Health Sciences and Social Services Curative Health

Large Scale Pharmaceutical Product Manufacturing Training

SAQA US 256481 | NQF 3 | Credits 12 | Duration 9 Days
From $1,798 per delegate

Description

This course equips learners with the knowledge and skills to manufacture pharmaceutical products on a large scale, ensuring compliance with Good Manufacturing Practices (GMP), safety regulations, and quality standards. It covers the entire production process from raw material handling to final product packaging, emphasizing contamination control and batch documentation.

Learning Outcomes

  • Apply GMP principles to pharmaceutical manufacturing operations on a large scale.
  • Demonstrate correct procedures for handling, weighing, and dispensing raw materials.
  • Implement contamination control measures in production areas.
  • Monitor and document critical process parameters during manufacturing.
  • Evaluate finished product quality against specifications and regulatory requirements.
  • Analyze batch records and identify deviations for corrective action.

Target Audience

Ideal for production supervisors, process operators, and quality assurance personnel in pharmaceutical manufacturing facilities who require formal training in large-scale production processes.

Prerequisites

None — open enrollment.

Course Outline

Day 1: Introduction to Large Scale Pharmaceutical Manufacturing

Objectives:
• Understand the scope and importance of large scale pharmaceutical manufacturing
• Identify regulatory frameworks and quality standards
• Describe the roles and responsibilities of manufacturing personnel
• Recognize key manufacturing processes and their sequence

Topics:
• Overview of pharmaceutical industry and manufacturing scale-up
• Regulatory bodies: SAHPRA, WHO, FDA, EMA
• Good Manufacturing Practice (GMP) principles
• Quality assurance vs quality control
• Manufacturing process flow: from raw material to finished product
• Safety and environmental considerations
• Documentation and record keeping basics

Day 2: Raw Materials and Warehousing

Objectives:
• Classify raw materials used in pharmaceutical manufacturing
• Understand receipt, sampling, and storage procedures
• Apply inventory management principles
• Identify risks and controls for material handling

Topics:
• Types of raw materials: active pharmaceutical ingredients (APIs), excipients, solvents
• Supplier qualification and material specifications
• Receiving and quarantine procedures
• Sampling and testing protocols
• Storage conditions: temperature, humidity, segregation
• Inventory management systems (FEFO, FIFO)
• Material dispensing and weighing
• Waste disposal and environmental controls

Day 3: Manufacturing Operations: Solid Dosage Forms

Objectives:
• Describe the steps for manufacturing tablets and capsules
• Understand equipment used in solid dosage production
• Identify critical process parameters
• Apply in-process controls and sampling

Topics:
• Granulation: wet and dry methods
• Milling and blending
• Compression and encapsulation
• Coating processes (sugar, film, enteric)
• Equipment: high-shear mixers, fluid bed dryers, tablet presses, capsule fillers
• In-process testing: hardness, friability, disintegration, weight variation
• Cleaning and changeover procedures
• Yield calculations and reconciliation

Day 4: Manufacturing Operations: Liquid and Semi-Solid Dosage Forms

Objectives:
• Understand manufacturing processes for liquids, suspensions, and creams
• Identify equipment and critical parameters
• Apply GMP in sterile and non-sterile liquid production
• Monitor quality attributes

Topics:
• Solutions, suspensions, emulsions: formulation and processing
• Semi-solids: ointments, creams, gels
• Mixing and homogenization equipment
• Filling and packaging lines
• Sterile manufacturing: aseptic processing, cleanroom classifications
• Sterilization methods: autoclaving, filtration, radiation
• In-process controls: viscosity, pH, uniformity
• Validation of mixing and filling processes

Day 5: Sterile Manufacturing and Aseptic Processing

Objectives:
• Explain principles of aseptic processing
• Describe cleanroom design and behavior
• Understand sterilization and depyrogenation
• Identify contamination control strategies

Topics:
• Aseptic processing vs terminal sterilization
• Cleanroom classifications (ISO 14644) and monitoring
• Personnel gowning and behavior
• Equipment sterilization and depyrogenation
• Media fill runs and process simulation
• Environmental monitoring: air, surfaces, personnel
• Lyophilization (freeze-drying) overview
• Validation of aseptic processes

Day 6: Packaging and Labeling Operations

Objectives:
• Understand packaging materials and their specifications
• Describe packaging equipment and processes
• Apply label control and serialization requirements
• Ensure product integrity and traceability

