Water can be an ingredient, excipient, cleaning medium and source of deviations
In pharmaceutical and cosmetics plants, water moves through intake, pretreatment, reverse osmosis, storage, loops, points of use, formulation, cleaning and rinsing. A microbiological deviation is not just a laboratory result: it can affect batches, equipment release, investigation time and audits.
- Water as critical material: Water may be part of the formula, act as an excipient or support operations where microbiological quality affects the usage decision.
- Loops and points of use: Tanks, recirculation, valves, hoses, filters and low-flow areas can create variability, biofilm or out-of-control trends.
- Cleaning and rinsing: Cleaning water, final rinse water and equipment preparation must be linked to the equipment, cycle, next batch and release evidence.
- Audits and deviations: Quality teams need to show which point was controlled, which criterion applied, what result was obtained and what action was taken.
From water type to quality decision
A digital workflow connects the physical point with the batch, method, result, review and documented action.
- Classify water: Define incoming water, purified water, WFI, process water, cosmetic ingredient water, cleaning, rinsing or special use.
- Map points: Register intake, pretreatment, RO, tank, loop, point of use, line, equipment, room and formulation.
- Assign plan: Configure frequency, method, volume, criterion, owner, laboratory, holding time and result priority.
- Take sample: Record operator, date, time, batch, shift, location, photos, observations and chain of custody.
- Review result: Integrate reading, CoA, trend, indicator, method, QA/QC review and comparison with defined criteria.
- Close decision: Release, hold, resample, investigate, sanitise, open CAPA or close deviation with auditable evidence.
One shared system for quality, laboratory, production and engineering
AquaVerify centralises water history so each team can act without losing technical context or documentary traceability.
- Quality Assurance: Reviews results, trends, deviations, CAPA, CoA and evidence before releasing water, equipment or batch.
- QC microbiology: Manages samples, methods, controls, observations, results and communication with internal or external laboratories.
- Production and manufacturing: Links water, shift, equipment, line, batch, formulation and operational decision before the process continues.
- Engineering and utilities: Controls pretreatment, RO, tanks, loops, sanitisation, points of use, maintenance and configuration changes.
- Regulatory, QP and Responsible Person: Prepares consistent records for dossiers, inspections, customer audits, cosmetic PIF or batch review.
Risk, decision and expected evidence matrix
Each water type requires different evidence. AquaVerify helps connect the point, method, result and decision in one history.
- Purified water loop: Biofilm, microbiological trend, point-of-use variability, downtime or incomplete sanitisation. | Point control: Loop, point, date, operator, method, result, CoA, trend and documented action history. | QA/QC decision: Release, alert, resample, investigation, sanitisation or deviation closure.
- WFI and critical areas: Higher traceability and review requirements, coordinated with the broader contamination control plan. | Integrated evidence: Critical point, batch, room, shift, method, quality review and link to GMP documentation. | Audit support: Data ready for inspection, periodic review, investigation or technical justification.
- Water as cosmetic ingredient: Direct impact on formula, microbiological stability, batch, product safety and release. | Formula traceability: Relationship between water, manufacturing batch, product, tank, result, criterion and CoA. | PIF and quality: Consistent records for product information file, technical owner, customer or audit.
- Final equipment rinse: Risk of microbiological carryover to the next batch or line, especially for water-rich products. | Equipment record: Equipment, cycle, previous batch, next batch, sample, result, review and release status. | Documented closure: Cleaning evidence, investigation, repeat, hold or equipment release.
- Incoming water and pretreatment: Changes in microbiological load, source, filters, RO, storage, maintenance or supply incidents. | System trend: Monitoring of intake, treatment stage, date, point, result and possible cause of variation. | Technical action: Maintenance, filter change, sanitisation, frequency adjustment or source investigation.
Technology and reporting for a traceable water programme
Modules can be combined according to matrix, method, laboratory, water type, internal limits and quality-system criteria.
- AquaVerify Cloud: Points, users, batches, equipment, results, CoA, trends, deviations, actions and evidence in a central environment.
- AquaVerify App: Sampling record with location, time, owner, photos, observations, QR, batch, shift and chain of custody.
- AquaVerify CoA: CoA reports linked to sample, method, laboratory, criterion, review and release status.
- ENUMERA® Soma 100 mL: Enumeration of somatic coliphages in 100 mL when advanced viral-indicator verification is required.
- PLAQUE Soma 1 mL and 100 mL: Plate enumeration options for laboratories working with ISO 10705-2, SAL/DAL or equivalent programmes.
- Ready-to-use MSA/MSB: Prepared media and components to standardise laboratory flow and reduce operational variability.
