How do manufacturers validate their manufacturing processes in a GMP-compliant way through IQ, OQ and PQ?
We guide pharma, biotech and medtech manufacturers through the complete process validation, from the risk-based validation strategy through Installation, Operational and Performance Qualification to the finalized validation report and ongoing process verification. The critical fork is rarely the qualification itself, but the sequence: companies that define the critical process parameters and acceptance criteria before the PQ, instead of deriving them from the batch data, avoid the repeat runs that extend a validation project by months.
- Pharma
- Biotech
- MedTech
- IVD
Overview
What requirements do GMP and medtech regulations place on process validation?
Validation of critical manufacturing processes through IQ/OQ/PQ and CPV · EU-GMP, ICH Q7, ISO 13485:2016
Last updated: 2026-06-13
Process validation is the documented evidence that a manufacturing process reproducibly delivers a product that meets predefined specifications and quality attributes. It is not an optional extra, but a regulatory obligation. The levers where validation projects most often get stuck:
- The EU-GMP Guide, Annex 15 requires a documented, risk-based validation approach with qualification of facilities and equipment (IQ/OQ/PQ) and validation of the manufacturing process itself; the critical process parameters and acceptance criteria must be defined in advance.
- For active pharmaceutical ingredients, ICH Q7 specifies the validation requirements along the manufacturing process; quality risk management per ICH Q9 governs the scope and depth of validation.
- ISO 13485:2016 requires the validation of processes whose output cannot be fully verified by subsequent monitoring or end-of-line inspection, with defined acceptance criteria, methods and records.
- The FDA process validation model (2011) structures validation into three stages: Process Design, Process Qualification and Continued Process Verification. Validation therefore does not end with a successful PQ, but becomes the ongoing demonstration of process control.
Services
How we support you
Validation strategy & master plan
Risk-based determination of which processes are critical and what depth of validation they require, documented in a validation master plan (VMP) for the production environment per EU-GMP, Annex 15 and ICH Q9.
Learn more →IQ, OQ and PQ: complete execution
Preparation and execution of the protocols for Installation Qualification (correct installation), Operational Qualification (function under defined conditions) and Performance Qualification (consistency under production conditions), including the associated qualification reports.
Continued Process Verification (CPV)
Establishment of a CPV program following the FDA process validation model and ICH Q10, with statistical process control (SPC), trending of critical parameters and an annual report demonstrating sustained process control after the PQ.
Learn more →Revalidation & impact assessment
Assessment of process changes for their effect on the validated status, with determination of the required scope of revalidation, plus gap analysis of outdated validation packages with a prioritized remediation plan.
Sterile processes & cleanroom qualification
Validation of sterile manufacturing processes as a special case, aligned with the requirements for aseptic procedures and environmental conditions per EU-GMP, Annex 15.
Learn more →How we work together
What it comes down to
Process validation rarely fails at a single stage, but rather at their sequence. The EU-GMP Guide, Annex 15 and the FDA model require that the critical process parameters and acceptance criteria be defined before qualification begins. Companies that instead derive them from the measured values of the PQ batches invert the logic: the evidence turns into an after-the-fact description of what the process did anyway. This very inversion is the most common reason why PQ runs have to be repeated and inspectors question the validated status. IQ and OQ are the precondition for the PQ, because a Performance Qualification on non-qualified equipment carries no robust evidence.
The second bottleneck lies after a successful PQ. With the FDA process validation model and ICH Q10, validation does not end with the validation report, but transitions into Continued Process Verification. Without ongoing statistical process control, a process drift remains invisible until it surfaces as an OOS result or a batch failure, and by then the correction is expensive. And every later process change meets the same mechanism: without an impact assessment in change management, it remains open which scope of revalidation is triggered, and a validation backlog grows that becomes visible in the next audit. We therefore front-load the effort, into strategy, parameters and acceptance criteria, where corrections are cheap, instead of into the repeated PQ, where they push out the project.
Our approach
Our approach
Step
Result
Validation strategy & risk assessment
Validation master plan with risk-based prioritization of the critical processes and a defined depth of validation per ICH Q9.
Definition of critical parameters & acceptance criteria
Documented critical process parameters and quality attributes with predefined acceptance criteria, set before the start of qualification.
IQ & OQ
Qualified installation and function of the equipment under defined conditions, fully protocoled and reported.
PQ / Performance Qualification
Demonstration of reproducible process performance across consecutive batches with a scientifically justified sample size.
Validation report
Finalized process validation report with an assessment of deviations and a release recommendation.
Continued Process Verification
Ongoing CPV monitoring with SPC and trending that flags drifts early and maintains the validated status.
Common pitfalls
Where projects commonly fail
Acceptance criteria are only derived from the PQ batch data instead of being defined in advance.
Annex 15 and the FDA model require predefined criteria; anyone who adjusts them after the fact to match the measured values loses the evidentiary character of the validation and invites inspection findings.
The number of PQ batches is set to three without justification.
There is no mandatory minimum number; the scope must be statistically sufficient and scientifically justified. FDA and EMA inspectors expect a rationale derived from process risk and variability, not a rule of thumb.
Continued Process Verification is treated as a closing document instead of an ongoing program.
Per the FDA process validation model and ICH Q10, CPV is the continuous demonstration of process control; without SPC and trending, the early warning for process drifts is missing.
Process changes proceed without an impact assessment of the validated status.
Without a link to change management, it remains unclear which change triggers which scope of revalidation, and a validation backlog builds up that surfaces in the audit.
PQ terminology is conflated with the FDA stage.
PQ is the GMP/ISO term for the third qualification stage; PPQ (Process Performance Qualification) is the FDA-specific term from the 2011 guidance. Using both imprecisely creates gaps in the protocol and report.
FAQ
Frequently asked questions
Sources
- EU-GMP Guide, Annex 15 (Qualification and Validation), primary text
- ICH Q7, Q8, Q9, Q10 (ICH guidelines)
- FDA Guidance for Industry: Process Validation, General Principles and Practices (2011)
- ISO 13485:2016 (Quality management systems for medical devices)
- Writer material on process validation (Entourage, 2026-03-30)
- https://theentourage.de/quality-management-operational-excellence/prozessvalidierung/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU-GMP Guide, Annex 15 (Qualification and Validation)
- ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients)
- ICH Q8 (Pharmaceutical Development)
- ICH Q9 (Quality Risk Management)
- ICH Q10 (Pharmaceutical Quality System)
- FDA Guidance for Industry: Process Validation, General Principles and Practices (2011)
- ISO 13485:2016 (QM system for medical devices)
Related topics
Good Manufacturing Practice (GMP) →
The overarching GMP framework within which process validation sits
Computer System Validation (CSV) →
Validation of GxP-relevant IT systems as a distinct form of validation
Annex 1 (Sterile Manufacturing) →
Validation of sterile manufacturing processes as a special case
Change Management →
Governs the impact assessment and the need for revalidation when processes change
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