Labcompliance News, September 2008
FDA Publishes Amendments to the cGMPs for Finished Drugs
On Sept 8, 2008, the FDA published changes to FDA's drug GMP regulations
(Part 210/211) as final rule. This finalizes the first phase of FDA incremental
approach to modifying the cGMPs for finished drugs. The first version has
already been published in Dec 2008 as final rule but was withdrawn in April as a
result of a significant adverse comments from industry. The amended
rule will be effective on Dec 8, 2008. Major updates are in the area of aseptic
processing, asbestos filters and verification of certain operations a second
individual. Current cGMPs require that certain operations are performed and
signed by one person and verified and signed by a second individual. The amended
rule requires only one signature if the operation is performed by a validated
automated instrument. Examples are equipment cleaning and maintenance and batch
production and control records.
FDA Launches New Health Professionals
Website
FDA recently launched a new
Health
Professionals web page as part of a larger effort by the agency
to increase interactions and communications with health professional
organizations. The webpage provides useful, timely, and accessible
information to the nation's physicians, nurses, pharmacists, and
other members of the health professional team.
Stability and Impurity testing cited in FDA
Warning Letter
A drug manufactured has been cited for inadequate stability and
impurity testing. The letter reads: Failure to establish a stability
testing program which includes reliable, meaningful, and specific
test methods'. In addition, although your firm conducts impurity
testing for xxxx tablets, xxxx softgels, xxxx caplets and xxxx
tablets, it does not have written procedures for impurity testing".
Furthermore the FDA found other deviations from cGMP regulations
especially in the area of electronic records integrity. They include:
no failure investigation, no procedures to ensure authenticity,
integrity, and security of electronic records, system administrator
privileges assigned to chemists, chromatograms manipulated, and
methods used by outside contractor not validated. The warning letter
can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 203).
FDA Published ICH Draft Guidance for Non-clinical
Safety Studies
The guidance entitled "Nonclinical Safety Studies for the Conduct of
Human Clinical Trials and Marketing authorization for
Pharmaceuticals" has been preleased at Step 2 of the ICH Process, It
has been transmitted by the ICH Steering Committee to the regulatory
authorities of the three ICH regions (the European Union, Japan and
the USA) for internal and external consultation. The purpose of the
document is to recommend international standards for, and promote
harmonization of, the nonclinical safety studies recommended to
support human clinical trials of a given scope and duration and
marketing authorization. Harmonization of the guidance for
nonclinical safety studies will help to define the current
recommendations and reduce the likelihood that substantial
differences will exist between regions. This guidance should
facilitate the timely conduct of clinical trials, reduce the use of
animals in accordance with the 3R (reduce/refine/replace) principles
and reduce the use of other drug development resources. This should
promote safe and ethical development and availability of new
pharmaceuticals.
Device Manufacturer Lacked Test Scripts for
Training Data Bases
A device manufacturer received a warning letter for several
deviations related to computer validation and other quality issues.
For example: "Software validation used to document employee training
was deficient in that the test scripts were not available to show
the execution of the software validation protocol. It appears that
at least five (5) tests specified in the. approved protocol were not
performed". Other deviations in the letter are: no procedures for
failure investigations, no procedures to report and follow quality
problems, corrective actions identified but not implemented,
corrective action, no acceptance procedures for in-process products,
no procedures to verify conformance of purchased products,
inadequate complaint investigation, failure to identify training
needs, training requirements incomplete, no procedures for internal
audits, no sampling procedures, sampling plans not reviewed, wrong
procedure in document. The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts (scroll down to 206). 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.
GMP Annex 7 "Manufacture of Herbal Medicinal
Products" Revised
This revision has been made to specify application of GMP provisions
for active substances used as starting materials (Part II) for the
manufacture of herbal medicinal products. Additional changes are in
particular related to the new Directive 2004/24/EC on traditional
herbal medicinal products. The document applies to all herbal
starting materials: medicinal plants, herbal substances or herbal
preparations. The new Annex has been published on the
EC Website and will come into operation on 01 September 2009.
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:
Retention and Archiving of Electronic Records. To download your free
copy, go to the
Computer System Validation Tutorial, scroll down and click on
the corresponding ICON on the left (offer expires on October 1).
Labcompliance offers more than 100 SOPs. For titles and ordering,
click
here.
2 Day Interactive Workshop by Dr. Ludwig Huber
-
ECHO Consulting Group
Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical
and Device Industry
Jan. 20/21, 2009 San Juan, PR, USA
Learning through examples: 50% of the time will be dedicated to
case studies
New Audio Seminars - Updated Schedule
-
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
Conferences
http://www.echo-cg.com/calendar.html
-
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
New or Updated Sites