Editorial: Quality Assurance of Powder-Filled, Hard-Gelatin Capsules

Editor's Note: This is the first in a series of brief quality-assurance notes and reminders on different compounded dosage forms. Many of the testing methods can be done in-house and some may need to be outsourced; this is up to the individual pharmacist. However, a program of quality assurance is the responsibility of compounding pharmacists in all aspects of their practice.

Powder-filled, hard-gelatin capsules can be tested by observation, as well as physical and chemical test procedures. The appropriate tests should be selected, conducted, and documented on the compounding record for the individual compounded preparation.

Quality-control assessment generally used for these capsules include:^1,2

1. Weight-overall average weight
2. Weight-individual weight variation
3. Dissolution of capsule shell
4. Disintegration of capsule content
5. Active-drug potency/assay
6. Physical appearance (color, uniformity, extent of fill, locked)
7. Physical stability (discoloration, changes)

Procedures for these tests are described in the publication of reference 1, which also includes a worksheet which can be used in association with the compounding record.

References
1. Allen LV Jr. Standard operating procedure for quality assessment of powder-filled, hard-gelatin capsules. IJPC 1999; 3(3): 232-233.
2. International Journal of Pharmaceutical Compounding, Inc. [CompoundingToday.com Website.] Available at: www.CompoundingToday.com.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Sen. Grassley Requests FDA to Clarify Employees' Right to Speak Up About Agency Matters
Senator Chuck Grassley has stated that employees of the FDA deserve clarification about their ability to communicate with Congress and the Inspector General following a recent memo that warned employees about releasing information.

"Federal laws protect whistleblowers and allow people who work in the federal bureaucracy to discuss what's happening inside an agency with other officials. Attempts to silence whistleblowers are illegal," Grassley said. The memo may be contrary to the President's call for open and transparent government.

Grassley is a longtime advocate for whistleblower protections for federal employees. He co-authored the Whistleblower Protection Act of 1989, and has co-sponsored legislation to update the law. Grassley also conducts extensive congressional oversight.
http://pharmalive.com/news/index.cfm?articleID=614290&categoryid=9&newsletter=1

The APA Phases Out Industry-Supported Symposia
The American Psychiatric Association (APA) Board of Trustees has voted to phase out industry-supported symposia along with industry-supplied meals at its annual meetings.

With this action, the APA is at the leading edge of a trend throughout medicine to increase transparency and reduce potential financial conflicts of interest.

The APA came to the conclusion that the only way to totally eliminate the risk is to have the symposia supported by the APA alone. There is a perception that by even accepting meals provided by pharmaceutical companies, there may be a subtle influence on doctors' prescribing habits. What was acceptable five years ago isn't necessarily acceptable today according to their leadership; change is necessary, and the APA wants to stay at the forefront of a new and better way of doing things.
http://pharmalive.com/news/index.cfm?articleID=614455&categoryid=9&newsletter=1

University of Pittsburgh Medical Center to Stop Reps' Delivery of Drug Samples
The University of Pittsburgh Medical Center now has a ban on the delivery of samples by drug company representatives to doctors' offices in its 20 hospitals. This does not prohibit distributing samples and vouchers to patients. It ends regular sales and delivery visits by pharmaceutical reps.

The policy is meant to eliminate perceived or actual conflicts of interest between UPMC providers and drug companies. UPMC banned gifts and meals to hospital personnel by healthcare companies more than a year ago.
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1896261&contentType=sentryarticle&channelID=33

Ex-Pfizer Manager Found Guilty of Obstruction
A New York man was convicted on March 16, 2009, in federal court of obstruction of justice. Evidence presented during the trial proved that in the summer of 2004, a Pfizer District Sales Manager caused a sales representative under his direction to alter documents and backdate the alterations on his computer to delete the evidence of the promotion of a drug for uses and dosages for which it was not indicated or approved for promotion by the United States Food and Drug Administration. The evidence demonstrated that the former Pfizer employee instructed his sales representative on how to change the clock and date setting on the computer, and then alter and re-save the documents in order to make the sanitized documents appear to have been last modified at an earlier time.

The individual faces up to 20 years imprisonment, to be followed by 3 years of supervised release, and a $250,000 fine. Pfizer Inc disclosed this conduct to the United States and fully cooperated in the investigation and prosecution of the case.
http://pharmalive.com/news/index.cfm?articleID=613088&categoryid=9&newsletter=1

�that according to Bloomberg that former Senator "Daschel says health-care reform will not be pain free. Seniors should be more accepting of the conditions that come with age instead of treating them." It should be noted that Daschel has his own government retirement plan that is unique to Congress and will not be subject to the same limitations as we are.

Garbage In, Garbage Out
Listen, evaluate, and confirm what you hear. If one acts on incorrect data, it may have undesirable results.