Labcompliance News, July 2009
Pharmaceutical manufacturers aiming to thwart
drug product counterfeiting have been investigating technologies that may make
drug products more difficult to duplicate. One approach that pharmaceutical
manufacturers appear to be considering involves adding a trace amount of an
inactive ingredient(s) to an existing
section3
of the dosage form. A unique physical-chemical characteristic of that
ingredient makes it possible to detect and authenticate legitimate dosage forms
and identify counterfeits. Examples of substances that may be incorporated
into solid oral dosage forms (SODFs) as physical-chemical identifiers (PCIDs)
include inks, pigments, flavors, and molecular taggants. The new FDA draft
guidance prrovides recommendations design considerations for incorporating PCIDS
into SODFs, supporting documentation to be submitted in NDAs and ANDAs to
address the proposed incorporation of PCIDs in SODFs, supporting documentation
to be submitted in postapproval submissions to report or request approval to
incorporate PCIDs into SODFs, and procedures for reporting or requesting
approval to incorporate PCIDs into SODFs as a postapproval change. The guiadnce
can be downloaded from the
FDA website.
U.S. Marshals Seize Drug Products to Prevent Repeated
Drug Quality Problems
On June 25, 2009, U.S. Marshals, at the
request of the Food and Drug Administration, seized drug products
manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at
the company’s Michigan facilities in Detroit, Farmington Hills, and
Wixom. The seizure also includes ingredients held at these same
facilities.
“The FDA is committed to taking enforcement action against firms
that do not manufacture drugs in accordance with our good
manufacturing practice requirements,” said Janet Woodcock, M.D.,
director of the CDER, FDA. Through this seizure, the FDA seeks to
immediately stop the firm from further distributing drugs until
there is assurance that the firm complies with good manufacturing
requirements.
[Read More]
South East Asia Moving to Harmonized GMP
Inspections
On April 10, 2009, all 10 member countries of
the Association of Southeast Asian Nations (ASEAN) have signed a
Mutual Recognition Agreement (MRA) to harmonize GMP inspections.
Member states are obliged to establish inspection services for
conducting GMP audits and issuing Reports/Certificates. Also, each
member state is obliged to accept and recognize GMP
certificates/Reports issued by listed inspection services of another
member state. GMP certificates are issued in accordance to the PIC/S
GMP Inspection Framework. This also means, drug companies marketing
products in all ASEAN member countries should implement PIC/S GMP
guidelines. While Singapore and Malaysia are already PIC/S members,
PIC/S GMP compliance is not easy for some countries For example, it
is estimated that currently only 5% of the drug industry in the
Philippines complies with international GMP regulations. To learn
more about the history, status, process and steps for implementation
of the MRA and to download a presentation given by Sia Chong Hock,
chairman of the ASEAN MRA taskforce,
click here.
FDA Requests Meeting with Senior Management to
Discuss Inspection Outcome
After an inspection of a manufacturer of
biological vaccine products, bulk drug substances, and drug
components the FDA requested a follow-up meeting with senior
management The letter states: "To facilitate your remediation
efforts we request a meeting with you and other senior management to
further discuss the issues cited in this letter and your proposed
responses to address them". Cited deviations included: Computer
output not checked for accuracy, failure investigations not extended
to other batches, expiration date of reference material extended
without supporting data, procedures to prevent facility
contamination incomplete, written procedures for equipment
maintenance not followed. The warning letter can be downloaded from
the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 217).
To prepare your organization for FDA inspections, and to avoid FDA
warning letters, attend the upcoming
Audio seminar: Successful FDA Inspections - preparation,
conduct, follow-up.
FDA Requests Certification by an Outside
Consultant
During an inspection of a device manufacturer FDA
inspectors found several GMP deviations. Examples included: "No or
inadequate procedures for design control, no procedures to ensure
quality of purchased products and services, no procedures for
document control". The letter stated towards the end; "We
are requesting you submit to this office, on the schedule below,
certification by an outside expert consultant to state he/she has
conducted an audit of your establishment's manufacturing and quality
assurance systems relative to the requirements of the device Quality
System regulation The warning letter can be downloaded from
the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 218).
To prepare your organization for FDA inspections, and to avoid FDA
warning letters, attend the upcoming
Audio seminar: Successful FDA Inspections - preparation,
conduct, follow-up.
FDA Publishes Article on Drug CGMPs and How
they Contribute to Drug Quality
The recently published article discusses the
role and importance of cGMP in drug manufacturing, as well as
describes what actions FDA takes when a company is not in compliance
with cGMP. The article is written in a Q&A format. One interesting
question was: "If a manufacturer is not following cGMPs, are drug
products safe for use? To read the artcle,
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: Laboratory Failure Investigations . To download
your free copy, go to the
Laboratory Compliance Package website. Scroll down and
click on the corresponding ICON on the left (offer expires on July
31, 2009). Labcompliance offers more than 100 SOPs that help to
comply with FDA and ISO 17025 compliance. For titles and ordering,
click
here.
New Audio Seminar Schedule
Understanding and Implementing ISO 17025
Requirements, Strategies and Tool Kits for Laboratory
Accreditation
July 23, 2009
Successful FDA Inspections
Preparation - Conduct - Follow Up
July 30, 2009
New or Updated Sites