Performance Qualification (PQ) Protocol and Report Format

In short: Performance qualification (PQ) is the last qualification stage for equipment, utilities and systems. It shows, with documented evidence, that the item performs effectively and reproducibly in real use. This page explains what regulators expect and gives an example protocol and report format that you must adapt to your own quality system.

What is performance qualification?

EU GMP Annex 15 (Qualification and Validation, 2015) defines PQ as the documented verification that systems and equipment can perform effectively and reproducibly, based on the approved process method and product specification. PQ normally follows successful installation qualification (IQ) and operational qualification (OQ). In some cases it may be appropriate to run PQ together with OQ or with process validation (Annex 15, section 3.13).

Annex 15, section 3.14, says PQ should include, but is not limited to:

• tests using production materials, qualified substitutes or simulated product that behaves equivalently under normal operating conditions, at worst-case batch sizes, with the sampling frequency used to confirm control justified; and
• tests covering the operating range of the intended process, unless development data already document the operating ranges.

Annex 15 does not fix a number of runs or days for PQ. You decide, justify and write down the extent of testing in the protocol, based on risk and process knowledge.

See also: Installation Qualification (IQ) protocol and report, Operational Qualification (OQ) protocol and report and Qualification stages for equipment, facilities, utilities and systems.

What the protocol and report must achieve

Annex 15, section 2, sets the documentation expectations that apply to PQ as to any other validation work:

• The protocol defines the critical systems, attributes and parameters and the associated acceptance criteria (2.4).
• All qualification documents are approved by the personnel defined in the pharmaceutical quality system (2.2).
• A significant change to the approved protocol during execution, such as to acceptance criteria or operating parameters, is documented as a deviation and scientifically justified (2.7).
• A result that fails a pre-defined acceptance criterion is recorded as a deviation and investigated under local procedures; its implications are discussed in the report (2.8).
• The report summarises the results against the acceptance criteria, justifies any later change to those criteria, and ends with a final recommendation on the outcome (2.9).
• Release to the next stage is formally authorised, and conditional approval is possible only where there is a documented assessment of no significant impact (2.10).

Example PQ protocol format

This is an illustrative template. Replace the bracketed items and the example criteria with those from your own approved validation master plan and risk assessment. See also Validation Master Plan.

Header and approval

1. Objective

To demonstrate that the [equipment or system] performs as intended and consistently meets its predetermined specifications when run on its intended schedule under normal conditions and, where appropriate, under worst-case conditions, with all relevant data recorded.

2. Scope

PQ is carried out after IQ and OQ are complete and approved. It is repeated or partly repeated after installation, relocation or a change assessed as needing requalification, and at intervals justified in the validation master plan (Annex 15 section 4 expects equipment and systems to be re-evaluated at an appropriate frequency).

Example in-house practice: where one system supplies another during qualification, the supplying system is qualified first. An example is a purified water system before a pure steam generator, and the steam generator before an autoclave that uses it.

3. Responsibilities

4. Materials, equipment and documents

List and attach copies of:

• the SOPs for normal operation of the system under test, including data record forms, charts, diagrams, and materials and equipment needed; and
• the SOPs specific to the performance tests, including data forms, calculations, statistical analyses, and the predetermined specifications and acceptance criteria.

5. Procedure (example in-house criteria)

These run counts and the 20-day period are example in-house criteria, not regulatory requirements. Justify your own choice (for example using risk, variability and process knowledge) in the protocol.

6. Evaluation

1. Attach all completed, signed data record forms.
2. Complete the summary data record (Chart 1).
3. Perform all required calculations and statistical analyses (Chart 2).
4. Compare results with the acceptance criteria (Chart 3).
5. Write a deviation report with justification and impact assessment.
6. Write the PQ report.
7. Submit the full PQ package to QA for review and approval.

Chart 1: summary data record

Prepare this for the specific procedure under test. Include performed by / date and verified by / date lines.

Chart 2: calculations and statistical analyses

Record each calculation, the method used, the result, and performed by / verified by lines with dates.

Chart 3: acceptance criteria against results

Deviation report

Example PQ report content

The PQ report should include:

• date the study started and date it finished;
• observations made and problems encountered;
• completeness of the information collected;
• a summary of the deviation report;
• results of every test and whether each met its acceptance criterion;
• location of the original data;
• any other relevant information; and
• a conclusion on whether the equipment or system is qualified, with a recommendation on release for use.

The report is written and verified by named persons with dates, then approved by Quality Assurance.

Record retention

Keep the signed protocol, raw data and report under your document control system. Where qualification data support the release of batches, retain them for at least 1 year after the expiry date of the respective product batch (EU GMP Part I Chapter 4 section 4.11, or 5 years after QP certification if longer; also 21 CFR 211.180(a)), and longer if local law or the marketing authorisation requires.

Frequently asked questions

Is PQ always done after OQ?

Normally yes. Annex 15 says PQ should normally follow IQ and OQ, but allows it to be performed together with OQ or process validation when that is justified.

How many runs does PQ need?

No regulation gives one number. The protocol must justify the number and duration, based on risk, process variability and prior knowledge.

Is PQ the same as process validation?

No. PQ shows that equipment or a system performs reproducibly. Process validation shows that the manufacturing process gives product meeting its specification and quality attributes.

Can acceptance criteria be changed during execution?

Only as a documented deviation with scientific justification, as described in Annex 15 section 2.7. Do not adjust criteria after seeing results without that justification.

References

1. European Commission, EudraLex Volume 4, EU GMP Guidelines, Annex 15: Qualification and Validation (2015), sections 2, 3.13, 3.14 and 4, plus the glossary definition of PQ.
2. European Commission, EudraLex Volume 4, Part I, Chapter 4: Documentation (revision effective 30 June 2011), section 4.11.
3. US FDA, 21 CFR 211.180(a), General requirements (records retention).
4. WHO, Quality Assurance of Pharmaceuticals, Volume 2 (as cited by the original article).