Labcompliance News, February 2008
New FDA Guidance Regarding the Labeling of
Non-Prescription Human Drugs
The Food and Drug Administration (FDA) announced
the release of a draft guidance entitled ``Questions and Answers
Regarding the Labeling of Nonprescription Human Drug Products
Marketed Without an Approved Application as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act.'' The
guidance is intended to assist industry in complying with the
labeling requirements for nonprescription (over-the-counter (OTC))
human drugs marketed without an approved application established by
the Dietary Supplement and Nonprescription Drug Consumer Protection
Act. The
announcement and the
guidance
is available on FDA's website.
New ISO 17025 Accreditation Package
On February 19, 2008, Labcompliance launched the new ISO 17025
Accreditation Package. The package is a complete solution for
laboratories that want to build a modern quality system, for
example, according to ISO 17025.. The Package comes with:
- tools for training, such as an audio seminar
- tools for developing strategies and policies through an
example quality plan
- tools for implementation and maintenance through SOPs, forms
and checklists
The package is ideal for testing and calibration laboratories
that plan to get ISO 17025 accreditation. For more information and
ordering,
click here
New FDA Guidances in 2008
FDA CDER published a list of guidances the agency is planning to develop
during
calendar year 2008. Quite interesting will be work on "Standards Recognition" in
the Chemistry section. For the complete list,
click here
ILAC Published a Guideline for Providers of
Proficiency Testing Schemes
Participating in proficiency testing is recommended by ISO 17025
as one way to assure the quality of test and calibration
results. Such schemes are only useful if they are
performed competently through competent providers. This is what the
new ILAC guidelines has been developed for. This document is for
providers of proficiency testing schemes who wish to demonstrate
their competence by formal compliance with a set of
internationally-acceptable requirements for the planning and
implementation of proficiency testing schemes. The guidelines can be
downloaded from the
ILAC
website. The Guidelines are based on the technical elements of
ISO Guide 43-1:1997 and on the relevant elements of ISO/IEC
17025:2005. To learn everything about ISO 17025 accreditation,
click here
New FDA Guidance Regarding the Labeling of
Dietary Supplements
The Food and Drug Administration (FDA) announced in the Federal
Register of January 2. 2008, the availability of a draft guidance
entitled ``Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.'' This draft guidance
is intended to assist the dietary supplement industry in complying
with the labeling requirements prescribed for dietary supplement
manufacturers, packers, and distributors by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act (the DSNDCPA).
Separate guidance, issued by the Center for Drug Evaluation and
Research on labeling requirements for nonprescription
(over-the-counter) human drugs marketed without an approved
application, is announced in the Federal Register listed below. The
announcement and the
guidance is available on FDA's website.
Lack of Method Transfer or Revalidation
Protocol Cited in an FDA Warning Letter
The FDA expects analytical methods that are transferred between
laboratories to follow a pre-approved transfer protocol. This became
obvious in an FDA warning letter. The warning letter stated:
"Methods that were validated at one facility and transferred to xxx
site are being used without method transfer or revalidation
protocol". The FDA also noted that there was no establish
scientifically sound and appropriate specifications, standards,
sampling plans, and test procedure designed to assure products
conform to appropriate standards of identity, strength, quality, and
purity. FDA's expectations for method validation, revalidation and
method transfer and various options for compliance will be discussed
in a new Labcompliance
audio seminar that has been recorded and is available with all
reference material. The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 187).
OECD Advice for Archiving
The OECD Working Group on Good Laboratory Practice has developed
the advisory document on "Establishment and Control of Archives that
Operate in Compliance with the Principles of GLP". The guidance has
sections on responsibilities, facilities, security, procedures,
archiving of electronic records, quality assurance and contract
archive facilities. The document has been published as OECD
Consensus Document #15. The document is available from the
OECD website.
New Audio Seminars - Schedule for H1/2008
-
Validation of Analytical Methods and Procedures (190)
Conduct and Document for Efficiency and FDA, USP/EP and ISO
17025 Compliance
February 28, 2008
-
Understanding USP Documents and Reference Standards (191)
General Chapters, General Notices, Monographs, Forum, Reference
Standards
March 13, 2008
-
Understanding the New USP <1058> for Analytical Instrument
Qualification
With SOPs and Case Studies for Easy Implementation
March 27, 2008
-
Learning from Recent FDA Warning Letters Related to Computer
Validation
and Part 11
With Clear Recommendations for Corrective and Preventive Actions
Thursday, April 3, 2008
-
Selection and Use of (Certified) Reference Material
Strategies for FDA/ISO 17025 Compliance and Tools for
Implementation
Tuesday, April 15, 2008
New or Updated Sites