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| Data Integrity App |
Question 01:
What is ‘grand fathering’?
Best Answer: “Grand fathering” simply means the
possibility that the rule may not apply to any system in existence before the
rule came into effect.
Part 11 does not allow for
grandfathering of legacy systems. Therefore, systems installed before August
20, 1997 must be made compliant or replaced.
Question 02:
What is GxP?
Best Answer: This refers to the “Good Practices”
whose rulings are observed within the pharmaceutical industry.
These are Good Laboratory Practice
(GLP), Good Automated Manufacturing Practice (GAMP), Good Manufacturing Practice
(GMP) and Good Clinical Practice (GCP). The ‘x’ is merely a placeholder.
Question 03:
What is a ‘Predicate Rule’?
Any requirements set forth in the
Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service
Act), or any FDA regulation (GxP: GLP, GMP, GCP, etc.).
Best Answer: The predicate rules mandate what
records must be maintained; the content of records; whether signatures are
required; how long records must be maintained, etc.
If there is no FDA requirement that
a particular record be created or retained, then 21 CFR Part 11 most likely
does not apply to the record.
Are HIPAA regulations considered a
predicate rule with regard to medical records maintained electronically?
Question 04:
What is ‘Metadata’?
Best Answer: Literally, it can be defined as
‘data about data’.
In practical terms, the types of
metadata that can be associated with an electronic record may include: details
of the record’s creation, author, creation date, ownership, searchable keywords
that can be used to classify the document, details of the type of data found in
the document, and the relationships between different data components.
Metadata must be stored as an
integral part of the electronic document it describes.
Question 05: What is a Recall?
Recalls
are actions taken by a firm to remove from the market any product that is in
violation of laws
Best Answer: administered by the FDA. Recalls of a drug may be conducted on a firm’s own initiative or by FDA request.
Question 06:
Can FDA mandate a recall of human
drugs?
FDA
does not have authority to mandate a recall of a human drug, but it can take
more authoritative
Best Answer: legal
actions against manufacturers that persist in marketing a defective product,
such as seizure and
injunction.
A
recall is a firm’s removal or correction of marketed product that FDA considers
to be in violation of
the
laws it administers, and against which FDA would otherwise initiate more
powerful legal action
Question 07:
Is it possible for a user to have two system accounts? One as a
user and one as administrator or reviewer?
Best Answer: Yes, in small organizational units. Guarantee by means of an SOP that the admin
account will NOT be used operationally.
Question 08:
How exact must GMP
functionalities be described in the inventory?
Best Answer: In
the inventory, a description of the general functions is sufficient, i.e.
archiving of data, parts list management etc. Detailed information can be found
in the system description.
Question 09: Data flows – does
this also mean intersystem interfaces (for example, the interfaces between
different modules in ERP- systems)?
Best Answer: Every
intersystem interface should be described, including any relevant changes of
data format.
Must
all user requirements be traceable or only the ones classified as being
GMP-relevant?
User
requirements, especially those classified as being GxP-critical should be
traceable in order to
evaluate
whether the computerized system is fit for the respective purpose.
Question 10: What should test
scripts and test results look like in order to be accepted by the inspectors?
Best Answer: Test
scripts should contain a specification (expected result) and a description
(test performance). The
test
result should indicate whether the specifications are fulfilled. Failed tests
must be evaluated.
“Trust but Verify “ Ronald Reagan
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
- Basic Data Integrity Concepts
- ERES & Its Requirement
- CSV & Its best practices
- Mock Inspection and General Q&A
- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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