Validation of Laboratory Instruments

Standard Operating Procedure Title: Validation of Laboratory Instruments

Department Validation/Technical Services Document no VAL025
Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:

Document Owner

Laboratory/Validation Manager

Affected Parties

All Technical service and Laboratory staffs involved in validation of laboratory instruments.

Purpose

To describe Validation practices for Laboratory instrument/equipment to be validated or calibrated and the confirmatory documentation required showing that the instrument/equipment is capable and operating effectively for its intended purpose.

Scope

Depending on the complexity of the instrument/equipment, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) can be performed by the qualified equipment Service Technician in the presence of the Laboratory staff with reference to the Instrument/equipment manual.

Related Documents

LAB005 Calibration Policies for Laboratories
VAL005 ValidationConcept and Procedure
QMS035 Deviation Report System

EHS Statement

Follow safety recommendations and requirements from the supplier’s manual during Installation and Validation.

Table of Contents

  1. Responsibilities During Validation .......................................................................................................... 2
  2. General Requirements............................................................................................................................ 2
  3. Installation of New Instrument ................................................................................................................ 2
  4. Method Validation Documentation .......................................................................................................... 3
  5. Certification Records............................................................................................................................... 4
  6. Post Installation Activities ....................................................................................................................... 4
  7. ReValidation and Calibration ................................................................................................................. 4
  8. Routine Maintenance and Servicing ....................................................................................................... 4
  9. Summery of Changes ............................................................................................................................. 4

This is not an approved copy unless stamped in red File Location: Date Printed: Page 1 of 4

Standard Operating Procedure Title: Validation of Laboratory Instruments

accessories received to the checklist as purchased. Confirm that the equipment is complete and in good condition. Notify the supplier/manufacture immediately of any problems found.

3.2. Setting up considerations

3.2.1. Laboratory equipment/instrumentation can be sensitive to certain environmental factors. By observing the following factors during installation, the Operator can minimise the effects of these influences where appropriate:

  • Location near output of air conditioner causing excessive drafts;
  • Direct sunlight and other high temperature locations, i.e. near an oven or furnace;
  • Vibrations through the Laboratory bench.

For further considerations always consult the instrument manual and the Equipment Service Technician/Engineer for any further requirements.

3.2.2. Some electrical precautions should be observed, (refer to the instrument manual for any special requirements for each particular instrument and consult the Equipment Service Technician):

  • Avoid using an extension cord where possible.
  • Don’t place the unit in the same circuit with large electrical motors.
  • Plug all line cords into a surge protector.

3.2.3. Observance of two basic Housekeeping rules.

  • To allow a unit to cool properly, keep the vents on the back clean.
  • Minimise the unit’s exposure to dust and provide sufficient bench space for the instrument and the computer, printer and keyboard.

3.2.4. Allow enough space nearby for sample handling.

    1. Attachment of modules
      1. Certain laboratory equipment/instruments are designed to provide full flexibility and modules can be attached.
      2. Section 1 to 3 should also be considered when installing modules.
  1. Hardware and Software orientation

3.4.1. Installation of the software may be carried out by the supplier at point of purchase or onsite installation.

4. Method Validation Documentation

    1. Validation Tests performed Inhouse
      1. The Validation documentation follows a similar format to the validation requirements of SOP VAL005, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). The extent of documentation required is dependent on the function of the particular instrument being validated. For simple instruments the Validation document can combine IQ/OQ/PQ into the one document and for more complicated equipment separate documents will be required. For particular applications only the OQ or PQ tests need to be performed.
      2. SOP VAL005 will be used as a guide when developing the validation documentation:
  1. Validation Tests provided/performed by Instrument Supplier

For validation packages provided by the instrument supplier the package must be assessed for suitability to inhouse requirements. If found to be unsuitable a new document using the appropriate inhouse format of IQ/OQ/PQ must be used by transferring the relevant useful validation protocols from the supplier’s documentation.

This is not an approved copy unless stamped in red File Location: Date Printed: Page 3 of 4

22 comments:

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Kazi said...

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The person copied the full content and published it in this blog. This blog may provide misleading information and does not comply pharmaceutical requirements.

Kazi said...

The person responsible for this blog is a cheat. This content is copyright material and published legally from www.gmpqualityup.com
The person copied the full content and published it in this blog. This blog may provide misleading information and does not comply pharmaceutical requirements.

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Kevin Petter said...

we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.

equipment validation

Andree Symond said...

Focuses on the validation of laboratory equipments used in the production of pharmaceutical products.
Determination the requirements of the end user,
which are often defined in the User Requirements Specifications.equipment validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.

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Andree Symond said...

Written cleaning procedures should be established. Attention should be addressed to dedicate certain equipment to specific products,
such as fluid bed dryer bags and to residue originating from the cleaning detergent or solvent themselves.
By packaging equipment I am referring to primary packaging equipment.


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Lee Ghirale said...

Any single group must be subjected to the 3 validation cleaning requirement,
except if a rationale is recorded and also approved by the Standard Authority
which the worst-case product of one group is clearly a worst-case product for every one of the groups.
Software validation is a part of the design validation for a finished device,
but is not separately defined in the Quality System regulation.


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Jasos Angla said...

Very well written.As the latest validation guidance is having terms like verification and testing its good to add ISO documents also in the requirements list.
The whole article gave a clear path where and how to start.
I thank the moderator for sharing such a good article.- See more at:



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Jasben Bolt said...

Standard person can validate the Equipment through calibration order.
They will check every the parameters,
Place Heat,humidity & additionally the components changed by maintenance and others.
writing is simply great,thank you for the blog.

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Lavies Dammp said...


we have probably seen the equipment before.
Our consultants will use their experience from many sites to ensure that critical to quality parameters are considered during this process.
We've seen what works and what definitely doesn't.

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Atico Export said...

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