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| Data Integrity App |
Question 01:
Should the scope and extent of validation be based on risk?
Best Answer: Yes, the scope and extent of validation should be based on risk according to the manufacturer's quality risk management procedures. Qualification and validation work is required to control the critical aspects of the particular operation and a common sense approach should be applied.
Question 02:
Is performance qualification (PQ) required to be carried out for each item of critical process equipment, if process validation is performed on the same equipment?
Best Answer: PQ is required to be preceded by IQ and OQ.
For significant changes to equipment (eg. for new or modified items of equipment), the PQ is separate from and precedes process validation.
For minor changes not impacting on already qualified equipment (eg. to processing parameters only), process validation could be integrated in PQ and a repeated IQ and OQ may not be necessary.
Question 03:
What is the
definition of “relevant systems”?
Best Answer: Relevant / Substantial systems are systems used in order to implement or assist GMP requirements. These systems can be identified within the context of a risk analysis.
Question 04:
04 Is there a definition for “critical”?
Best Answer: No,
but Annex 11, chapter 1 gives an indication. Critical systems are systems that
directly or indirectly influence patient safety, product quality and data integrity.
Question 05:
Are there any specific considerations for the validation of spreadsheets?
Best Answer: Validation according to paragraph 4 of annex 11 is required
at least for spreadsheets that contain custom code (e.g. Visual Basic for
applications).
Formulas or other types of algorithm should be verified for
correctness.
Question 06:
Are user requirements needed as part of the retrospective validation of legacy systems?
Best Answer: The way to check whether a computerised system is fit for
its intended purpose is to define user requirements and perform a gap analysis
to determine the validation effort for retrospective validation. These user
requirements should be verified.
Question 07:
When do I have to
revalidate computerised systems?
Best Answer: Computerised systems should be reviewed periodically to confirm that they remain in a validated state. Periodic evaluation should include, where applicable, the current range of functionality, deviation records, change records, upgrade history, performance, reliability and security.
The time period for revaluation and revalidation should be
based on the criticality of the system.
Question 08:
What are the
relevant validation efforts for small devices?
Best Answer: Small devices are usually off-the-shelf pieces of equipment
that is widely used. In these cases, the development life-cycle is mainly
controlled by the vendor.
The pharmaceutical customer should therefore reasonably
assess the vendor’s capability of developing software according to common
standards of quality.
A vendor assessment needs to be performed and the
application needs to be verified against the requirements for the intended use.
From the perspective of the regulated industry, the implementation of such a
device is driven by an implementation life-cycle.
At minimum the following items need to be addressed:
·
requirement definition for the intended use including process limitations. This
should also include a statement indicating whether data are stored or
transferred to another system. As per the definition of a small device, data
are not stored permanently but temporarily and are not to be modified by a
user.
Therefore, limited user access handling is acceptable. It
needs to be ensured that parameter data influencing the device's behaviour may
not be altered without suitable permission;
· risk
assessment, taking into consideration the intended use and the risk to patients
for associated with the process supported by the small device;
·
vendor assessment;
· list
of available documentation from the vendor, especially those describing the
methodology used and the calculation algorithm, if applicable. A vendor
certificate or equivalent detailing the testing performed by the vendor may
also be included;
·
calibration certificate, if applicable;
·
validation plan according to the risk-assessment results;
·
verification testing proving that the device fulfills the requirements for the
intended use. It may be equivalent to a PQ-phase.
Small manufacturing devices are sometimes only equipped with
microprocessors and firmware and are not capable of high-level administration
functions. Moreover, data is often transient in nature in these devices. Due to
the latter there is no risk of inadvertently modifying data. An audit trail is
therefore not necessary and user access may be limited to those functions of
parameter control.
Question 09:
What levels of control are expected when using automated test tools?
Best Answer: The level of control results from the criticality of the systems tested and the type of test tools used. A complete validation is not generally expected.
Question 10:
To what extent must the erroneous entering of data be checked during validation?
Best Answer: It depends on the criticality of the entry. If the entry of critical data is to be checked not by a second operator but by a validated electronic means, it should be checked during validation whether erroneous entries really are detected
“Trust but Verify “ Ronald Re
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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
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- Checklist for inspection
- Inspection Readiness
- Useful SOP’s
- Stay Regulatory Compliant.
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