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Raising of Deviations (IQ/OQ)

Hi,

I am of the opinion that a deviation should be raised during an IQ/ OQ where there is a breach of an acceptance criteria laid down / specified. However, our course of action is to fix and retest.
Can anyone comment as to why this is poor practice?

Also safety of product and personnel are important and should be assessed as part of the IQ. Should this be addressed in the IQ?

Thank you for your time.

Austin

[quote=Austin Stewart]Hi,
I am of the opinion that a deviation should be raised during an IQ/ OQ where there is a breach of an acceptance criteria laid down / specified. However, our course of action is to fix and retest.
Can anyone comment as to why this is poor practice?
[/quote]

Yes, I agree with this. Our usual way of implementing this change is to complete the full validation first, list all of the deviations from acceptance criteria in the section for this, then deal with this deviations in a revalidation assessment form where it it dertailed how we will fix the deviaotions and what part of the protocol has to be re-executed in order to do this.

[quote=Austin Stewart]Hi,
Also safety of product and personnel are important and should be assessed as part of the IQ. Should this be addressed in the IQ?
[/quote]

Yes the IQ seems to be the mosy logical place for this, but as long as it is addressed somewhere in a protocol then I would be satisfied.

Dear Austin,
Deviations must be record and reported during each qualification studies, and try to rectify these deviations before initiation of further steps if possible.

safety feature of personnals, equipment and product should be covered in Installation quakification section.

Thank

Dear Austin,
Deviations must be record and reported during each qualification studies, same time we shall checked criticallity of deviation observed, if we can not rectify it then accordingly we can re-think for URS also.

Finally equipment shall be declared as a qualified after suitable with our URS.

Safety feature of personnals, equipment and product should be covered in quakification.This is essential part of qualification activity.

Thank

Dear friends,

Deviations must be recorded and reported during IQ/OQ, as those are the part of qualification activity / document.

We need to record the deviations which are not complying with URS, Design Specifications, Functional Specifications & Design Qualificaiton.

Question:
Also safety of product and personnel are important and should be assessed as part of the IQ. Should this be addressed in the IQ?

Ans:
Safety features of equipment can become a part of OQ only. It will NOT be a part of IQ.

Because, in IQ, we identify the Major / Critical Components for its identifiation. Whereas in OQ, we do the Functional / Operational checks, Safety checks, Alarm checks, Interlock checks.

Hence, don’t include the features of Safety in IQ.

Thanks & Regards,
Y.S. Reddy

Hi Austin,

I have had numerous workshops in this regard an do not believe that a deviation can exisit during the process of Validation. As with Company change control, deviaitons can only be initiated against a controlled system - While a non-compliance to acceptance criteria exists under the qualification process, it should be deemed an ‘Outstanding issue’ and addressed accordingly.

Again, you can only ‘Deviate’ from a controlled process - Until a system is Validated fully, it is not in a state of control.

:cool:

Dear All
I have gone through all the comments above and come to on conclusion that all the deviations noted during IQ, OQ and PQ should be covered in Validation summery report, simply a Validation Summary Report provides an overview of what was accomplished and concludes the documentation. Yes as advised above Results of execution,Deviations and observation noted should be covered, and on the basis of this the action plan is decided by validation team.
Safety of personnel and equipment is always covered in IQ.

Dear Sudarsan,
Here below the definition and scope of IQ and OQ.
Installation qualification (IQ):
Document that the equipment is properly installed according to the manufacturer and purchaser’s specifications. It covers equipment /system descriptions, which includes principle of operation, design requirements, equipment specifications piping, instruments diagrams, facility functional specifications, equipment utility requirements, and equipment safety features.

Operational qualification (OQ):
Document that the equipment operates within established limits and tolerances. It covers equipment operation procedures established and challenged equipment control functions, calibration requirements and schedules established, and maintenance requirements.

[COLOR=“Red”]so safety features should be checked during Installation, here is the example of safety feature checks during installation.
[/color]for e.g
S. no. Safety features Status (Y/N)

  1. Personnel protection from rotary vial washer ensured
  2. All the electrical work conforms to local codes
  3. Safety valves are installed

Dear Shahnawaz,

Please observe the answer, which was given by me.

Ans:
1)Safety features of equipment can become a part of OQ only. It will NOT be a part of IQ.