Topics:
• Primary and secondary packaging materials
• Blister packing, bottle filling, and cartoning
• Labeling: design, approval, and control
• Serialization and track-and-trace systems
• Packaging line setup and changeover
• In-process checks: seal integrity, label placement, batch coding
• Stability packaging considerations
• Case study: packaging deviations and corrective actions

Day 7: Quality Control and Quality Assurance in Manufacturing

Objectives:
• Differentiate QC and QA roles in manufacturing
• Understand sampling plans and testing methods
• Apply root cause analysis for deviations
• Interpret batch release processes

Topics:
• Quality control laboratory: testing of raw materials, in-process, finished products
• Pharmacopoeial methods (USP, BP, EP)
• Analytical techniques: HPLC, GC, dissolution, spectroscopy
• Stability studies and shelf-life determination
• Deviation management and CAPA
• Change control process
• Batch record review and disposition
• Internal and external audits

Day 8: Regulatory Compliance and Documentation

Objectives:
• Understand regulatory submissions and inspections
• Apply documentation practices (GDP)
• Identify compliance requirements for manufacturing
• Prepare for regulatory inspections

Topics:
• Regulatory dossier: CTD format, variations
• Inspection types: routine, pre-approval, for-cause
• Good Documentation Practice (GDP)
• Standard Operating Procedures (SOPs) and work instructions
• Training records and competency management
• Data integrity principles (ALCOA+)
• Recall procedures and mock recalls
• Case study: mock inspection preparation

Day 9: Integration, Continuous Improvement, and Trends

Objectives:
• Integrate knowledge across the manufacturing lifecycle
• Apply continuous improvement tools
• Understand emerging technologies in pharmaceutical manufacturing
• Develop a personal action plan for GMP compliance

Topics:
• Process validation lifecycle: design, qualification, continued verification
• Lean manufacturing and Six Sigma in pharma
• Process analytical technology (PAT) and real-time release
• Continuous manufacturing vs batch processing
• Quality by Design (QbD) principles
• Industry 4.0: automation, data analytics, AI
• Environmental sustainability in manufacturing
• Final assessment and course wrap-up

Practicals

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

Hands-on practicals are essential to reinforce theoretical concepts by simulating real manufacturing tasks. Learners will practice material dispensing, equipment operation, in-process testing, and documentation in a simulated GMP environment.

Practical Activities
  • Practical 1: Raw Material Dispensing and Weighing — Learners dispense and weigh APIs and excipients following a batch record, using calibrated scales and applying GMP procedures. (6h)
  • Practical 2: Tablet Compression and In-Process Testing — Learners operate a tablet press, adjust parameters, and perform in-process tests including hardness, weight variation, and friability. (6h)
  • Practical 3: Aseptic Technique and Environmental Monitoring — Learners practice aseptic gowning, media fill simulation, and environmental monitoring using settle plates and contact plates in a cleanroom. (6h)
  • Practical 4: Batch Record Review and Deviation Handling — Learners review completed batch records, identify discrepancies, and complete a deviation report with root cause analysis. (6h)

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
Online training — attend live sessions from anywhere via our virtual classroom.
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Thu 10 Sep 2026 Tue 22 Sep 2026 Virtual Spring 2026 $1,798 Register
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Mon 27 Dec 2027 Thu 06 Jan 2028 Virtual Summer 2027 $1,798 Register
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On-Campus training — face-to-face sessions at our training venues across Africa and beyond.
Showing all 522 sessions across 26 venues
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In-House training — we bring the trainer to your organisation, tailored to your team.
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Thu 08 Oct 2026 Tue 20 Oct 2026 Your Premises Spring 2026 $2,338 Register
Wed 28 Oct 2026 Mon 09 Nov 2026 Your Premises Spring 2026 $2,338 Register
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Wed 24 Mar 2027 Mon 05 Apr 2027 Your Premises Autumn 2027 $2,338 Register
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Fri 30 Jul 2027 Wed 11 Aug 2027 Your Premises Winter 2027 $2,338 Register
Thu 16 Sep 2027 Tue 28 Sep 2027 Your Premises Spring 2027 $2,338 Register
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Wed 15 Dec 2027 Mon 27 Dec 2027 Your Premises Summer 2027 $2,338 Register
Tue 04 Jan 2028 Fri 14 Jan 2028 Your Premises Summer 2027 $2,338 Register
Mon 24 Jan 2028 Thu 03 Feb 2028 Your Premises Summer 2027 $2,338 Register
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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