This interactive GMP eLearning course provides a straightforward, high-level introduction to Good Manufacturing Practice (GMP) regulatory compliance requirements, structured around the 10 fundamental Golden Rules that underpin every effective GMP compliance programme. It is one of the most widely applicable GMP courses available — suitable as an induction course for new employees and as an annual refresher for experienced personnel in pharmaceutical, veterinary medicines, and medical device manufacturing environments.
- Get the facility design right from the start
- Validate processes
- Write good procedures and follow them
- Identify who does what
- Keep good records
- Train and develop staff
- Practice good hygiene
- Maintain facilities and equipment
- Build quality into the whole product lifecycle
- Perform regular audits
- New employees requiring GMP orientation or induction training
- Existing employees requiring annual GMP refresher training
- Contractors, suppliers, and managers in regulated industries
- Personnel in warehousing, logistics, and supply chain roles
- New graduates and job applicants entering the pharmaceutical sector
- Individuals re-entering the GMP industry after a career gap
- Cosmetic manufacturing personnel also governed by GMP guidelines
- PIC/S GMP Guide (55+ member authorities)
- US FDA (21 CFR Parts 210/211, 820)
- EU EMA / EudraLex Volume 4
- Australian TGA
- UK MHRA
Good Manufacturing Practice 01 provides a comprehensive introduction to GMP Part 1 regulations as described in the PIC/S GMP Guide — the internationally harmonised standards governing the manufacture of medicinal products for human use. The course covers the Pharmaceutical Quality System, personnel and contractor responsibilities, production controls, documentation practices, quality risk management (ICH Q9), global regulatory authority oversight, and the 10 Golden Rules of GMP. This course is suitable for new or existing personnel in pharmaceutical manufacturing and quality roles, as well as suppliers and contractors.
- Introduce PIC/S GMP Part 1 regulations for medicinal products including contract manufacturing
- Understand common GMP industry terms and definitions
- Explain the Pharmaceutical Quality System (PQS) and QMS requirements
- Overview GMP responsibilities for personnel, suppliers, and contractors
- Learn the importance of production quality controls and batch records
- Understand Good Documentation Practice and ALCOA+ principles
- Explain Risk Management principles (ICH Q9) for quality and patient safety
- Reinforce the 10 Golden Rules and GMP compliance culture
- Provide orientation to global regulatory authorities (FDA, TGA, EMA, MHRA)
- New or existing Manufacturing and Quality department personnel
- Suppliers and contractors in medicinal product operations
- Anyone requiring a GMP training certificate for pharmaceutical roles
- Individuals applying for jobs in the pharmaceutical industry
- Regulatory Framework & PIC/S Overview
- GMP Terms & Definitions
- Pharmaceutical Quality System (PQS / ICH Q10)
- Personnel, Suppliers & Contractors
- Production Quality Controls & BMRs
- Good Documentation Practice (ALCOA+)
- Risk Management (ICH Q9)
- Regulatory Authorities & Inspections
- 10 Golden Rules & GMP Culture
Good Manufacturing Practice 02 provides comprehensive training on the GMP requirements that govern the manufacture of Active Pharmaceutical Ingredients (APIs) and intermediates, aligned with PIC/S GMP Part II (ICH Q7). Covering the full API manufacturing lifecycle — from starting material definition and supplier qualification through synthesis, in-process controls, laboratory testing, packaging, storage, distribution, computerised systems, and validation — this is the definitive online GMP training course for anyone working in or with API manufacturing environments.
- Introduce GMP regulations specific to API manufacture (ICH Q7)
- Overview GMP requirements for API starting materials and supplier qualification
- Understand manufacturing requirements including contract manufacturing
- Cover personnel, premises, equipment, and utilities requirements
- Manage equipment maintenance, cleaning validation, and calibration
- Understand production controls, IPC, and yield reconciliation
- Address laboratory controls, OOS investigations, and method validation
- Cover materials management, packaging, labelling, storage, and distribution
- Address computerised systems (21 CFR Part 11, Annex 11, GAMP 5)
- Explain documentation, validation, and change control requirements
- Manufacturing and Quality personnel in API manufacturing
- Suppliers and contractors in API operations or supply chain
- Finished product manufacturers who need to understand API supplier expectations
- Job applicants seeking roles in API manufacturing, QC, QA, or supply chain
- Anyone requiring a GMP certificate covering API-specific requirements
- Regulatory Framework & ICH Q7 (GMP applicability)
- Quality Unit & Quality System
- Personnel, Premises & Utilities
- Equipment — Maintenance, Cleaning & Calibration
- API Starting Materials
- Production & In-Process Controls
- Laboratory Controls & OOS Investigations
- Materials, Packaging, Labelling & Distribution
- Computerised Systems & Data Integrity
- Documentation, Validation & Change Control
Good Documentation Practice (GDocP) — also known as Good Recordkeeping Practice (GRK) — is one of the most universally applicable and frequently cited compliance requirements across all GMP-regulated industries. This course covers the complete ALCOA+ framework for data integrity, the only correct method for correcting errors in GMP records, what personnel must and must not do when creating and maintaining records, and the requirements for electronic records and audit trails under 21 CFR Part 11 and EU GMP Annex 11. This course is recommended to be completed at least annually by all regulated industry personnel.
