Labcompliance News, October 2010
Spreadsheets should be Verified
for Accuracy and Calculations Should be Documented, FDA Warning
Letters says
Spreadsheets such as Excel used in FDA regulated environments
should be verified for accuracy and calculations used in the
spreadsheet program should be documented.
This became clear during a recent inspection of a prescription drug
manufacturer which resulted in a warning letter. For example, the
letter reads: "You continued to release products based on assay
results generated by the spreadsheet that have not been verified for
accuracy.". Furthermore the FDA noted that: "Your laboratory records
did not include a record of all calculations performed in connection
with laboratory tests as required by 21 CFR §211.194(a). For
example, the notebook does not document reference to the spreadsheet
calculation used to generate the results. Your SOP omits
instructions to include in the notebook the reference to the
spreadsheet calculation used to generate the results, as well as the
raw data and calculations." The warning letter can be downloaded
from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-237. To learn how to validate Excel Spreadsheets for FDA
regulated environments attend the
audio seminar "Validation of Excel Spreadsheets in Regulated
Environments".
Do all EU GMP
Inspections Cover the Quality Risk Management Process?
The UK Medicines and Healthcare Products Regulatory Agency (MHRA)
published a set of Q&As related to the GMPs and Quality Risk
Management. The first question was "Do all
EU GMP Inspections Cover the Quality Risk Management Process". The
answer is a clear yes. Quality risk management is part of the
Quality system that is included in all GMP inspections. "Inspectors
will review the QRM system as part of the Quality Systems section of
the inspection (along with complaints, recalls, deviations, and
product quality reviews etc).". The Q&As are published on the
MHRA website.
Again and Again, Part 11 Related
Deviations Cited in FDA Warning Letter
During an inspection of pharmaceutical
manufacturing facility the FDA found several deviations related to
Part 11. Multiple persons had access to one user account. The letter
states "Your firm has not exercised appropriate controls over
computer or related systems to assure that changes in control
records or other records are instituted only by authorized
personnel. For example, one user account is established for two
analysts to access the laboratory instrument's software on the
computer system attached to HPLC systems" In addition, the
user accounts provided full system administrative rights.
Furthermore, there were no data security protocols that describe the
user's roles and responsibilities in terms of privileges to access,
change, modify, create, and delete projects and data. The Warning
Letter can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-242. To learn everything about FDA' new inspection practices
attend the
audio seminar " How to Prepare Yourself for FDA's New Part
11 Inspection Program".
FDA Issued Final Rule on
Safety Information During Clinical Trials
On September 28, 2010, the Food and Drug Administration issued final
regulations addressing the safety reporting requirements for
investigational new drug applications (INDs) found in 21 CFR part
312 and for bioavailability and bioequivalence studies found in 21
CFR part 320. This
final rule is expected to improve the quality of safety reports
submitted to FDA, thereby enhancing the safety of patients in
clinical trials. The final rule lays out clear, internationally
harmonized definitions and standards so that critical safety
information about investigational new drugs will be accurately and
rapidly reported to the agency, minimizing uninformative reports and
enhancing reporting of meaningful, interpretable information. Along
with this final rule, the FDA also issued a
draft guidance for industry and investigators that provides
information and advice about the new requirements and other
information. In addition, FDA published
Q&As related to the new rule.
New Part 11 Compliance Package
Available as Download
The popular Labcompliance Part 11 Package is now
available as download version, in addition to traditional CD/Binder
Version. The content has also been updated with new 9 SOPs, two new
audio seminars, 8 new forms and 4 new case studies for trouble free
implementation. The new package is ideally suited to prepare
companies for upcoming FDA Part 11 inspections with focus on
security, integrity and availability of e-records. For example,
checklists, the step-by-step implementation plan and procedures have
been updated accordingly. For details on content and
ordering,
click here.
FDA 'Advice' on
Validation and Use of Excel®
Excel is frequently 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 also is
received from FDA inspection reports. The new Annex 11 for EU GMP's
and GAMP®5 also include chapters on
Spreadsheets. To learn everything about FDA's and other regulatory
expectations and enforcement practices for using Excel
click here.
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 "Handling of Laboratory Test Samples". To
download your free copy, go to the
Laboratory Compliance Package website. Scroll down and click on
the corresponding ICON on the left (offer expires on October 4,
2010). Labcompliance offers more than 120 SOPs that help to comply
with FDA and ISO 17025 compliance. For titles and ordering, click
here.
Audio Seminar Schedule
-
Validation of Excel® Spreadsheets for Regulated Environments:
Step-by-Step
With Case Studies and Validation Protocols for Easy
Implementation.
October 28, 2010
-
How to Prepare Yourself for FDA's New Part 11 Inspection Program
Learn what the FDA is looking for and how to respond
November 11, 2010
-
Validation of Existing/Legacy Computer Systems for FDA/EU
Compliance
FDA/EU requirements and strategies and tools for implementation
November 18, 2010
New or Updated Sites