Labcompliance News, January 2008
January 12, 2008
New Annex to Q8: Pharmaceutical Development
This guideline has been released for consultation under Step 2 of the ICH
process on 1 November 2007.
This guideline provides further clarification of key concepts
outlined in the core guideline. In addition, this annex describes the principles
of quality by design (QbD). The annex is not intended to establish new
standards: however, it shows how concepts and tools (e.g., design space)
outlined in the parent Q8 document could be put into practice by the applicant
for all dosage forms. Where a company chooses to apply quality by design and
quality risk management (Q9: Quality Risk Management), linked to an appropriate
pharmaceutical quality system, then opportunities arise to enhance science- and
risk-based regulatory approaches (see Q10: Pharmaceutical Quality System). The
guide can be downloaded from the
ICH Website.
January 12, 2007
FDA Uses Excel® Spreadsheets in Its Own Laboratories
Some companies don't want to use Excel® and other spreadsheets in
FDA regulated environments. Concerns are that such spreadsheets are
not accepted by the FDA. However, FDA professionals made it clear
that Excel can be used in FDA regulated environments if specific
procedures and technical controls are implemented. As a matter of
fact FDA is using Excel® in its own laboratories to comply with
their own regulations. The FDA has developed two internal
Information Bulletins that guide single and multiple users of
spreadsheets through the process. Controls include: User ID/Password
for secure log-on, MS NTFS to limit access to files, storage of
spreadsheets on write protected server directories, validation of
spreadsheet applications, control and archive of spreadsheets for
internal audits, standardizing design of templates (use of colors,
cell protection). To learn more about using Excel® in FDA regulated
environments and to receive 10+ good practices documents for easy
implementation,
click here.
January 12, 2008
No Validation of Excel Spreadsheets Draws FDA Warning Letter
The Excel Spreadsheets have been used to create and maintain non-conformance
records, product return records, internal audit records and corrective action
records. The letter stated that electronic records are used but there was no
software validation. For example, no procedures were established to validate for
its intended purpose the Microsoft Excel software. The Warning Letter can be
downloaded from the Labcompliance
Usersclub. (Scroll down to W-189). Non members can
preview excerpts. To learn everything about Excel Spreadsheet validation
attend the labcompliance
audio
seminar on February 7, 2008.
January 12, 2008
Argentina and Malta new PIC/S Members
The Pharmaceutical Inspection Convention and Cooperation Scheme
(PIC/S) announced in a press release that Argentina's and Malta's
authorities have been invited to join PIC/S as new members as of Jan
1, 2008. With these new additions PIC/S now has 33 members. The
committee also noted that Cyprus 'Pharmaceutical Services has
applied for PIC/S membership. Furthermore authorities of Indonesia
and New Zeeland announced their intention to apply membership by
2008. The committee also reviewed the progress made in the
assessment of applications submitted by France's Agency for
Veterinary Medicinal products' and by authorities from Israel,
Thailand and the US FDA. On-site assessment visits to France, Israel
and Thailand are scheduled to take place in 2008. The Press Release
can be viewed and downloaded from the
PIC/S Website
January 12, 2007
Labcompliance.com Gets Second Highest Score as The Most Relied
Website
41% of Laboratory Decision-makers and Users of
equipment ranked Labcompliance the most relied on website. This came
out of recent blind survey mailed to LCGC subscribers. The survey
question was ""What resources do you use to keep up-to-date with the
regulatory compliance?". Labcompliance.com was only beaten by
fda.gov. It is difficult to beat the US FDA in the area of
compliance.
January 12, 2007
US FDA Laboratories follow ISO 17025 Standard Procedures
Laboratories of the FDA Office of Compliance
follow ISO17025 Standard procedures to ensure quality, consistency,
and efficiency throughout the field. The Laboratory Manual (LM) is
entirely based on ISO17025 management and technical controls. As
stated in the LM it is the primary source for communicating to
laboratory staff the manner in which business is to be conducted
within the regulatory framework while carrying out the Agency's
public health mission. ISO17025 is not only an excellent Standard to
prepare for and maintain Laboratory accreditation but also to assist
pharmaceutical and API laboratories for GLP and GMP compliance.
Learn everything about ISO 17025 in a new
Audio Seminar
from Labcompliance and receive 10+ Best Practice documents for easy
implementation.
January 12, 2007
GMP Draft from 1996 Discontinued
With the publication of the new and revised text of 21 CFR Part 211 in
December 2007 the FDA announced to withdraw the draft for an updated 21 CFR Part
211 from 1996 (see Labcompliance News Dec 2007)
January 12, 2007
U.S. to Help India with Building an FDA Equivalent to the US
The U.S. Department of Health and Human Services Secretary Mike Leavitt and
Commissioner of FDA Andrew C. von Eschenbach visited Hyderabad, Indi, in the
week of Jan 10. According to a report from Validation Times on Jan 10, 2008,
India would receive technical assistance from the U.S. in developing a Centre
for Food and Drug Administration, aimed at assuring the safety of medicines and
vaccines produced in the country, Michael Leavitt said this week."We will be
discussing ways by which we can work together to assist India in developing a
Centre for Food and Drug Administration to assure that the drugs, vaccine and
other foods produced in India are safe not only for the US but also for India".
The US is interested to get lower cost drugs but at the same quality as drugs
manufactured in the US. According to the Online edition of India's National
Newspaper
THE HINDU the FDA has no plans to open an office in India
New Audio Seminars - Schedule for Q1/2008
-
Validation and Use of Excel® Spreadsheets in Regulated
Environments
(187)
Comply with GxPs, Part11, HIPAA, SOX and other regulations.
February 7, 2008
-
Understanding and Implementing ISO 17025 (189)
Requirements, Strategies and Tool Kits for Laboratory
Accreditation
February 14, 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
New or Updated Sites