This course introduces the general principles and purpose of Good Manufacturing Practice and the specific GMP regulations for the manufacture of Active Pharmaceutical Ingredients (API).
Who should complete this Bundle?
This entry level bundle is ideal for all production and quality personnel involved in the manufacture of Active Pharmaceutical Ingredients (API). This course is suitable for use as an induction for new starters or as refresher training for experienced staff.
Module 1: Good Manufacturing Practice 01
This interactive e-Learn provides an introduction to the basic principles of Good Manufacturing Practice. It is suitable for all personnel who work within a GMP regulated environment.
The objectives of the Good Manufacturing Practice module are:
- to understand the basic purpose, elements, and implementation of GMP
- to understand the intent and scope of GMP
- to understand who enforces GMP regulations and the importance of GMP
- to understand the basics of GMP, correcting errors, date formats, hygiene, etc
Module 2: Good Manufacturing Practice for Medicinal Products – API
This e-Learning module provides and understanding of the GMP regulations covered by Part II of the PIC/s GMP guide relating to the manufacture of Active Pharmaceutical Ingredients (API). Many concepts in Part I are duplicated in Part II.
The objectives of this training module are:
- to understand the distinct roles of Manufacturing and Quality Assurance units
- to understand the purpose of Quality Management
- to understand the requirements for personnel, premises, equipment and utilities
- to understand the management of equipment maintenance, cleaning and calibration
- to understand the management of materials and packaging
- to understand the requirements for storage and distribution
- to understand the requirements for reject/rework/reprocess of product
- to understand the importance of documentation
- to understand the importance of validation
Module 3: Good Record Keeping 01
This e-learning module introduces participants to Good Record Keeping Practice. This module is essential for all personnel who complete or review batch records, log books and any other GMP documentation.
The objectives of the Good Record Keeping module are:
- to understand why record keeping is so important
- to understand how to delete or strike out errors
- to understand what you should do when creating records
- to understand what you should not do when creating records
Module 4: The 10 Golden Rules of GMP
This interactive e-Learn provides a straightforward guide to cGMP in the form of the 10 golden rules. Keep these easy-to-remember rules in mind when making GMP decisions.
After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meets regulatory GMP requirements.
Bundle price is per person and includes 12 months access to the four modules.