- Deviation management: Alerts, review, investigation, resampling, sanitisation, CAPA and documentary closure by point or batch.
- Multi-site dashboard: Consolidated view by site, water system, product, customer, laboratory, trend and criticality.
Control programmes for pharmaceutical, cosmetics and personal care manufacturing
The configuration adapts to risk level, product type, water grade, quality system, laboratory and in-house or outsourced manufacturing model.
- Purified water: Follow-up by tank, loop, point of use, trend, method, affected batch and release evidence.
- WFI and sterile manufacturing: Documentation support for critical points, quality review and evidence integrated with the wider analytical plan.
- Non-sterile medicines: Control of water used in solutions, suspensions, semi-solids, creams, gels, syrups or topical products.
- Cosmetics and dermocosmetics: Traceability of water as an ingredient in emulsions, gels, shampoos, toners, creams, serums and personal care products.
- Cleaning, CIP/SIP and rinsing: Link final rinse, cycle, equipment, line, previous batch and next batch with results and decision.
- Pretreatment and utilities: Monitor incoming water, filters, RO, UV, tanks, recirculation, sanitisation and low-flow points.
- CDMO, CMO and private label: Standardise evidence by customer, product, manufacturing order, batch, site and external laboratory.
- Deviation investigation: Compare points, dates, batches, equipment, results and trends to prioritise resampling, sanitisation or likely cause.
Compatible with quality, GMP and microbiological control programmes
AquaVerify does not replace the quality system or laboratory validation. It strengthens traceability, review and documentary evidence for the water-control programme.
- EMA · Water for pharmaceutical use: Support to organise evidence by water type, use, method, point, result and quality review.
- EudraLex Volume 4 GMP: Documentary workflows alignable with quality control, documentation, computerised systems, validation and release.
- European Pharmacopoeia: Use of references such as purified water, WFI and TOC within the analytical plan defined by the organisation.
- EU Cosmetics Regulation 1223/2009: Support for safety records, product information files, manufacturing traceability and Responsible Person evidence.
- EN ISO 22716: Cosmetic good manufacturing practice for production, control, storage and shipment.
- ISO 21149 and ISO 16212: Cosmetic microbiology references for aerobic mesophilic bacteria, yeast and mould when applicable to product or plan.
From isolated critical points to multi-site water control
The programme can start with one loop, one line or one product type and progressively expand into a global model.
- Critical inventory: Classify water types, points, equipment, lines, products, laboratories and owners.
- Sampling plan: Define frequency, method, volume, criteria, turnaround expectations and review rules.
- Digital custody: Capture samples, context, location, batch, observations, photos and chain of custody.
- Reporting and trends: Issue CoA, review alerts, analyse trends and connect results with decisions.
- Deviations and scale: Standardise investigation, CAPA, audit, multi-site deployment, customers and periodic review.
An implementation focused on evidence, adoption and operational continuity
AquaVerify is configured to work alongside internal laboratories, external laboratories, LIMS, ERP, quality procedures and outsourced manufacturing models.
- Point assessment: Selection of critical points, products, water grades, equipment, owners and existing documentation.
- Workflow setup: Users, roles, criteria, forms, samples, CoA, alerts, deviations and actions.
- Operational pilot: Workflow validation on one line, loop, site, laboratory or product category before expansion.
- Controlled scale-up: Extension to more sites, customers, products, laboratories and monitoring dashboards.
FAQ
Does AquaVerify replace the GMP system or accredited laboratory?
No. AquaVerify organises sampling, traceability, results, CoA, trends and deviations. The quality system, method validation, limits and laboratory scope remain the responsibility of the organisation and its qualified providers.
Can it be used for purified water and WFI?
Yes, as a traceability, evidence and review layer for the points and methods defined by the quality programme. Water grade, limits and applicable tests must be defined according to use, pharmacopoeia, dossier and quality system.
Is it suitable for cosmetics and personal care manufacturing?
Yes. It links ingredient water, process water, cleaning, rinsing, batch, formula, tank, line, result, CoA and records for quality teams, customers, PIF or audits.
Where do somatic coliphages fit?
Somatic coliphages can be used as viral indicators in specific water plans, advanced verification, contamination investigation or matrices where the customer, laboratory or technical criterion requires them.
Can it work with external laboratories?
Yes. The platform can record chain of custody, receipt, method, result, observations, CoA and review, maintaining traceability between site, laboratory and quality team.
How does it help during a deviation?
It allows comparison of history, point, batch, equipment, operator, method, trend and previous actions to decide resampling, investigation, sanitisation, hold, release or CAPA with traceable evidence.
