Labcompliance News, August 2011
China's SFDA Going for International GMPs
Since the China State Food and Drug Administration has published new
GMPs last year the agency made
the agency has been making progress to improve the
quality of s as well to improve the quality of its pharmaceutical
manufacturing industry. The new standard is based on the well
recognized GMPs of the World health Organization. The new GMPs have
been effective since March 1 this year. New facilities have to
comply right now, existing facilities have a grace period unitil
2010. Read more about history and requirements..
"Excel Spreadsheet not protected against unauthorized Use" cited in
FDA 483
For example, the 483 reads: "Impurity calculations are made via
unvalidated and unprotected Excel spreadsheet programs which are not
managed and controlled to insure unauthorized changes to equations
and/or calculations do not occur. Furthermore the 483 stated: "There
is no documentation of what the Quality Unit reviewed to assure the
correct equation was used and that the correct values were
transcribed onto Finished Product Specification Sheets".
The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-254.
Attend the Labcompliance
audio seminar "Ensuring Integrity and Security of laboratory
data" to learn everything about data security related FDA
inspections and findings and how to avoid inspectional
observations..
WHO Publishes Guidance on Technology Transfer
As part of its Technical Report Series, No. 961 the World Health
Organization (WHO) has published "Guidelines on transfer of
technology in pharmaceutical manufacturing". According to the
guidance "Technology transfer can be considered successful if there
is documented evidence that the Receiving Unit (RU) can routinely
reproduce the transferred product, process or method against a
predefined set of specifications as agreed with the Sending Unit
(SU)". Several guidance chapters give recommendations for the
transfer in production, e.g., processing, packaging and cleaning and
for quality control, e.g., analytical method transfer. The document
can be downloaded from the
WHO website. For more details on analytical method
transfer check the Labcompliance
audio seminar and receive tool kits for easy implementation.
New free Tutorial on Risk Management
Labcompliance has published a new free
Tutorial with the title: Risk Management in the
(Bio)Pharmaceutical and Device Industry. After an overview on
literature and regulations the tutorials explains various
approaches, tools and methodologies for risk assessment and
management. At the end readers are guided through the entire process
step by step.
The FDA has notified pharmaceutical companies that bioanalytical
studies conducted by a Contract Research Organization between April
2005 and June 2010 in support of marketing applications may need to
be repeated or confirmed. The CRO performs bioequivalence and
pharmacokinetic testing for a number of pharmaceutical companies.
The FDA also announced to send letters to drug sponsors with pending
applications, requesting that they either repeat the bioequivalence
testing done by the CRO or retest drug samples using a different
test laboratory or contractor. The reason is concerns relating to
integrity of data. FDA has been taking this action as a result of
two inspections of the CRO's bioanalytical facility conducted in
2010, as well as the company’s own investigation and third party
audit. The inspections and audit identified significant
instances of misconduct and violations of federal regulations,
including falsification of documents and manipulation of samples. To
read the full FDA press release,
click
here. Since quite some time FDA's inspection focus has been on
integrity of laboratory data with disastrous consequences for some
companies. To learn everything about FDA's laboratory inspection
practices and to ensure integrity ob laboratory data, attend the new
audio seminar: Ensuring integrity and security of laboratory
data.
FDA Commissioner Dr. Hamburg Talked about
Sharing Global Inspection Data
Dr. Margaret Hamburg, US FDA Commissioner, delivered a key note
address at PIC/S' 40th Anniversary Symposium in Geneva (Switzerland)
on May 31, 2011. Dr. Hamburg talked about benefits of FDA's public
database COMSTAT which contains FDA inspection results, She
encouraged all represented countries to take advantage of this
information because they may learn from FDA databases and decide not
to duplicate FDA'S inspectional efforts. Dr Hamburg also suggested
to work together in global coalitions of regulators in all of FDA
areas including GMPs for human and animal drugs. According to Dr.
Hamburg, the FDA also believes that global data-information systems
and networks are imperative, so that FDA can proactively share data
with partners. This would begin with inspectional results or GMP
certificates and hopefully extend to include inspection reports and
inspection schedules. To download the presentation script,
click
here,
FDA Warning Letter Issued for Missing
Verification of Compendial Methods
FDA expects compendial methods and procedures to be verified
under actual conditions of use. This became clear
during a recent inspection of a contract testing laboratory
which resulted in a warning letter. For example, the letter reads:
"Method verifications for compendial tests are not performed. Any
method, including compendial methods, must be verified as suitable
under actual conditions of use." Other citations included:
no scientifically sound and appropriate product test
specifications, no appropriate sampling plans, GC results not
traceable to raw data, original chromatograms lost, in-house
laboratory procedures non-existent or inadequate, no SOP to
ensure integrity of samples, test methods not adequately documented.
The warning letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to W-247.
To learn how to verify compendial methods
for FDA regulated environments attend the
audio seminar "Verification of
Compendial Methods according to the New USP Chapter <1226>"
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 "Retrospective Validation of Computerized
Systems". To download your free copy, go to the
Spreadsheet Compliance Package website.
Scroll down and click on the corresponding ICON on the left (offer
expires on
August 31 , 2011).
Labcompliance offers more than 130 SOPs
that help to comply with FDA and ISO 17025 compliance. For titles
and ordering, click
here.
Conferences
Audio Seminar Schedule
-
Ensuring Integrity and Security of Laboratory Data
Comply with new FDA inspection practices and EU Annex 11
requirements
September 8, 2011
-
Good Laboratory Practice Regulations
Introduction and Strategies for Implementation
September 22, 2011
-
IT Infrastructure and Network Qualification:
Step-by-Step
With Strategies and Tool Kit for Compliance and System Uptime
October 6, 2011
-
Learning from Recent Warning Letters Related to Computer
Validation and Part 11
With Clear Recommendations for Corrective and Preventive Actions
October 20, 2011
-
Cost Effective Computer System Validation: Step-by-Step
With Case Studies and IQ, OQ, PQ Protocols for Easy
Implementation
December 1, 2011
-
Validation of Analytical Methods and Procedures
Design, Conduct and Document for Efficiency and FDA Compliance
December 8, 2011
-
FDA Compliant Handling of Out of Trend Results in
Pharmaceutical Quality Control
With Strategies and best Practice Guides for easy Implementation
December 15, 2011
New or Updated Sites