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Installation Qualification Protocol for Pharma Equipment

Last reviewed 19 Oct 2026 · 7 min read

Contents
  1. Purpose and scope
  2. Responsibilities
  3. IQ protocol
  4. 1. Protocol identification
  5. 2. Define system boundaries and criteria
  6. 3. Installation verification checklist
  7. 4. Execution and deviation handling
  8. 5. Report and conclusion
  9. 6. Approval and release
  10. Related US cGMP provisions, where applicable
  11. Frequently asked questions
  12. Is an IQ the same as OQ or PQ?
  13. Does Annex 15 prescribe one IQ checklist for all equipment?
  14. When should a relocation trigger a new IQ?
  15. See also
  16. References

In short: This is an illustrative installation qualification (IQ) protocol and report template for pharmaceutical facilities, systems and equipment. Adapt its checks and acceptance criteria to the approved design, intended use, risk assessment and applicable quality system before use.

Purpose and scope

Use an IQ to document that a new or modified facility, system or item of equipment has been installed in accordance with its approved design and the manufacturer’s recommendations. EU GMP Annex 15 describes IQ for new or modified facilities, systems and equipment and lists installation checks, supplier instructions, calibration requirements and materials of construction among the checks to consider. (EudraLex Volume 4, Annex 15 (2015), §§3.8–3.9.)

This template does not set universal acceptance limits or make an equipment-specific protocol unnecessary. Define the scope and criteria from the approved design and intended use. In the United States, 21 CFR 211.63 separately requires equipment used for drug-product operations to be appropriately designed, adequately sized and suitably located for intended use, cleaning and maintenance. (21 CFR 211.63, current eCFR)

Example in-house criterion (not a pharmacopoeial requirement): Assess a relocation through change control and document whether it requires full or partial requalification.

Responsibilities

  • Protocol owner or subject-matter expert: Define the equipment boundary, approved references, checks, methods and acceptance criteria.
  • Engineering or installer: Provide installation details, current drawings, supplier instructions, service information and completed check records.
  • Quality unit: Ensure protocol and report approval by appropriate personnel under the pharmaceutical quality system, and authorize progression to the next qualification stage as applicable. (EudraLex Volume 4, Annex 15 (2015), §§2.2, 2.10.)
  • Executor and verifier: Record the work performed and evidence reviewed; ensure the independent verification described by the approved site procedure is completed.

IQ protocol

1. Protocol identification

Complete the fields before execution:

FieldInformation to record
Protocol title and numberApproved document title and controlled identifier
Revision and effective dateCurrent controlled revision
Equipment or systemName, asset or inventory number, manufacturer, model and serial number
Location and intended useBuilding, room or area and the approved function
Installation or change referencePurchase order, change-control record or project identifier
Related documentsApproved user or functional requirements, drawings, specifications and relevant procedures
Protocol approvalNames or roles, signatures and dates required by the site’s document-control process

2. Define system boundaries and criteria

Describe the system and its main components, interfaces, controls, instruments, connected services and supporting utilities. Identify what is inside and outside the IQ scope. List the current approved drawings and specifications against which installation will be checked.

For each check, state the method, evidence to collect and acceptance criterion before execution. Criteria should be traceable to the approved design, manufacturer’s instructions or another justified source. EudraLex Annex 15 says protocols should define the critical systems, attributes or parameters and associated acceptance criteria; it also requires qualification documents to be approved and authorized by appropriate personnel. (EudraLex Volume 4, Annex 15 (2015), §§2.2, 2.4.)

3. Installation verification checklist

Use this table as a starting point. Add or remove checks only with a documented rationale for the equipment and approved protocol.

CheckEvidence to review or recordAcceptance criterion and result
Equipment identity and configurationNameplate, asset ID, model, serial number and installed configurationCompare with the approved specification
Components, instruments, pipework and servicesPhysical inspection, component list and current engineering drawingsConfirm installation against approved drawings and specifications
Supplier documentsOperating and working instructions, maintenance requirements and relevant certificatesIdentify and file the current documents required for intended use
InstrumentationInstrument ID, range, calibration status and supporting calibration recordsConfirm requirements defined by the approved protocol are met
Materials of constructionSupplier certificates or other approved material evidence for specified partsCompare with the approved design or material specification
Utilities and connectionsConnection identity, direction where applicable, and documented inspectionVerify each connection against the approved design
Deviations or outstanding itemsDeviation number, description, impact assessment and resolution evidenceResolve or formally assess before the report recommends progression

The checklist reflects the types of IQ checks listed in EudraLex Volume 4, Annex 15 (2015), §3.9. It is not an exhaustive list for every system.

