Labcompliance News, August 2008
FDA Releases Draft Guidance for Residual
Solvent Analysis (USP <467>)
The Food and Drug Administration (FDA) has released a new draft
guidance for industry entitled ``Control of Residual Solvents in
Drug Products Marketed in the United States.'' The guidance has
recommendations on how to comply with the new USP chapter <467>
RESIDUAL SOLVENTS that has been released on July 1, 2008.
For example, the draft guidance also defines the conditions
under which analytical procedures other than those described in USP
<467> will be accepted. The new guideline can be downloaded
from the
FDA
Website. To learn everything about
residual solvent analysis according to the new USP chapter and FDA
guidance and to receive 10+ best practice documents for easy
implementation,
click here.
FDA Released New Guidance Regulatory Submissions in
Electronic Format
The guidance with the title: "Providing Regulatory
Submissions in Electronic Format – Postmarketing Individual Case
Safety Reports" is one in a series of guidance documents intended to
assist applicants making regulatory submissions in electronic format
to FDA's CDER and CBER. This guidance discusses general information
related Drug products marketed for human use with approved new drug
applications (NDAs) and abbreviated new drug applications (ANDAs),
Prescription drug products marketed for human use without an
approved NDA or ANDA, Biological products, including therapeutic
vaccines,marketed for human use with approved biologic license
applications (BLAs) and submission tracking numbers (STNs) Human
cells, tissues, and cellular and tissue-based products (HCT/Ps)
regulated under section 361 of the Public Health Service Act,
Quality and Validation Issues Draw FDA
Warning Letter
A device manufacturer received a warning letter for several
deviations related to quality management, other quality system and
validations. The company did not have implemented with
executive responsibility to ensure the quality policy has been fully
implemented and maintained. Also there was no quality plan for over
three years. The FDA also found that the company did not establish
and maintain purchasing control procedures". Deviations related to
validation have been: "Failure to validate your water purification
systems" and "Failure to validate your software used for fluid
delivery and heat disinfection in your water purification systems".
The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 205).
New Version 3.0 of the Computer System
Validation Package Released
On August 15 Labcompliance has released a new major revision of
the popular computer system validation package. The new version
includes 6 new SOPs, 2 new audio seminars, 7 new validation examples.
In addition most other key documents have been updated to reflect
most recent recommendations from FDA and international agencies and
from industry task forces.. For additional information and ordering,
click here.
New FDA Rule and Guidance for Early Stage
Clinical Drug Development
On July 18 The U.S. Food and Drug Administration issued a final
regulation that makes early phase 1 clinical drug development safe
and efficient by enabling a phased approach to complying with
current good manufacturing practice (CGMP) statutes and FDA
investigational requirements. To facilitate this new approach, the
regulation exempts most phase 1 investigational drugs from the
requirements in 21 CFR part 211. at the same time the FDA released a
companion guidance that describes an approach manufacturers can use
to implement manufacturing controls that are appropriate for the
phase 1 clinical trial stage of development. The approach described
in this guidance reflects the fact that some manufacturing controls
and the extent of manufacturing controls needed to achieve
appropriate product quality differ among the various phases of
clinical trials.
New USP Chapter <467> Residual Solvents
Effective Since July 1, 2008
On July 1, 2008 the new USP-NF General Chapter <467> Residual
Solvents finally come into effect. Main change to the previous
official version is the adoption of Q3C in the general chapter of
the USP while eliminating the Organic Volatile Impurities (OVI)
tests from the individual monographs.
Using the risk based approach more than 60 solvents have been broken
down in three classes with different toxicity and therefore with
different requirements for maximum limits. To learn everything
about
the changes of <467> and to receive 10+ best practice documents for
easy implementation,
click here
FDA Warning Letter Issued for not Validating
Software
A device manufacturer was cited for not validating device
software design. The letter reads; "Failure to establish and
maintain adequate procedures for validating the device software
design to conform to the intended uses. For example: The validation
results do not meet the pre-determined acceptance criteria, and
there was no documentation why the results were acceptable. The
validation reports do not contain an evaluation of the validation
data and activities. Nor does it contain validation analyses and
conclusion". The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 204). Learn all about FDA
compliant software and computer system validation and get master
plans, SOPs and other documents for easy implementation with the
Labcompliance
Computer System Validation Package.
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:
Subcontracting of Testing and Calibration.. To download your free
copy, go to the
ISO 17025, scroll down and click on the corresponding ICON on
the left (offer expires on September 15). Labcompliance offers more
than 100 SOPs. For titles and ordering, click
here.
New Audio Seminars - Updated Schedule
-
Effective Training Practices for FDA Compliance
What to train - How much to Train - How to Document
Effectiveness
Sept 4, 2008
-
Test Scripts and Protocols for Equipment and Computer Validation
(205)
With SOPs , examples scripts and protocols for FDA and EMEA
compliance
Sep 18, 2008
-
Residual Solvent Analysis According to USP <467> (206)
Understanding and implementing the revised chapter
Oct 16, 2008
-
Validation of Existing/Legacy Systems (207)
Regulatory requirements and tools for implementation
Oct 23, 2008
-
Bioanalytical Method Validation (208)
Conduct and Document for Efficiency and FDA and EMEA compliance
Nov 06, 2008
-
Raw Data in FDA Regulated Environments (209)
FDA/EU compliant recording, maintenance and archiving
Nov 13, 2008
IVT Conferences
-
IVT's 5th Annual
Method Validation
Conference
October 14-16, 2008
Hyatt Fisherman's Wharf in San Francisco, CA.
-
IVT
Computer System
Validation
October 14-16, 2008
-
IVT
PharmSep Symposium
September 9-11, 2008
Pennsylvania Convention Center, Philadelphia, PA
New or Updated Sites