PV Processes, areas and equipment
Process Validation Protocols
Capable, in-control processes with statistical backing. A process can be running well and still have no way to prove it. We design statistically sound validation protocols that show your process is capable and in control, and that catch future drifts in time.
Signals
When do you need it?
- You're launching a product or transferring a processA new plant, new equipment, a scale-up or a change of critical supplier.
- There are recurring deviationsAnd it's unclear which parameter is causing them.
- Your current validation is just 3 batchesWith no continued verification or statistical rationale behind it.
- An inspection asked for justificationOf the acceptance criteria and the sampling plan.
Approach
Documentation that supports improvement
Well-executed process validation is also an optimization tool. Once you identify the critical parameters and measure their variability, you know where the margin is and where the risk is.
We cover all three life cycle stages: process design, process performance qualification and continued process verification. Acceptance criteria are justified and the statistical analysis is clear, not a black box.
Catching a drift before it happens saves deviations, investigations and batches.
How we do it
Service stages
- S1DesignCritical process parameters (CPP) and critical quality attributes (CQA).
- S2QualificationPPQ protocol, sampling and acceptance criteria.
- S3Continued verificationAlert and action limits, and trending.
- RPTReportConclusions, process capability and recommendations.
Regulatory framework
What the regulations require, point by point.
These are the references we work with for this service. We apply the ones that fit your market and your type of product.
FDA United States
- Process Validation: General Principles and Practices (2011)Three-stage life cycle approach: design, qualification and continued verification.
- 21 CFR 211.100 and 211.110Written procedures, production control and in-process sampling.
EU GMP EudraLex Volume 4
- Annex 15 (2015)Qualification and validation: traditional, continuous and hybrid validation, and ongoing process verification.
ICH Harmonization
- ICH Q8(R2)Pharmaceutical development and design space.
- ICH Q9(R1)Risk management to define critical parameters.
- ICH Q10Pharmaceutical quality system and continual improvement.
LATAM Local authorities
- ANMAT Disposition 4159/2023GMP: qualification and validation requirements.
- ANVISA RDC 658/2022GMP for medicinal products: process validation.
Deliverables
What you get.
Inspection-ready documentation, fully traceable and in your format. And a team trained to maintain it.
- Analysis of the existing processDocument review, variables and risks per ICH Q9.
- CPP and CQA identificationCritical parameters and attributes with their rationale.
- Validation protocolScope, sampling, methods and acceptance criteria.
- Statistical frameworkTools, process capability, alert and action limits.
- Report templatesFormats that make interpretation and decision-making easier.
- Continued process verification programTrending and periodic review to maintain the validated state.
FAQ
What clients ask before we start
Are three batches still required?
The number of batches must be justified based on risk and process knowledge. Three batches is common practice, not a universal requirement.
Do you perform the statistical analysis?
We design the statistical framework, criteria and tools, and work with your team to interpret the results.
What does continued verification include?
A monitoring plan for parameters and attributes with alert and action limits, plus periodic trend review.
Works well with
Related services
-
C&Q
Qualification, mapping, FAT and SAT
New equipment, cleanrooms, warehouses and cold rooms that need to be qualified.- ISO 14644
- EU GMP Annex 1
- EU GMP Annex 15
-
SOP
SOP development
SOPs written for compliance that nobody reads, understands or follows.- 21 CFR 211.100
- EU GMP Chapter 4
- ICH Q10
-
XLS
Excel spreadsheet validation
Spreadsheets that calculate results, yields or stability and that nobody has validated.- GAMP 5
- 21 CFR Part 11
- EU GMP Annex 11
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.