Documentation of Compounding Activities and Quality Assurance

NAPRA Model Standards

Non-sterile compounding governed by ___________…

Documentation

___________ ensures traceability, quality control, regulatory compliance…

Records

________ support patient safety, consistent practices, inspection readiness…

Master Formulation Record (MFR)

Key elements in __________ include:

Name, strength, dosage form

Active/inactive ingredients with quantities, compatibility, storage

Calculations for ingredient amounts

Step-by-step compounding instructions (order, lime/endpoints)

Required equipment and PPE precautions

Beyond-Use Date (BUD), packaging, storage requirements

Quality control measures (expected yield, final product description)

Reference sources and creation/update dates

Sample label format

Maintenance: keep MFRs up-to-date, document rationale for changes

Storage: hard-copy binder or electronic system

Master recipe

“__________" for each compounded preparation…

Compounding Record

Real-time documentation for each batch or individual preparation

Must include:

Product name, strength, dosage form

Production date, total quantity, batch/prescription number

Ingredients with lot numbers and expiry dates

Personnel names (preparer and verifier)

Reference MFR and note any deviations

Final QC resuils (appearance, weight, pH)

Assigned BUD

Patient or prescription number (if patient-specific)

Documentation of issues or incidents

Master Formulation Record

Purpose: Master recipe

Creation Timing: In advance

Patient information included? Only if patient-specific

Signatures: Not required

Lot tracking? No

Quality control results: QC plan only

Compounding Record

Purpose: Real-time batch documentation

Creation Timing: During/after compounding

Patient information included? Yes, when applicable

Signatures: Yes

Lot tracking? Yes

Quality control results: Actual batch results

Cleaning, Maintenance, Calibration & Environmental monitoring

Key aspects of Quality Assurance & Control Documentation: Document Everything!! Essential documentation includes cleaning and maintenance logs for facilities and equipment. Calibration records for balances and measuring devices are also required. Environmental monitoring records are necessary, as dictated by the risk level….

Quality Assurance (QA)

___________: in a compounding pharmacy involves planned and systematic activities to ensure quality and safety in formulation and adaptation processes. Key aspects include:

Documentation: Encompasses records for procedures, training, equipment, and changes.

Adherence to Standards: Verified through internal and external audits.

Validation: Protocols for new technologies or techniques.

Examples: SOPs, training records, calibration logs, change control records, audit reports, and validation protocols….

Quality Control (QC)

_____________: documentation involves records generated from testing and inspection activities to ensure each batch meets specifications. Key examples of this documentation include:

Master Formulation and Batch Records: Detailing ingredients, quantities, and preparation steps.

In-process testing logs: Recording measurements like pH, viscosity, and particle size analyses.

Certificates of Analysis (CoAs): Verifying the identity and purity of incoming materials.

Final product test results: Covering potency, sterility, microbial limits, and appearance, along with documentation of corrective actions when needed…

NAPRA requirements fir compound records

________________:

Official/assigned name, strength, and dosage form

Reference to the Master Formulation Record

Names and quantities of all ingredients

Sources, numbers, and expiry dates of ingredients

Total quantity compounded; assigned prescription or batch number

Date of preparation and assigned Beyond-Use Date (BUD)

Names of personnel: preparer, QC checker, approver

Results of QC procedures: pH, weight ranges, final volume, yield

Any deviations from Master Formulation Record

Observed problems or adverse reactions

Rationale for compounding (e.e, allergy, shortage, swallowing issues)

Formulation Record

________________:

Blueprint or master recipe

Standardized instructions; not updated with batch-specific data

Reviewed and validated periodically

Compound Record

_______________:

Documents the actual non-sterile compounding events

Includes batch-specific details for each prescription or stock batch

Maintained for every compound prepared

Formulation Record

Purpose: Master recipe

Timing: Created in advance

Patient-specific info: Not included

Staff signatures: Not required

Ingredient lot tracking: Not included

QC results: General Procedures

BUD Assignment: Included as reference

Source Documentation: Literature references

Updates: Periodic review

Compound Record

Purpose: Real-time event documentation

Timing: Created during/after compounding

Patient-specific info: Included when applicable

Staff signatures: Required (preparer, checker, approver)

Ingredient lot tracking: Required

QC results: Batch-specific outcomes

BUD Assignment: Applied to specific batch

Source Documentation: Rationale for compounding if needed

Updates: New record for each batch

Policies & Procedures

Written policies must exist and be readily retrievable

Cover cleaning, risk assessment, handling hazardous substances

Provide standardized guidance for all compounding activities…

Personnel training records

Document initial and ongoing competency assessments

Record training topics, dates, trainee and assessor names

Track continuing education, new procedures, remedial training…

Incident & Adverse Event Reports

Capture errors, procedural deviations. contamination events, adverse reactions

Include event description, date, personnel involved, immediate actions

Document root cause analysis and corrective…

Risk Assessment

Mandatory for every non-sterile preparation

Evaluate risks to product (stability, contamination) and personnel (exposure)

Review at least annually or when changes accur

Document findings, decisions, and reference sources (SDS, MFRs, literature)…

Retention Period & Summary

Retain all compounding documentation for minimum two years (or as per provincial regulations)

Accurate, up-to-date, retrievable records demonstrate quality and compliance

Proper documentation safeguards patient safety and streamlines error investigations…

Update as needed

How does your pharmacy manage MFR updates?

Doesn’t print, incorrect info

Have you encountered challenges with electronic compounding records?

Keep documents for years

What steps can we take to improve incident reporting?