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The FDA released a new new draft guidance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 The draft guidance provides recommendations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The draft guidance can be downloaded from the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