Ontario non-sterile compounding

Compounding documentation, organized for clear oversight.

Build and maintain a connected documentation system designed to support alignment with NAPRA Model Standards and Ontario College of Pharmacists expectations.

Independent documentation support. Professional review and pharmacy approval remain essential.

Document control

One connected record
Controlled
RA
Risk assessmentRationale, references, mitigation
Reviewed
MF
Master formulationFormula, process, BUD, QC
Approved
CR
Compounding recordTraceability and verification
Per batch
QA
Quality trailDeviations, CAPA, recalls
Ongoing

Designed around

Risk assessmentDocument controlTraceabilityQuality assuranceOntario · Non-sterile

Documentation system

Every controlled document has a place—and a relationship.

Move beyond disconnected Word files and folders. Connect the formula, its risks, the people, the equipment, each preparation, and the quality trail.

01

Formula control

Master Formulation Records, calculations, BUD rationale, references, packaging, storage, and controlled revisions in one connected record.

02

Risk assessment

Document preparation risk, personnel risk, cumulative risk, mitigation measures, supporting references, and scheduled reassessment.

03

Preparation records

Trace ingredients, lots, expiry dates, quantities, stage checks, final verification, release, and linked quality events.

04

People & procedures

Keep SOPs, staff acknowledgements, training, skills assessments, supervisor oversight, and corrective training current.

05

Equipment & environment

Organize cleaning, calibration, maintenance, temperatures, facility checks, and manufacturer-recommended review intervals.

06

Quality assurance

Link deviations, complaints, incidents, recalls, corrective actions, effectiveness checks, and inspection exports.

Standards framework

Built to make expectations visible.

A structured crosswalk helps the pharmacy see what is documented, who approved it, when it must be reviewed, and where the supporting evidence lives.

CompEX is a Saskatchewan implementation resource. Ontario requirements and OCP-adopted standards remain controlling for Ontario practice.

ExpectationDocumentation response
Risk for every preparationAssessment, references, mitigation, assigned level, annual review
Current approved formulaVersion control, technical review, supervisor approval, archived revisions
Ingredient traceabilitySupplier, lot, receipt, expiry, SDS, recall links
Personnel competencyTraining matrix, skills assessment, acknowledgements, corrective actions
Quality assuranceVerification, deviations, CAPA, incidents, audit history

Controlled workflow

From first assessment to an inspection package.

Professional judgment stays with the pharmacy. The system makes that judgment easier to document, approve, retrieve, and maintain.

  1. 01

    Assess

    Review the pharmacy, formula, ingredients, frequency, facilities, and cumulative risk.

  2. 02

    Develop

    Create the risk assessment, MFR, SOPs, forms, logs, and supporting references.

  3. 03

    Review

    Complete technical review with the pharmacy's designated compounding professionals.

  4. 04

    Approve

    Record the authorized version, effective date, signatures, and review schedule.

  5. 05

    Use

    Complete preparation records with traceability, stage checks, and final verification.

  6. 06

    Maintain

    Track reviews, training, equipment, QA events, revisions, and inspection packages.

Professional services

Clear scope. Clear fees. No surprise billing.

Starting prices are shown in Canadian dollars. Every pharmacy receives a written scope and quote before project work begins.

Virtual consultation

$175per hour

Focused guidance for documentation questions, priorities, and next steps.

  • 60-minute private video meeting
  • Paid in full when booked
  • 15-minute introductory call available at no charge
Request this service

Documentation gap review

$750starting price

A structured remote review of the pharmacy's current documentation system.

  • Up to three document-review hours
  • Written priority findings
  • 45-minute findings meeting
Request this service

Documentation support

Customwritten project quote

Defined projects for templates, SOPs, MFR frameworks, remediation, or follow-up.

  • Scope confirmed before work begins
  • Follow-up support at $175 per hour
  • Pharmacy approval remains required
Request this service
Payment

Virtual consultations are prepaid. Review packages and projects require a 50% booking deposit, with the balance due before the final report is released.

Travel

Travel within 30 km is included. Travel from 31–100 km is $150. Longer travel is quoted separately; approved parking, tolls, flights, and accommodation are billed at cost.

Tax & professional boundary

HST is additional where applicable. Services provide documentation support and do not constitute an OCP inspection or guarantee regulatory compliance.

Private portal

See the whole documentation picture without opening ten folders.

One role-based workspace for document status, formula reviews, training, equipment, quality events, and inspection exports.

  • Current approved version at the point of use
  • Review dates and missing-record alerts
  • Full authorship, approval, and audit history
Open portal prototype
Documentation controlGood morning
SP
Active formulas9
Reviews due2
Open QA0
Review queueThis month
Risk assessmentAnnual review due
Jul 28
Equipment calibrationMazerustar mixer
Aug 04
Staff acknowledgementCleaning SOP v3
2 of 3

Start with a gap review

Make the current state clear before creating more documents.

Review existing formulas, records, SOPs, training, equipment logs, and QA documentation against the pharmacy’s actual compounding scope.

Emaildscompoundcanada@gmail.com
Professional boundary

CompoundDocs Canada is an independent documentation-support service. It is not affiliated with, endorsed by, or approved by NAPRA or OCP.

Your submission is processed by FormSubmit and delivered to CompoundDocs Canada by email.