ADE/PDE, OEL & Cleaning Validation
Cleaning validation protocol development and support
A sound strategy still has to be executed and documented. We prepare cleaning validation protocols and reports that connect each acceptance criterion to its scientific basis, and support your team when results raise questions.
- Typical documents Protocols, sampling plans, reports, change-control assessments
- Typical inputs Strategy or limits, equipment drawings, analytical methods
- You receive Ready-to-approve documents in your format
Overview
About Cleaning Validation Protocols
Protocols must state what is being demonstrated, where and how samples are taken, which acceptance criteria apply and why. Reports must show that the criteria were met — or explain and resolve why not. Gaps in this chain are a frequent source of inspection observations.
We work with your validation team to produce protocols and reports in your document system format, using health-based limits from your strategy or our PDE/ADE reports.
Use cases
When this service helps
New equipment or a new product
Validation protocols for the first cleaning studies.
Results outside expectations
Support with investigation, rationale and corrective actions.
Changes to cleaning procedures
Change-control impact assessments and verification protocols.
Backlog of reports
Help to compile and close outstanding studies before an inspection.
Scope
What the service covers
- Protocol preparation: objectives, scope, rationale and acceptance criteria
- Sampling plans: worst-case and hard-to-clean locations, swab and rinse methods
- Recovery-study expectations and use of recovery factors
- Visual inspection criteria and documentation
- Report writing, data review and conclusions
- Deviation and out-of-limit investigation support
- Change-control impact assessments and re-validation triggers
Who does what
Your site executes the cleaning, sampling and testing and owns document approval. Globaxa prepares and reviews the documentation.
Why do recovery studies matter?
Swab and rinse methods rarely recover 100% of a residue. Recovery studies establish how much is recovered from each surface material, so results can be corrected and limits applied accurately.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Agree the basisLimits, worst case and equipment scope are confirmed against the strategy.
- Draft the protocolWe prepare the protocol and sampling plan in your template.
- Review resultsData from execution are reviewed against the acceptance criteria.
- Report and closeWe draft the report and help resolve deviations.
Deliverables
What you receive
Validation protocols
Complete protocols with justified acceptance criteria and sampling plans.
Validation reports
Reports summarising results, deviations and conclusions.
Investigation support
Documented rationale and risk assessment for unexpected results.
Technical basis
Guidelines we work to
- EU GMP Annex 15 (2015)Sets expectations for validation protocols, acceptance criteria and reporting.
- PIC/S and WHO guidanceInspectorate guidance on cleaning validation documentation and HBEL-based limits.
- 21 CFR 211.67 (USA)Requires written cleaning procedures for equipment and utensils.
What we need from you
- Cleaning validation strategy or limits (or our PDE/ADE reports)
- Equipment drawings or photographs showing hard-to-clean areas
- Cleaning procedures and analytical method validation summaries
- Your protocol and report templates
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Documentation expectations are broadly consistent across EU, PIC/S, WHO and US inspectorates. We align terminology and format with the authority most relevant to your site.
FAQs
Cleaning Validation Protocols: frequently asked questions
Can you use our templates?
Yes. We prepare documents in your templates and numbering conventions.
Do you visit the site?
Most work is done remotely. Site visits for equipment walk-downs can be arranged where they add value.
Can you help with failed results?
Yes. We support the investigation, assess the patient-safety impact using the HBEL, and help define corrective actions.
Talk to us about Cleaning Validation Protocols
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST