signatures must comply with both the General Signature Requirements and Electronic Signature Requirements as defined in §11.50, §11.70, §11.100, and §11.200(b) of the regulation.

The other type of standard e-sig is the Non-Biometric Signature.  This type of signature requires entry of two or more distinct signature components into the computerized system as the e-sig execution action.  The traditional e-sig requires entry of a User ID and. . .

Breaking News! FDA to Audit Pharma's Electronic Recordkeeping

We sent our valued clients and colleagues this update last week, but for those of you who are not on our mailing list...

The FDA will begin auditing pharmaceutical companies electronic recordkeeping capabilities to evaluate the industry’s compliance with 21 CFR Part 11.



According the article by Ed Silverman of Pharmalot, “…the FDA is about to begin a series of so-called inspectional findings at many drugmakers… The precise timing and number of facilities to be audited - and these are audits, in effect - has yet to be determined, but they will be conducted by the FDA’s Center for Drug Evaluation and Research, or CDER.”


To view QPharma’s webinar on how to stay Part 11 compliant with your training systems, visit our website here. Simply register on the site to take advantage of the Part 11 recording that, when aired live, attracted over 200 attendees from 7 different countries worldwide. It also contains a high-level overview of iCertify 3.0, QPharma's 21 CFR Part 11 Compliant training system for the life science industry.

For the full article, click here: PharmaLot

A Proud Corporate Partner of the Healthcare Businesswomen's Association (HBA)

QPharma would like to congratulate Alexis Stroud, our Manager of Regulatory Affairs, for being recognized by the HBA as a Rising Star in the life sciences industry!

Alexis began her exceptional career at QPharma since its inception, and quickly became a leader in the Regulatory and Compliance space. Her breadth of knowledge and attention to detail is invaluable; Alexis holds an MBA in Pharmaceutical Management and recently became an ASQ Certified Quality Auditor. She passes this experience on to all levels of the organization and unselfishly volunteers support to every project that come through QPharma’s doors, earning her the respect of both valued clients and admiring colleagues. 

If your colleagues were also nominated and recognized for this award, please feel free to share in the comments section below!

Congratulations to all of the Rising Stars and winner of the Women of the Year Award for 2010, GlaxoSmithKline President of North America Pharmaceuticals, Deirdre Connelly, for your prestigious awards!

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