- Understand why Good Documentation Practice is critical to GMP compliance
- Master the ALCOA+(+) framework — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available
- Learn the correct and only acceptable method for correcting errors in GMP records
- Understand what you should do when creating and maintaining GMP records
- Understand what you should not do — including backdating, pre-signing, selective reporting, and use of correction fluid
- Learn GRK/GDocP principles for paper, hybrid, and electronic records
- All employees of regulated industries — pharmaceutical manufacturing, medical devices, veterinary medicines, hospitals, laboratories
- Logistics, warehousing, and supply chain personnel in regulated environments
- Contractors and suppliers who create or handle GMP records
- Managers and quality personnel who review and approve GMP documentation
- Why GDocP Matters — consequences of documentation failures
- ALCOA — Attributable, Legible & Contemporaneous
- ALCOA — Original & Accurate
- ALCOA+ — The Extended Principles (Complete, Consistent, Enduring, Available)
- Correcting Errors in GMP Records — the one compliant method
- What You Should Do — good recordkeeping practices
- What You Should NOT Do — prohibited practices & data integrity violations
- Electronic Records, Batch Records & Data Integrity (21 CFR Part 11, Annex 11)
This Good Warehouse Practice (GWP) training course covers the standards required to maintain the quality, integrity, and safety of pharmaceutical products and medical devices within a warehouse environment. From warehouse layout management and goods receipt through product traceability, stock handling, environmental and pest control, and shipping operations — this course equips every member of a pharmaceutical warehouse team with the practical knowledge to meet GWP and GDP compliance requirements and to play their part in protecting patient safety.
- Understand why Good Warehouse Practice is important for patient safety
- Understand warehouse layout management — zones, segregation, and access control
- Learn how to manage the receipt of goods — receiving inspection, supplier verification, quarantine
- Understand how to handle rejected goods, returns, recalls, expired stock, and counterfeits
- Understand how to ensure product traceability — batch-level, from receipt to dispatch
- Understand good storage practices — FEFO, storage conditions, and housekeeping
- Understand environmental controls — temperature monitoring, cold chain, humidity — and pest control
- Understand shipping, picking, and packing requirements — including dispatch verification
- Warehouse receiving, storage, and dispatch personnel
- Warehouse supervisors and managers
- Pickers, packers, and forklift operators
- Quality Assurance and GDP Responsible Persons
- Logistics and supply chain personnel
- Anyone seeking employment in pharmaceutical or medical device warehousing
- Why GWP Matters — patient safety and regulatory consequences
- Warehouse Layout Management — zones, segregation, special areas
- Receipt of Goods — 9-step receiving inspection and quarantine
- Rejected Goods & Returns — handling, conditions for re-release, destruction
- Product Traceability — batch-level records and mock recalls
- Good Storage Practices — FEFO rotation, storage conditions, housekeeping
- Environmental Controls & Pest Control — temperature monitoring, IPM
- Shipping, Picking & Packing — pick controls, cold chain dispatch, verification
This self-directed online course describes the key components of Current Good Manufacturing Practices (cGMP) as published in Title 21 of the FDA's Code of Federal Regulations, Part 117 (21 CFR 117), with specific application to fresh produce processing. Participants gain the skills to develop and implement effective GMPs and to describe the methods, equipment, facilities, and controls required for producing safe processed food products.
- Navigate key elements of GMP requirements for fresh produce production
- Identify food safety risks associated with fresh produce processing environments
- Understand requirements to minimise risks in a fresh produce processing environment
- Apply personnel hygiene, facility design, sanitation, and equipment GMP requirements in practice
- Understand warehousing, distribution, and recordkeeping obligations under 21 CFR 117
- Food safety professionals in fresh produce processing
- Production supervisors, managers, and operators
- Quality Assurance and Quality Control personnel
- Workers in washing, trimming, packaging, and sprout operations
- Anyone requiring cGMP employee training under 21 CFR 117.4(b)(2)
- Regulatory Framework & GMP Overview (21 CFR 117)
- Personnel Practices & Hygiene
- Plant & Grounds Requirements
- Sanitary Operations (cleaning, sanitising)
- Sanitary Facilities & Controls (water, plumbing)
- Equipment & Utensils
- Processes & Controls (temperature, wash water)
- Warehousing, Distribution & Records
NPGMA — National Produce & Growers Manufacturing Association
All NPGMA online training courses are self-paced, certificate-bearing eLearning programmes designed for regulated industry professionals. Courses are available 24/7 for 12 months from date of enrolment. Certificates of Completion meet general regulatory expectations for training documentation and may be included in personnel training records, submitted to Quality Management or HR departments, and attached to résumés for regulated industry job applications.
These courses are intended as orientation training, annual refresher resources, and supplemental compliance education. They are designed to be used in conjunction with site-specific onsite GMP training, standard operating procedures, and appropriate workplace supervision as required in pharmaceutical, medical device, and other regulated manufacturing sectors. eLearning courses do not replace onsite, product-specific, or site-specific training programmes.