Health Sciences and Social Services Curative Health

Pharmaceutical Product Compounding and Packaging Training

SAQA US 256496 | NQF 3 | Credits 12 | Duration 9 Days
From $1,318 per delegate

Description

This course equips learners with the competencies required to compound, manipulate, prepare, and package pharmaceutical products in accordance with Good Manufacturing Practice (GMP) and relevant legislative requirements. It focuses on the practical skills and theoretical knowledge necessary for safe and effective pharmaceutical compounding, ensuring product quality and patient safety.

Learning Outcomes

  • Apply principles of Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOPs) in compounding and packaging activities.
  • Demonstrate accurate measurement, mixing, and manipulation of pharmaceutical ingredients to produce compounded preparations.
  • Implement appropriate packaging techniques to ensure product stability, sterility, and compliance with regulatory requirements.
  • Evaluate product quality through visual inspection, documentation, and adherence to quality control procedures.
  • Analyze potential risks and hazards in the compounding environment and apply safety measures to prevent contamination and errors.
  • Design a systematic workflow for compounding and packaging that optimizes efficiency and maintains traceability.

Target Audience

This course is designed for pharmacy assistants, pharmacy technicians, and other healthcare support staff involved in the preparation and packaging of pharmaceutical products in retail, hospital, or manufacturing settings.

Prerequisites

None — open enrollment.

Course Outline

Day 1: Introduction to Pharmaceutical Compounding and Regulatory Framework

Objectives:
• Understand the scope and importance of compounding in pharmacy
• Identify key regulatory bodies and legislation governing compounding in South Africa
• Explain the role of SAQA and the HPCSA in setting standards
• Describe the principles of Good Manufacturing Practice (GMP) in compounding

Topics:
• Definition and history of pharmaceutical compounding
• Regulatory framework: Medicines Act, SAQA, HPCSA
• GMP principles: premises, equipment, personnel
• Quality assurance and documentation requirements
• Ethical considerations in compounding

Day 2: Pharmaceutical Raw Materials and Excipients

Objectives:
• Identify different types of raw materials used in compounding
• Understand the properties and functions of excipients
• Evaluate the quality and purity of pharmaceutical ingredients
• Apply principles of stability and compatibility

Topics:
• Active pharmaceutical ingredients (APIs) and excipients
• Sources and specifications of raw materials
• Solubility, pH, and compatibility considerations
• Stability testing and storage conditions
• Handling of hazardous substances

Day 3: Compounding Equipment and Facilities

Objectives:
• Describe the types of equipment used in compounding
• Understand the design and maintenance of compounding facilities
• Apply principles of aseptic technique and cleanroom operations
• Implement equipment calibration and cleaning procedures

Topics:
• Mixing, blending, and homogenization equipment
• Weighing and measuring devices
• Cleanroom classifications and environmental monitoring
• HVAC systems and laminar flow hoods
• Equipment validation and maintenance logs

Day 4: Formulation Development and Calculations

Objectives:
• Perform pharmaceutical calculations for compounding
• Develop formulations based on patient needs
• Adjust concentrations and dosages accurately
• Document formulation records and batch sheets

Topics:
• Pharmaceutical calculations: weight, volume, percentage
• Compounding formulas and master formulation records
• Extemporaneous compounding: creams, ointments, solutions
• Pediatric and geriatric dosing considerations
• Batch size adjustments and yield calculations

Day 5: Sterile Compounding and Aseptic Techniques

Objectives:
• Understand the principles of sterile compounding
• Perform aseptic manipulations in a cleanroom environment
• Prepare sterile products such as IV admixtures and TPN
• Apply sterility testing and quality control measures

Topics:
• Aseptic technique: hand washing, garbing, gloving
• Laminar airflow workstations and isolators
• Preparation of intravenous admixtures
• Total parenteral nutrition (TPN) compounding
• Sterility testing, endotoxin testing, and beyond-use dating

Day 6: Non-Sterile Compounding: Solids, Liquids, and Semisolids

Objectives:
• Prepare non-sterile dosage forms including capsules, suspensions, and ointments
• Select appropriate excipients and vehicles
• Ensure uniformity and stability of compounded preparations
• Perform quality control tests on non-sterile products

Topics:
• Capsule filling techniques (hard and soft gelatin)
• Suspensions and emulsions: formulation and preparation
• Ointments, creams, and gels: bases and compounding
• Suppositories and lozenges
• Quality control: uniformity, pH, viscosity, microbial limits

Day 7: Packaging, Labeling, and Storage

Objectives:
• Select appropriate packaging materials for compounded products
• Apply labeling requirements per regulatory guidelines
• Understand storage conditions and stability considerations
• Implement proper dispensing and patient counseling

