Labcompliance News, May 2009
Review of IVT's 10th Computer System Validation
(CSV) Conference
The 10th annual CSV conference was held in the
Arlington Sheraton Hotel. Attendees did get an update on CSV
requirements and recommendations for cost effective implementation
of CSV and other Part 11 controls. FDA's software and computer
system compliance expert and Part 11 task force member John Murray
gave a keynote presentation on FDA's findings when reviewing CSV
documents. John Murray also answered questions about the status
FDA's 21 CFR Part 11. Most valuable for practical
implementation have been 28 workshops and Interactive discussion
sessions. The conference has been chaired Labcompliance editor Dr.
Ludwig Huber. He will make key learnings and recommendations from
the conference available in an upcoming
audio seminar. For more information about the conference,
click here.
New FDA Guidance on the Submission of Bioequivalence Data.
The FDA released a new new draft guidance which is intended to
assist abbreviated new drug application (ANDA) applicants in
complying with the new requirements in the final rule on the
submission of bioequivalence data published in the Federal Register
in January 2009. The final rule requires ANDA applicants to submit
data from all bioequivalence studies (BE studies) the applicant
conducts on a drug product formulation submitted for approval,
including both studies that demonstrate and studies that fail to
demonstrate that a generic product meets the current bioequivalence
criteria. The draft guidance provides recommendations to applicants
planning to include BE studies for submission in ANDAs, and is
applicable to BE studies conducted during both preapproval and
postapproval periods.
The draft guidance can be downloaded from the
FDA website.
Is it a Cosmetic or a Drug. FDA. or Both? FDA
Provides Answers.
The legal difference between a cosmetic and a
drug is determined by a product's intended use. Different laws and
regulations apply to each type of product. Firms sometimes violate
the law by marketing a cosmetic with a drug claim, without adhering
to requirements for drugs. Sometimes its difficult to decide if a
product is a cosmetic or drug. A New
FDA website
provides information on the legal difference between a cosmetic and
a drug product.
ICH Working Group Answers Questions about Q8/Q9/Q10
Obviously there are many questions about
implementation of ICH guidelines Q8/Q9/Q9. In response to this ICH
published a document with most frequently asked questions and
answers on its
website. Questions are related to design space, release testing,
implementation of pharmaceutical quality systems, software solutions
for implementation, impact on GMP inspections and knowledge
management.
New Version 2.0 of the
ISO 17025 Accreditation Package Released
On May 15 Labcompliance has released a new
major revision of the popular ISO 17025 Accreditation package. The
new version includes 8 new SOPs, an updated quality manual, 5
new checklists and 3 new forms. In addition most other key documents
have been updated to reflect most recent recommendations from
official accreditation committees and laboratory quality system
experts. For additional information and ordering,
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: Measurement Uncertainty in Chemical Testing. To download your free copy, go to
the
ISO 17025 Accreditation Package website.
Scroll down and click on the corresponding ICON on the left (offer
expires on June 12, 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
-
Latest Updates for Computer Validation and
Part 11 Compliance
Learn from FDA and Industry Practioners and get Tools for
Implementation
June 18, 2009
-
Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
June 25, 2009
-
Managing Out of Trend Results in Pharmaceutical
Manufacturing and Quality Control
Comply with the FDA and international guidances
July 9, 2009
New or Updated Sites