Labcompliance News, April 2010
FDA Inspections for 21 CFR 111 (Dietary
Supplements) will become Common
The final version of FDA's regulation on
dietary supplements has been released in 2007 and FDA started
inspecting larger manufacturers in 2009. From June 25, 2010, all
companies manufacturing dietary supplements have to comply with GMPs
and FDA inspections will become increasingly common also for small
companies with less than 20 employees. All companies are advised to
train employees on GMPs and to prepare the necessary documentation
for inspections. Labcompliance will conduct an audio seminar
"Implementing FDA's 21 CFR 111 for Dietary Supplements". The speaker
gives an introduction to the rule and shares information from past
FDA inspections. Attendees will get 10+ best practice documents such
as SOPs, checklists and case studies for easy implementation. For
more information and registration,
click here.
Pharmacopoeial Discussion Group (PDG)
Recommendations for Dissolution Testing
FDA has published an industry guidance based on Annex
7 of Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in
the ICH Regions. The guide lists conditions when Pharmacopeial Dissolution
Test for Solid Dosage Forms, JP 6.10 Dissolution Test, and USP <711>
Dissolution, can be used as interchangeable in the ICH regions. For example,
the text states that an appropriately rigorous mechanical calibration method
such as ASTM E2503-07 and a recently published
FDA Recommendation, when properly executed, should satisfy the current
good manufacturing practice (CGMP) requirement for dissolution apparatus
calibration under 21 CFR 211.160 (b)(4)). The guide can be downloaded from
the
FDA website.
WHO Publishes Guideline for the Production
and Control of Starting Materials
This guideline is intended to assist
applicants or MA holders in assessing the required level of quality
of “specified starting materials” that will be used for the
manufacture of an API. WHO takes an interesting approach which is to
balance costs vs. level of GMP compliance. Quality control for
starting materials should include tests for impurities, such as
isomers, residual solvents, and others impurities. Quality standards
such as GMP principles and recognized pharmacopoeia monographs for
specified starting materials may only be applied if they provide
significant public health benefits. The draft is currently released
to only a specified audience for comment. Together with a more
detailed summary it is available through the
Rx-360 website, the international pharmaceutical supply-chain
consortium,
51-Page FDA Inspection Report Related to
Dietary Supplements
FDA has started inspecting manufacturers of
dietary supplements for compliance with 21 CFR 111. It is quite its
interesting to see which departments will be inspected and what
aspects inspectors might focus. A good source of information are FDA
Establishment Inspection Reports (EIR), especially when they are
detailed. One such EIR has 51 pages. The inspection was performed as
a High Priority Inspection. The report is a detailed protocol on who
had been interviewed, which departments have been inspected and what
the inspection focus was. One of the focus was on how OOS. failure
investigations and corrective actions are handled. The report ended
with a listing of six inspectional observations and one voluntary
correction. The EIR with six 483 observations can be downloaded from
the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-232. Learn all about 21 CFR Part 111 requirements and how to
avoid 483's in the Labcompliance
audio seminar.
How Much Validation is Enough?
This question has ever come up since
validation and testing of equipment and processes has been requested
by the FDA and other agencies. The real issue is that answers are
different from different people with different motivations. For
example, QA managers tend to ask for more to protect themselves not
only 100% but 150%. On the other hand operations manager want to
keep the extend of validation to a minimum because they have to pay
the bill. FDA has generic answers, such as "the nature and extend of
validation depends on the risk a process or system has on
(medicinal) product and patient safety". There is no more specific
advice from the FDA., but inspectors will come and tell you after
the inspection. To escape from this dilemma companies hire external
consultants, but these also may have their motivation which is to
secure follow up business and kindly offer validation services if
the company does not have enough resources. The real good answer
only can come from an organization wide structured approach
that documents the principles and rational and defines validation
activities for different scenarios. Such an approach has been
presented by Dr. Ludwig Huber as plenary lecture at the recent IVT
European Validation Week in Dublin Ireland. This important
topic will also be delivered as an Labcompliance
audio seminar. Attendees will receive 10+ best practices guides
for cost-effective implementation.
FDA Focus on Integrity, Security and
Authenticity of Electronic Records
While FDA was quiet about computer systems between
2002 and 2006. This has changed significantly. Computer systems and
electronic records did become an inspection focus for pharmaceutical, API
and device industry. Deviations have been cited related to all key Part 11
requirements such as limited and authorized access, electronic audit trail,
back-up and archiving of raw-data, system security and discharge of
e-records after print-out. To see recent examples,
click here. To prepare your organization for FDA inspections, and
to avoid FDA warning letters related to electronic records, attend the
upcoming
Audio
seminar: Electronic Raw Data in Regulated Environments. For more info
and ordering,
click
here.
Video on Software Regulation with John Murray
on FDA's Website
The FDA has posted a video presentation with
an introduction to software regulation. The presenter is John
Murray, one of FDA's expert on validating and using computers in FDA
CDRH regulated environments. According to John Murray the the
presentation is not a complete thesis on medical device
software but only serves as an introduction, there is an
expectation that more software related presentations will be
developed in the future.
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: Internal Audit - Preparation, Conduct,
Follow-up. To download your free copy, go to the
FDA Inspection Package website. Scroll down and click on
the corresponding ICON on the left (offer expires on May 10, 2010).
Labcompliance offers more than 120 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
Audio Seminar Schedule
New or Updated Sites