20 Chapter 20: Final Inspection on Compounded Preparations

Final verification is the last step in the compounding process before the product is dispensed. It ensures that the compounded preparation meets all quality, safety, and documentation requirements and is suitable for patient use. According to NAPRA, this step must be conducted by a pharmacist (or pharmacy technician under supervision, where permitted) and must be documented.

Purpose

• Confirm that the final product was compounded correctly and safely.

• Detect and correct errors before the product reaches the patient.

• Ensure compliance with the Master Formulation Record (MFR), Compounding Record (CR), and regulatory standards.

Components of Final Verification

1. Verification Against Documentation

   •  Prescription – verify to the computer software generated transaction label.  This is done in a similar manner as all prescriptions.
     • Right patient
     • Right drug
     • Right strength
     • Right dosage form
     • Right directions
     • Right quantity/refills
     • Right prescriber
     • A clinical check needs to be done by the pharmacist to ensure this is a clinically appropriate preparation for the patient.

   • Master Formulation Record (MFR):

     • Ensure the final product matches the intended formula.

     • All ingredients, quantities, and steps should be adhered to precisely.

   • Compounding Record (CR):

     • Check that all procedural steps were documented in real time.

     • Verify the initials of personnel, lot numbers, quantities, and expiry dates of ingredients.

2. Ingredient and Quantity Confirmation

   • Reconfirm that the correct ingredients and correct quantities were used.

   • Check weighing and measuring logs against target values.

3. Physical Assessment of Final Product – this step must include looking at the product

   • Physical characteristics:

     • Colour
     • Smell
     • Quality (no streaks, lumps, contaminants)
     • Quantity
     • Packaging
     • Label (including auxiliary labels)
     • Pharmaceutical elegance
     • Compare with previous batches (if applicable) or documented expectations.

   • Uniformity:

     • Ensure even mixing (no separation, sedimentation, or stratification unless expected).

   • Final weight or volume:

     • Confirm the total quantity is within an acceptable range (±10% unless otherwise specified).

4. Labeling and Packaging Verification

   • Verify:

     • Correct product name and strength.

     • Dosage form.

     • Patient name (if applicable).

     • Beyond-use date (BUD) based on NAPRA stability guidance.

     • Storage conditions (e.g., “Refrigerate,” “Keep tightly closed”).

     • Auxiliary labels (e.g., “Shake well,” “For external use only”).

     • Pharmacy information and any legal requirements.

5. Container-Closure System

   • Ensure the product is dispensed in a container that:

     • Is appropriate for the formulation (e.g., light-resistant, child-resistant, moisture-barrier).

     • Will not interact with or degrade the compound.

     • Is clean, intact, and appropriately labeled.

6. Final Sign-Off and Documentation

   • The pharmacist or pharmacy technician conducting the final check must:

     • Review and sign off the Compounding Record.

     • Confirm all verification steps were completed.

     • Document any deviations and corrective actions taken.

You also need to know and check dosage form specific QA/QC information.  For example:

1. Solutions

Quality Control (QC)

• Ensure complete solubilization—no visible particles or precipitation.
• Check for color change, odor, or microbial contamination.
• Confirm volume and container integrity.
• Measure and document pH (important for stability and compatibility).

Quality Assurance (QA)

• Use purified water and compatible solvents.
• Validate mixing times and equipment.
• Follow SOPs for preparation, filtering (if needed), and container selection.
• Use appropriate BUD based on aqueous formulation guidance (USP <795> / NAPRA).

2. Suspensions

Quality Control (QC)

• Confirm even dispersion of particles (no caking or layering).
• Shake test: ensure product resuspends uniformly.
• Visual inspection for color, odor, and particulate matter.
• Measure pH for stability if applicable.

Quality Assurance (QA)

• Use appropriate suspending agents and validated mixing methods.
• Maintain particle size consistency by sieving or milling.
• Calibrate all measuring devices.
• Apply BUDs based on water content and risk of microbial growth.

