Active Pharmaceutical Ingredients (APIs)

Description

Active Pharmaceutical Ingredients (APIs) GMP Compliance Training Course

Description

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).

Modules included in this GMP training bundle:

• The 10 Golden Rules of Good Manufacturing Practice (GMP)
• Good Manufacturing Practice 01 (GMP Part 1)
• Good Manufacturing Practice 02 (GMP Part 1)
• Good Record-Keeping Practice (GRK, also called Good Documentation Practice/GDocP)

Who should complete this “Active Pharmaceutical Ingredients (APIs) GMP compliance training” bundle of four (4) eLearning modules?

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 an 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, logbooks 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.

GMP Training – Certificates of Completion

After successful completion of each course in the APIs GMP Compliance training bundle, you will have the option of downloading, printing and/or saving your personalised Training Certificate of Completion (that meets regulatory GMP requirements).

The training bundle price is per person and includes instant 12 months’ access to all four training modules.

This GMP training course bundle on API regulations includes four essential training modules for understanding the basics of Good Manufacturing Practice (GMP), particularly for personnel, contractors and suppliers working within a facility that manufactures Active Pharmaceutical Ingredients (APIs) or is involved in the API supply chain.

Active Pharmaceutical Ingredient(s) GMP Regulations Training Bundle

Inclusions in this discounted GMP training bundle include the following key GMP orientation modules:

• The 10 Golden Rules of Good Manufacturing Practice (GMP)
• Good Manufacturing Practice 01 (GMP Part 1)
• Good Manufacturing Practice 02 (GMP Part 1)
• Good Record-Keeping Practice (GRK, also called Good Documentation Practice/GDocP)

Course Duration for the API / GMP Training Bundle

Completion Timeframes for these courses will vary from person to person.

In general, courses in this GMP training bundle range from a minimum of 30 minutes each to up to 3 hours to complete.

Suggested time allowances to complete all four individual GMP Training Certificate Courses (online modules)

To complete all four (4) modules in this training bundle that introduces GMP requirements for Active Pharmaceutical Ingredients (APIs), learners should allow from a minimum of 6 hours to 8 hours including time to complete the Final Assessments on all four (4) modules in this API training bundle (discount GMP training package).