  1. Because, in IQ, we identify the Major / Critical Components for its identifiation. Whereas in OQ, we do the Functional / Operational checks, Safety checks, Alarm checks, Interlock checks.

  2. Hence, don’t include the features of Safety in IQ.

Reason for the above explanation:
It meant to say that, you can identify the Safety features in IQ. But, the checking of Safety features i.e. whether it works or not, should be the part of OQ only.

Just observe my point number: 2

It means, you have to identify the Major / Critical components, even it includes the Safety features i.e. it is the part of identification only.

Note: Could you please let me know, what is the reference of the definition that what you mentioned for IQ.

References:

EU guidelines on Eq.Qualification
GMP on Qualification & Validation - EU Annexure 15
PIC/s guidelines on qualification

Dear sudarsan,

7.1 Installation qualification (IQ)
This document should be written for the critical processing equipment and systemsthat are used within the facility, e.g. an HVAC system, an autoclave or a pH meter.
The IQ should list all the identification information, the location, utility requirementsand any safety features of the equipment.The IQ protocol prepared for each piece of equipment or system lists the name, description,
model and identification numbers, the location, utility requirements, connections,
and any safety features of the system/equipment which need to be documented.
See Section 7.1 (WHO guide to good manufacturing practice (GMP) requirementsPart 2: Validation (WHO/VSQ/97.02)


You can see another reference at
http://asiahwp.org/upload/id186/Process%20Validation%20Guidance%20for%20Medical%20Device%20Manufacturers.pdfslide
no 41/68
(Process validation guidelines (Christine Nelson FDA centre for device and radiological health)


Validation - The Essential Quality Assurance Tool For Pharma Industries

Written by Prof.S. Saraf et.al

Wednesday, 07 December 2005


http://books.google.com/books?id=QdU_W4QcNnUC&pg=PA117&lpg=PA117&dq=equipment+safety+features+in+installation+qualification+fda&source=web&ots=e-I9hY7mmR&sig=6k-qTRWZqniQ-3YCdWlCS_O3ras

by Pharmaceutical Maser validation Plan by Imtiaz haider


These are following references are avialable.

Thanks and best regards,

Dear Shahnawaz
Very informative post and authentic references.

Dear Sudhershan
you gave the reference of PIC/S guideline on Equipment Qualification, anyway there is no PIC/S guideline exists typically on Equipment Qualification, Yes PIC/S covers Validation and Qualification in PE 009-7 (Annexes) 1 September 2007, Annex 15 Qualification and validation.

[COLOR=“blue”]Installation qualification
11. Installation qualification (IQ) should be performed on new or modified facilities,
systems and equipment.
12. IQ should include, but not be limited to the following:
a) installation of equipment, piping, services and instrumentation checked
to current engineering drawings and specifications;
b) collection and collation of supplier operating and working instructions
and maintenance requirements;
c) calibration requirements;
d) verification of materials of construction.[/color]

Point B emphesize on operating and working instructions and maintenance requirement, which covers safety features of equipment as well.

[COLOR=“blue”]Operational qualification
13. Operational qualification (OQ) should follow Installation qualification.
14. OQ should include, but not be limited to the following:
a) tests that have been developed from knowledge of processes, systems
and equipment;
b) tests to include a condition or a set of conditions encompassing upper
and lower operating limits, sometimes referred to as “worst case”
conditions.
15. The completion of a successful Operational qualification should allow the
finalisation of calibration, operating and cleaning procedures, operator training
and preventative maintenance requirements. It should permit a formal "release"
of the facilities, systems and equipment.[/color]

Hope this will clear the concept.

Hi,
Thank you all for your input. I am not surprised by the degree of variation in the responses. For me, having worked in validation for numerous years at this stage I would tend to lean towards approaching safety of equipment from an IQ standpoint - ensuring allsafety features are there and then checking them from an OQ perspective. I suppose my simple take on IQ against OQ is that one is performed in the ‘off’ position whilst the other is ‘on’. I think that this company will need to implement validation policy in order to cement the thinking on this issues.

Many thanks.

Austin
:cool:

I agree with Austin and Shahnawaz.

Even URS, DQ should include safety features and the same will be verified at IQ and functionally checked at OQ stage.

Thanks and Regards
SM

Dear Friends,

Thanks for the technical explanation.

Even i have proposed the same. (Identification of safety features means, it should be identified and documented, which is a part of IQ).

Hope, it is clear now.

Regards
Sudarshan