Labcompliance News, May 2010
FDA's Updates the
Preapproval Inspections/Investigations Manual
FDA released a new version of the "Preapproval
Inspection" Compliance Program Manual. The guide is targeted to
inspectors but equally useful for inspected (Bio)Pharmaceutical
industry. In addition to information on how inspections are prepared
and conducted the guide also has lots of recommendations on what
inspectors should specifically look at. Some of them are also
applicable to routine cGMP inspections. Most interesting is the
chapter on Raw Data Integrity with examples of data integrity
problems that have been previously observed. They include:
"Manipulation of a poorly defined analytical procedure and
associated data analysis in order to obtain passing results",
"Exclusion of specific lots from the stability program to avoid
submitting failed results", "Creating acceptable test results
without performing the test" and "Using test results from previous
batches to substitute testing for another batch". Inspectors are
advised to "Audit the raw data, hardcopy or electronic, to
authenticate the submitted data. In a new
audio seminar attendees will learn how
to define, manage and demonstrate integrity of electronic raw data.
The manual can be downloaded from the
FDA website.
FDA-483 with 11 Observations
Related to QC Laboratory Controls
The 483-Form has been handed over in the
inspection close-out meeting to management of a pharmaceutical
manufacturer. It is perfect case study to learn what can go wrong.
Most observations are related mto inadequate supplier qualification,
inadequate testing of raw material, inadequate SOP for OOS, lack of
process validation, inadequate deviation from SOPs before
authorization from management, lack of sampling plans, no
justification for changing environmental conditions, test conditions
not documented, no justification for only one cleaning validation
run, test acceptance criteria not justified, no risk assessment
performed to evaluate effect of deviations from SOPs, supplier's
test results of components not validated. The FDA-483 can be
downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-234. Learn all about FDA GMP requirements related to quality
control laboratories and how to avoid 483's in the Labcompliance
audio seminar
PIC/S Publishes Example for
Quality Risk Management Implementation
Since a couple of years Quality Risk
Management (or QRM) has become a mandatory regulatory requirement
towards healthcare organizations either they are active in the
sectors of Medical Devices or in Pharmaceuticals. However, the
practical methods for the implementation of these new requirements
are still perceived as being singularly difficult to interpret and
implement. Now an informal Working Group within PIC/S has developed
an example of methodology for the implementation of Quality Risk
Management (QRM) in industry. The example
can be downloaded from the
PIC/S website.
Labcompliance ISO 17025
Tutorial Updated
We have updated the popular tutorial for ISO 17025.
Now it includes a management summary and a section with specific
recommendation for implementation, for example, equipment verification,
measurement traceability and measurement uncertainty. It also includes a
step-by-step approach for getting accreditation and recommendations for
internal and external audits. To access the free tutorial,
click here.
3
Inspectional Observations Related to FDA's Dietary Supplement GMP's
FDA has started to enforce 21 CFR 111, FDA's
GMP Regulation for 21 CFR 111. An example are three FDA-483
Inspectional Observations going to a manufacturer of dietary
supplements. Deviations are related to Incomplete records of
equipment cleaning and sanitation, raw material weight records
incomplete, inadequate hygienic conditions. For example the
observation state: "You did not make and keep documentation of the
date of use, cleaning and sanitizing of the equipment used to
prepare coating solutions for dietary supplement tablets", and "Your
batch production records did not include the actual results obtained
during a monitoring operation, Specifically, records for monitoring
raw material in the weight room did not include each partial raw
material weight and the identification of the equipment used", and
"Your personnel did not use hygienic practices to the extent
necessary to protect against contamination of dietary supplement
ingredients. Specifically your personnel did not wear outer garments
in a manner that protects against contamination of dietary
supplement ingredients". The FDA-483 can be downloaded from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-233. Learn all about 21 CFR Part 111 requirements and how to
avoid 483's in the Labcompliance
audio seminar
FDA Publishes Guidance
for Industry: ICH Q8, Q9, and Q10 - Questions and Answers
Since the Q8, Q9, and Q10 guidances were made
final, experiences implementing the guidances in the ICH regions
have given rise to requests for clarification. This new FDA question
and answer (Q&A) document is intended to clarify key issues. The
guidance reflects the current working procedure of the ICH Quality
Implementation Working Group (Q-IWG) for implementing the Q8, Q9,
and Q10 guidances. Discussions are related to process validation,
quality by design, design space, real time release testing vs.
product end-testing, benefits of pharmaceutical quality system,
adjusting of process parameters throughout the product life-cycle,
and others. The guide can be downloaded from the
FDA website.
FDA Inspection Reports -
Ideal Case Studies for Dietary Supplement GMPs
FDA Establishment Inspection Reports (EIR) are
quite useful to learn about the complete inspection process, e.g.,
who is interviewed, where the inspection focus is, what documents
are reviewed, what questions are asked and if the answers are
satisfactory. This is especially important for new regulations with
little information on what FDA's interpretation. A good example is
an EIR related to the new FDA's new GMP regulation for Dietary
Supplements.
The EIR includes all aspects of the regulations. Specific sections
are: Persons interviewed (by function),
personnel, training, physical plant and grounds, cleaning and pest
control, equipment calibration and sanitation, production and
process control, examination of incoming material, quality control,
qualification of suppliers, COA, handling returned dietary
supplements and customer complaints, review of batch records by QA,
laboratory testing, packaging and labeling operation, avoiding
product contamination during holding and distribution, closing
discussion with QA manager, The company passed the inspection
without any inspectional observations. The EIR can be downloaded
from the
Labcompliance Usersclub. Non members can
preview excerpts. Scroll down to
W-235. Learn all about 21 CFR Part 111 requirements and how to
avoid 483's in the Labcompliance
audio seminar
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: Validation of Spreadsheet Applications. To
download your free copy, go to the
Spreadsheet Compliance website. Scroll down and click on
the corresponding ICON on the left (offer expires on May 10, 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
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Implementing FDA's 21 CFR 111 for Dietary Supplements
Introduction, Strategies and Tool-kit for Implementation
May 27, 2010
-
Electronic Raw Data in Regulated Environments
Definition, generation and archiving for FDA Part 11, HIPAA and
SOX compliance
June 10, 2010
-
GMP Compliance for Quality Control Laboratories: Step-by-Step
FDA Requirements and Tools for Implementation
June 24, 2010
-
Analytical Instrument Qualification According to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
July 8, 2010
-
Recent Warning Letters and 483's Related to Computer Validation
and Part 11
With Case Studies to Avoid and Respond to 483's and Warning
Letters
July 22, 2010
New or Updated Sites