3. Emulsions

Quality Control (QC)

• Check for phase separation (creaming, cracking).
• Evaluate color, consistency, and homogeneity.
• pH measurement (especially for external emulsions).
• Observe for signs of rancidity or instability.

Quality Assurance (QA)

• Use accurate ratios of emulsifiers to oil/water phase.
• Validate emulsification technique (e.g., high-shear mixing).
• Ensure container compatibility and appropriate labeling (e.g., “shake well”).
• Store under recommended conditions (temperature-sensitive).

4. Syrups

Quality Control (QC)

• Check clarity, viscosity, and sweetness uniformity.
• Inspect for microbial growth or crystallization.
• pH and specific gravity (if needed for certain formulations).

Quality Assurance (QA)

• Use high-quality sucrose or non-sugar base with preservatives (if required).
• Validate heating/cooling process (if used).
• Ensure airtight containers to prevent moisture loss.
• Assign BUDs based on preservative use and water activity.

5. Creams

Quality Control (QC)

• Evaluate appearance: smooth, homogenous, no grittiness or separation.
• Check spreadability and color.
• Confirm pH and stability over time.

Quality Assurance (QA)

• Use validated mixing technique (e.g., geometric dilution).
• Maintain consistency with base preparation or commercial base standards.
• Prevent microbial contamination by using clean equipment and surfaces.
• Store in well-sealed, labeled containers under suitable conditions.

6. Ointments

Quality Control (QC)

• Uniform texture and color.
• Free from foreign particles and phase separation.
• Assess melting point (if applicable) and spreadability.

Quality Assurance (QA)

• Use appropriate levigation and incorporation techniques.
• Ensure even distribution of active ingredients.
• Maintain cleanliness to avoid contamination.
• Label with specific instructions (e.g., external use only, area of application)

7. Lotions

Quality Control (QC)

• Visual check for separation or sedimentation.
• Assess uniformity and ease of application.
• pH and viscosity testing as needed.

Quality Assurance (QA)

• Stabilize emulsion using appropriate emulsifiers and homogenization.
• Store in shake-before-use containers if separation risk exists.
• Clean compounding area and equipment between batches to prevent residue.

8. Pastes

Quality Control (QC)

• Evaluate consistency, thickness, and homogeneity.
• Check for grittiness or particle aggregation.
• Confirm absence of microbial contamination (if applicable).

Quality Assurance (QA)

• Use validated incorporation techniques for insoluble powders.
• Ensure ingredients are evenly distributed and base is stable.
• Store in wide-mouth containers for easier dispensing.
• Label with external use instructions and application directions.

9. Capsules

Quality Control (QC)

• Check weight uniformity (sample at least 10 capsules).
• Inspect for cracks, empty shells, or powder leakage.
• Ensure correct capsule size and color coding (if used).

Quality Assurance (QA)

• Standardize blending techniques (e.g., geometric dilution, tumbling).
• Verify capsule-filling machine calibration or manual fill weights.
• Clean all equipment thoroughly between preparations.
• Store in labeled, moisture-resistant containers

10. Suppositories

Quality Control (QC)

• Visual inspection for:
  • Uniform appearance, shape, and color.
  • Absence of air bubbles, cracks, or separation of phases.
• Weight uniformity: Random sampling of individual suppositories.
• Melting point and disintegration: Should melt or dissolve at body temperature.
• Texture and hardness: Evaluate for brittleness or stickiness.
• Packaging integrity: Ensure proper sealing of molds or containers.

Quality Assurance (QA)

• Use accurate displacement value calculations to adjust for API volume.
• Validate mold calibration and filling method for consistency.
• Maintain appropriate melting/cooling temperatures to avoid layering or cracking.
• Use clean, dry molds and store under recommended conditions (often refrigerated).
• Label with route of administration, storage conditions, and “For Rectal/Vaginal Use Only” warnings.
• Document base type, mold type, and batch records for traceability