4. Execution and deviation handling

  1. Execute the approved protocol and record results against the pre-defined criteria. Identify the person performing and checking each activity as required by the site procedure.
  2. Reference supporting evidence by controlled document number, attachment or data-record identifier. Do not replace a result with an unsupported statement that a check passed.
  3. Record any failed check, missing evidence or departure from the approved protocol as a deviation. Investigate and assess its effect on the system and next qualification activity. Annex 15 states that results failing pre-defined criteria should be recorded and investigated under local procedures, with implications discussed in the report. (EudraLex Volume 4, Annex 15 (2015), §§2.7–2.9.)
  4. Document any protocol change during execution, including its justification and impact. Do not change acceptance criteria retrospectively to make a result pass. (EudraLex Volume 4, Annex 15 (2015), §2.7.)

5. Report and conclusion

The IQ report should identify the protocol and equipment, summarize the checks performed and evidence reviewed, list deviations and their disposition, and state whether the approved acceptance criteria were met. Include or reference the completed checklist, drawings or specifications used, calibration or material evidence, deviation records and any other supporting data.

The report should state a clear conclusion on the installation and identify any open actions. EudraLex Annex 15 calls for results and conclusions to be reported against acceptance criteria and for progression to the next qualification stage to be authorized by responsible personnel. OQ normally follows successful IQ, although Annex 15 notes that an IQ/OQ combination may be appropriate depending on equipment complexity. (EudraLex Volume 4, Annex 15 (2015), §§2.9–2.10, 3.10.)

6. Approval and release

Example in-house criterion (not a pharmacopoeial requirement): Use the site’s approval page to record the protocol owner, executor, verifier and Quality review, with signatures and dates. This example does not replace the site’s document-control requirements.

Do not treat completion of an IQ checklist alone as approval to use a system. Qualification documents must be approved and authorized by appropriate personnel defined in the pharmaceutical quality system, and release to the next stage must be authorized by responsible personnel. (EudraLex Volume 4, Annex 15 (2015), §§2.2, 2.10.)

For drug products within the scope of 21 CFR Part 211, equipment design, size and location are addressed in §211.63. Section 211.67 covers equipment cleaning and maintenance procedures and records. Section 211.68(a) addresses written programmes for routine calibration, inspection or checks of automatic, mechanical and electronic equipment, while §211.160(b)(4) requires calibration at suitable intervals for laboratory instruments and recording devices. These provisions apply in their United States regulatory context; they do not replace the applicable EU GMP protocol. (21 CFR 211.63; 21 CFR 211.67; 21 CFR 211.68(a); 21 CFR 211.160(b)(4).)

For any batch-associated qualification records, retain them at least one year after expiry of the respective batch under 21 CFR 211.180(a). Under EU GMP Chapter 4, batch documentation is retained for one year after expiry or at least five years after Qualified Person certification, whichever is longer. Other equipment records follow the applicable approved retention schedule. (21 CFR 211.180(a), current eCFR; EudraLex Volume 4, Part I, Chapter 4, §4.11 (January 2011).)

Frequently asked questions

Is an IQ the same as OQ or PQ?

No. IQ documents installation against the approved design and supplier recommendations. OQ checks whether the installed system performs as intended across anticipated operating conditions. PQ follows successful IQ and OQ to verify performance in the intended process. (EudraLex Volume 4, Annex 15 (2015), §§3.8–3.14.)

Does Annex 15 prescribe one IQ checklist for all equipment?

No. It gives examples of checks and states that the list is not exhaustive. The protocol should be tailored to the facilities, equipment or system and the approved design. (EudraLex Volume 4, Annex 15 (2015), §§3.8–3.9.)

When should a relocation trigger a new IQ?

Assess the relocation under the site’s change-control and qualification process. Annex 15 expressly addresses new or modified facilities, systems and equipment; it does not provide a universal relocation rule for every equipment item.

See also

References

  • European Commission. EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15, “Qualification and Validation” (2015 revision; in operation since 1 October 2015), especially §§2.2, 2.4, 2.7–2.10 and 3.8–3.14. Current Volume 4 index; official Annex 15 PDF.
  • United States. 21 CFR Part 211, current eCFR as accessed 19 October 2026: §§211.63, 211.67, 211.68(a), 211.160(b)(4) and 211.180(a). §211.63, §211.67, §211.68, §211.160, §211.180.
  • European Commission. EudraLex Volume 4, Part I, Chapter 4, “Documentation” (January 2011), §4.11. Official European Commission PDF.

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