Labcompliance News, July 2011
USP: Current and Future Directions
Anthony J. DeStefano, Ph.D., Vice President, General Chapters, US
Pharmacopeia, gave an interesting presentation with overview on USP
directions. The presentation also outlines the USP organization and
which expert committees exist. In addition Dr. DeStefano explains
the meaning of general chapters with numbers below and above 1000,
how general chapters are developed and the relationship to general
notices and monographs. USP's harmonization efforts has been
demonstrated using the update of general chapter <621> as an
example. As of July 2011 the presentation is available on-line.
FDA Update on Part 11
George Smith who heads up FDA's Part 11 working group gave an update
on FDA's Part 11 activities at the DIA 2011 conference in Chicago.
The presentation included history and current state of Part 11, an
update on the FDA's Part 11 inspection assignments, areas of FDA's
concern and misinterpretation and inspectional observations. Mr.
Smith also talked about possible outcomes of the program and next
steps. One of the key points was that currently there is no
foreseeable end time, so inspectors most likely will look at
computer systems and electronic records over the next months. The
presentation is included in the reference material of the seminar
to prepare yourself for FDA's on-going Part 11 Inspection Program
and is also available to
Usersclub Members. To preview the site,
GMP Annex 11 enforced since July 1
The EU GMP Annex 11 for using computers in GMP environments
has been published in January this year with a grace period until
June 30. This Annex 11 mandatory for all organizations marketing
drugs and other medicinal products to Europe. Together with
the updated EU GMP Chapter 4 on documentation it is the EU
equivalent to FDA's Part 11. It addresses the regulatory needs of
modern IT equipment and when implemented right, also has business
benefits through reduced failure rates. The document is a good
framework for validation and using computer systems and handling
electronic records in different regulated environments. On the other
hand it leaves a lot of room for interpretation that raises lots of
questions. Sign up for the Labcompliance
audio seminar to learn everything about the new release of Annex
11 and EU GMP Chapter 4 and receive 10+ best practice for easy
Response to 483 after 15 business days declined by
Companies receiving a 483 inspectional observation are advised to
respond within 15 business days. A good response can influence
FDA's decision to issue a warning letter or not. Responses sent
later than 15 business days are not considered any more for issuing
warning letters. Details can be found in a warning letter from April
2011. The inspection was finished on August 26, 2010. Written
responses dated September 23 and later have not been considered by
the FDA when writing the warning letter. "We (FDA) acknowledge your
written responses, dated September 23, 2010, October 11, 2010,
October 28, 2010, and December 16, 2010, to the Form FDA 483.
However, because these responses were received more than 15 business
days after the Form FDA 483 was issued; these responses have not
been considered. We plan to evaluate your additional responses to
the Form FDA 483, along with any other written material provided, as
a direct response to this Warning Letter.
The Warning Letter can be downloaded from the
Labcompliance Usersclub. Scroll down to W-253.
Non members can
FDA Introduces a Spectral Library to Detect
Improper Ingredients in Drugs
Globalization of the pharmaceutical supply chain has increased the
challenges to FDA to ensure that drug products and ingredients are
not contaminated, counterfeited, or mislabeled. To help in this
effort, the agency has developed rapid screening methods for
pharmaceutical products and ingredients that can be deployed on
portable instruments by field laboratories and inspectors for the
screening of dietary supplements, pharmaceutical ingredients, and
finished products on site (e.g., at border crossings, import
centers, foreign manufacturing sites. During the past year, FDA's
Division of Pharmaceutical Analysis (DPA) has developed a deeper
understanding of the value and limitations of library-based Raman
and NIR spectral-correlation methods for rapid spectroscopic
screening of pharmaceutical ingredients. DPA would now like to build
an excipient library to be deployed on NIR and Raman portable
instruments and used at points of entry or storage. The full article
has been published by Pharmaceutical Technology (PT).
This article provides details on
how to participate, and some anticipated questions and answers.
As of July 2011 the article is available on the PT website.
Copyright rests with the publisher.
New Article on Quality Risk Management Principles
With Case Studies
Recognizing the need to propagate
and expedite holistic adoption of quality risk management across the
pharmaceutical industry, about a year ago the Product Quality
Research Institute Manufacturing Technology Committee (PQRI–MTC)
commissioned a small working group of industry and FDA
representatives to seek out good case studies of actual
risk-management practices used by large bio/pharmaceutical firms to
share with the industry at large. The working group shared its
experience in an article published by Pharmaceutical Technology.
As of July 2011 the article is available on the PT website.
Copyright rests with the publisher. For other articles from
Pharmaceutical Technology, click here.
Free Document of the Month
As a 'Thank You' for our visitors
Labcompliance offers every month one document for free. This month's
document is the SOP "Handling Security Patches".
To download your free copy, go to the
Network Quality Package website. Scroll down
and click on the corresponding ICON on the left (offer expires on
August 15 , 2011).
Labcompliance offers more than 130 SOPs
that help to comply with FDA and ISO 17025 compliance. For titles
and ordering, click
Audio Seminar Schedule
Understanding the New USP Chapters 232/233 for Metal
With SOPs and Case Studies for Easy Implementation
Recorded, available at any time
Verification of Compendial Procedures according to the Updated
USP Chapter <1226>
Understand the new risk based approach and and get real world
case studies for testing
Recorded, available at any time Recorded,
New or Updated Sites