Topics:
• Packaging materials: containers, closures, and child-resistant packaging
• Labeling: contents, expiry, storage, and warnings
• Beyond-use dating and stability studies
• Storage conditions: temperature, light, humidity
• Dispensing procedures and patient information leaflets

Day 8: Quality Assurance and Risk Management

Objectives:
• Implement quality assurance systems in compounding
• Identify and mitigate risks in compounding processes
• Perform root cause analysis for compounding errors
• Understand the role of audits and inspections

Topics:
• Quality assurance: SOPs, batch records, and audits
• Risk management: failure mode effects analysis (FMEA)
• Error prevention and reporting systems
• Corrective and preventive actions (CAPA)
• Regulatory inspections and compliance

Day 9: Advanced Compounding and Special Populations

Objectives:
• Apply compounding skills to specialized patient groups
• Compound complex formulations such as transdermal systems
• Integrate compounding knowledge with clinical pharmacy practice
• Prepare for certification and professional development

Topics:
• Compounding for pediatric, geriatric, and veterinary patients
• Transdermal and topical drug delivery systems
• Compounding of hormonal preparations
• Clinical case studies and compounding challenges
• Professional development and certification pathways

Practicals

27 hours of practicals To be conducted online or on-campus or in-house
Overview

The practicals provide hands-on experience in compounding techniques, aseptic manipulations, and quality control testing. Learners will apply theoretical knowledge in a simulated pharmacy laboratory, preparing both sterile and non-sterile products under supervision.

Practical Activities
  • Practical 1: Non-Sterile Compounding – Ointments and Creams — Learners compound a cream and an ointment using various bases, incorporating active ingredients, and perform quality control tests such as pH and viscosity measurement. (6h)
  • Practical 2: Sterile Compounding – IV Admixtures — Learners prepare intravenous admixtures in a cleanroom environment, using aseptic technique, including laminar flow hood operation and proper garbing. (8h)
  • Practical 3: Capsule Filling and Quality Control — Learners fill hard gelatin capsules with a powder blend, perform uniformity tests, and evaluate dissolution using a USP apparatus. (6h)
  • Practical 4: Quality Assurance and Error Prevention — Learners simulate a compounding error scenario, conduct root cause analysis, and implement corrective actions. They also perform an internal audit of a compounding facility. (7h)

Summatives

Each delegate is assessed continuously throughout the course via daily exercises, scored practical assignments, and a final summative test at the end.

Practical Assignments — 30%

Practical assignments are observed and scored against a rubric during the practical sessions. Each delegate's practical mark is averaged into a single 100% score and contributes 30% to the final total.

Daily Exercises — 20%

Every training day ends with a multiple-choice exercise scored out of 100%. The scores from each daily exercise are averaged across the duration of the course to produce a Daily Average mark, which contributes 20% to the final total.

Final Test — 50%

On the last day a final summative test is written. It is a multiple-choice paper with multiple-answer questions: each question may have more than one correct option, and a single wrong selection on a question marks the entire question wrong — no partial credit. The final test is scored out of 100% and contributes 50% to the overall mark.

Final Total
Component Out of Weight
Practical Assignments (rubric-scored) 100% 30%
Daily Average (multiple choice) 100% 20%
Final Test (multi-answer multiple choice) 100% 50%
Final Total 100%

All marks are recorded on the AATICD LMS and visible to each learner under their account.

Certificate

Certificate of Completion

Awarded to delegates who achieve an overall mark of 50% or higher on the Final Total (Practicals 30% + Daily Average 20% + Final Test 50%).

How it works
  • Certificates are auto-generated on the AATICD LMS as soon as the marks pass the 50% threshold.
  • Each certificate is a branded PDF with the delegate's name, the course title, the unit standard ID, NQF level, credits, and the date of issue.
  • You can download or print your certificate from your LMS dashboard at any time after issue — there's no reissue fee and no expiry date.
  • If you scored under 50% you can sit the final test again at the next scheduled session at no extra cost.
Where to find it

Sign in to the LMS, open your dashboard, and your certificates appear under My Certificates. Each entry has a View / Download button and a print option.

Training Discounts

Group discounts apply automatically — the more delegates you enrol, the greater the saving. Discounts are calculated at 3% per 5 delegates, scaling up to 40% off for 100+ delegates.

Delegates Discount
5 3% off
10 6% off
15 9% off
20 12% off
25 15% off
30 18% off
50 30% off
75 35% off
100 40% off

3% discount per 5 delegates, up to 40% off for 100+ delegates. Contact us for a custom group quote.

Upcoming Training Sessions
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Training Discounts
Delegates Discount
5 3% off
10 6% off
15 9% off
20 12% off
25 15% off
30 18% off
50 30% off
75 35% off
100 40% off

3% off per 5 delegates, up to 40% for 100+

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