How to prepare an Installation Qualification in 3 steps.

Installation Qualification

 

WHAT IS AN INSTALLATION QUALIFICATION IQ?

The FDA definition of installation qualification is: “Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer recommendation is suitably considered.”

The IQ document demonstrates if the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.

INSTALLATION QUALIFICATION PREPARED IN THREE (3) STEPS

Step 1. Protocol Preparation and approval.

Step 2. Protocol Execution and review.

Step 3. Final Report Preparation and approval.

The requirements to properly install the system is pre-defined in the Design Specification.

WHAT MAY INCLUDE THE INSTALLATION QUALIFICATION PROTOCOL

The IQ protocol may include, but, is not limited to the following sections, (as applicable)

  • Purpose
  • Scope
  • Background
  • Hardware Description
  • Infrastructure Identification
  • Associated Documents
  • Definitions and Acronyms
  • Hardware Identification, Installation, And Configuration Verification Instructions
  • Test Steps and Hardware Identification, Installation, And Configuration Verification
  • Hardware Inspection and Testing Verification (as applicable)
    • Location of install and necessary floor space
    • Documentation any and all computer-controlled instrumentation
    • Gathering all manuals and certifications
    • Properly unpacking and cross-checking instruments
    • Examining instruments and components for damage
    • Ensuring correct power supply: Source Electric Power: [Hz, Amps, Vac, Ground]
    • Installing ancillary instruments
    • Documenting firmware versions and serial numbers
    • Environmental and operating conditions, Operating Temperature and % Relative Humidity
    • Checking software system installation and accessibility
    • Recording calibration and validation dates of tools used for IQ
    • Verifying connections and communication with peripheral units
    • Firmware Bios (Updated) and Operating System OS (Updated)
    • RAM Memory and Cache Memory
    • CPU Name, Cores, Type, Speed
    • Hard Drives Internal, Type, Space, etc.
    • Service Clearance / Mounting
    • Security/Privacy Protection Enabled and Password Protection: Vulnerability Test
    • Accounts/Username/Password and Encryption Name, Type, etc.
    • Physical Access Protection and Fail-Over/Redundancy Feature
  • Analysis of Test Results
  • Acceptance Criteria
  • Incident Reports Summary
  • Conclusions and Recommendations
  • Final Resolution and Release
  • Associated Reference Documents
  • Appendices
  • History of Change
  • Document Approval

What makes IQ successful?

Successful IQ must demonstrate that the installation process followed the manufacturer’s guidelines and met their requirements.

Installation Qualification must be performed before completing the Operational Qualification or Performance Qualification.

Depending on the size of the system, Installation Qualification can be combined in one protocol, execution, and report with Operational Qualification or Performance Qualification.

Installation Qualification protocols should be approved before protocol execution to comply with the prospective validation approach.

A copy of the unexecuted protocol should be kept in the validation package.

The unexecuted protocol should be approved at least by the protocol author, system owner, and quality assurance representative.

The final report of the executed protocol should be signed at least by the tester and reviewed by the system owner and quality assurance representative.

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Three (3) options to create an Installation Qualification Protocol

Option 1. You can create a great protocol, using a template.

You can download a free sample of an installation qualification template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create a customized installation qualification.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.

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STATUTORY AND REGULATORY REQUIREMENTS

Validation for drugs (finished pharmaceuticals and components) is a legally enforceable requirement under section 501(a)(2)(B) of the Act (21 U.S.C. 351(a)(2)(B)), which states the following:

“… a drug (including a drug contained in a medicated feed) shall be deemed to be adulterated if the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirement of the act as to the safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.”

References

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

https://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

httpss://www.fda.gov/media/94074/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://ispe.org/publications/guidance-documents/gamp-5

Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!