An overview of GMP Trends Newsletter service

2. What it means to be CGMP
CGMP mandated by the U.S. Food Drug and Cosmetic Act
A drug…shall be deemed to be adulterated…if the methods used in, or
the facilities or controls used for, its manufacture, processing, packing, or
holding do not conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that such drug
meets the requirements of this Act as to safety and has the identity and
strength, and meets the quality and purity characteristics, which it
purports or is represented to possess. (Section 501(a)(2)(B) of the
FD&C Act)

3. But How do you know what
is “current” GMP

4. Our Mission
GMP Trends® provides the pharmaceutical and medical device industries with
timely, unbiased information related to recent FDA inspections trends. This
critical data is used by business leaders and quality assurance professionals to
ensure compliance with current Good Manufacturing Practices.

5. Who We Are
GMP Trends® was founded because, as quality professionals, we recognized
the need for an unbiased editing of all relevant FDA 483's. Over our 30 years
of providing this information, we have seen our readership grow to encompass
thousands of subscribers in over twenty countries, all working toward a
common goal of improving quality systems, thereby preventing GMP issues
before they occur. Our Editors and Advisory Team are dedicated to bringing
you the information you need in a timely fashion, twice monthly, so that you
can remain in compliance with current Good Manufacturing Practices.

6. Inspections
• Every year, FDA inspects thousands of
companies throughout the world.
• We use the Freedom on Information Act
(“FOIA”) to periodically request the updated
inspection lists.
• Once received, we sort the information into
the different regions and then send additional
FOIA requests to each local FDA office for
redacted copies of the company’s FDA-483

7. Review of 483s
• We are constantly following up with local FDA
offices to receive the updated inspection
reports (FDA-483’s)
• As we receive each group of FDA-483’s, we
review the inspection observations and
categorize them in a database.

8. Creating the Newsletter
• Observations are sorted in the database and
then are chosen for an issue
• Each newsletter is laid out and edited for
content
• Once editing and proofing are completed, the
final format is sent to the printer

9. Distribution of the Newsletter
• Once the newsletter is printed, one copy is
uploaded to the website for on-line viewing
• The remaining newsletters are mailed to each
of our customers that request a print version
• On the 1st and 15th of each month, on-line
subscribers receive an email informing them
that the newsletter is available for viewing.

10. Subscribe Today
http://www.gmptrends.com/subscribe