GMP Trends helps you get in compliance and stay in compliance with FDA regulations governing the pharmaceutical and medical device industries.

2. • If you are a manufacturer of
pharmaceutical products or
medical devices, you are subject
to oversight and inspection by
the US FDA.
• They can inspect you at any time
for compliance with current
Good Manufacturing Practices
FDA Inspections

3. What it means to be GMP
The specific language in the Food Drug and Cosmetic Act states:
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)

4. Good Manufacturing Practices are
constantly evolving and FDA expects
you to keep up with what
is “current” GMP

5. But how can you know what
is “current” GMP

6. Maybe ..
You talk to consultants..
You read trade publications..
You participate in online forums..
You talk to colleagues ..
It’s a maze of information
heavily biased by personal
opinion and special interests

7. 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.

8. How do we do it?
• We use the Freedom of Information Act
(“FOIA”) to constantly request the
updated inspection details from FDA
headquarters on the thousands of
inspection conducted every year.
• We review the details of EVERY inspection
• We sort the lists based on the inspection
details.
• Then we obtain the detailed information
from the different regions – again using
FOIA.

9. Review of Information
• 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.

10. Distribution of the Information
• We make this data available to you via a
searchable online database.
• We also make the content available in newsletter
form that is published twice a month - On the 1st
and 15th of each month.
• On-line subscribers receive an email informing
them that the newsletter is available for viewing.
• In print customers receive the newsletter in the
mail each month.

11. http://www.gmptrends.com/subscribe