Labcompliance News, December 2007
December 6, 2007
FDA 'Advice' on Using Spreadsheets
Excel is frequently be used in laboratories, offices and
manufacturing as sophisticated calculator Some companies
stay away from using Excel and other spreadsheets in FDA regulated
because such Out-off-the-Box software does not comply with all FDA
requirements. However, with the necessary controls Excel can be
brought into compliance. For example, the FDA has developed two
internal Information Bulletins on developing and using spreadsheets
in regulated environments. Useful advice is can also be received
from inspection reports.
Click here to see some examples and recommendations from
Labcompliance.
December 6, 2007
Agilent Technologies Compliance Services Ranked #1 - Again
In a recent blind survey mailed to LCGC subscribers, Laboratory
Decision-makers and Users ranked Agilent as their first choice for
general laboratory Compliance Services for the third time. Agilent
is way ahead to competition. The new Agilent Enterprise Edition
helps laboratories save time and money by providing a single
qualification protocol that works across an entire laboratory. For
detailed survey results and more information on Enterprise Edition
click here.
December 10, 2007
New and Revised Text of 21 CFR Part 211 Published
On Dec 4, 2008, the FDA published changes to FDA's drug GMP regulation (Part
211). As announced by FDA's Fred Blumenschein at the 2nd European GMP Conference
and reported in the Labcompliance July News this
is the first step of a phased approach to modernize GMPs. One of the most
interesting is that is mentioned several times, that for certain checks only one
signature is required if the first check is made automated equipment. For
example, § 211.103 on "Calculation of Yield" reads: Actual yields and
percentages of theoretical yield shall be determined at the conclusion of each
appropriate phase of manufacturing, processing, packaging, or holding of the
drug product. Such calculations shall either be performed by one person and
independently verified by a second person, or, if the yield is calculated by
automated equipment under § 211.68, be independently verified by one person.
December 10, 2007
New PIC/S Guide for Blood Establishments
The purpose of this document is to provide guidance for
GMP-inspectors to used during inspections of blood establishments.
However, the document does also give an insight into the thinking
and concerns of inspectorates and so could provide some useful
information for blood establishments relating to the collection,
preparation, storage, dispatch, quality control and quality
assurance of blood and blood components.. As of December 2007 the
guide can be downloaded from the
PIC/S homepage.
December 12, 2007
How Much Can You Change Compendial Method?
There have been many discussions on how much a standard method
method can be changed before it is not a standard any more. Now USP
makes recommendations in the in the updated USP chapter <621> that
has been published most recent supplement to USP 30. Horacio Pappa
of USP has informed the audience of the Middle east USP conference
about the chapter's and he also gave further information on other
changes. The chapter recommends limits for HPLC and GC papraters,
e.g.; r HPLC and GC parameters More details are available in next
Labcompliance Audio seminar. Reference material will include
SOPs of system suitability and on Change vs. Adjustment of
Compendial methods. Also Mr. Pappa's USP presentation will be part
of the seminar hand out, as well a presentation from FDA's Moheb
Nasr with tests and acceptance criteria for HPLC system suitability
testing. For more information
click here.
December 17, 2007
Site Master Files are prepared by manufacturers and contain
specific
information about the quality assurance, the production and/or
quality control of
pharmaceutical manufacturing operations carried out at the named
site and any
closely integrated operations at adjacent and nearby build. The aim
of these updated Explanatory Notes is to guide manufacturers of
medicinal products in the preparation of a Site Master File that can
be useful to the regulatory authority in planning and conducting GMP
inspections. As of December 2007 the guide can be downloaded
from the
PIC/S homepage.
December 17, 2007
Labcompliance in 2007
2007 was an other great year for Labcompliance and
website visitors: new products, new services, and significantly
increasing number of visitors were just a few highlights. We
delivered 25
audio seminars with far over 1000 attendees, we launched a new
Wed Design with a total of six tutorials.
The Labcompliance Usersclub
now includes more than 400 documents for instant downloads and the
Newsletter with the free Document of the Month enjoys more than
14,000 subscribers. We are looking forward to 2008 with more new
products. We will celebrate our 10 years anniversary and will run
our 100th audio seminar. We thank all visitors for ongoing support.
New Audio Seminars - Schedule for Q1/2008
-
System Suitability in Chromatographic Compendial Methods (188)
Understanding and Implementing Recent Changes of USP and EP
January 10, 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 and Updated Sites