Good Manufacturing Practice (GMP) 02 (PIC/s GMP Part 2 – APIs)
Good Manufacturing Practice 02 (GMP Part 2) – Online GMP Training Course
The objectives for this GMP Part 2 online training module are to:
- introduce Good Manufacturing Practice (GMP) regulations relating to the manufacture of Active Pharmaceutical Ingredients (APIs)
- overview the GMP requirements for PI starting materials
- help learners understand the requirements for:
- manufacturing, including contract manufacturing
- personnel, premises, equipment and utilities
- managing equipment maintenance, cleaning and calibration
- production and laboratory controls
- managing materials
- packaging and labelling
- storage and distribution
- computerised systems
- explain the role of the Quality Unit and Pharmaceutical Quality System (PQS)
- discuss the importance of Quality Management, including change control
- comprehend GMP documentation and record-keeping requirements
- emphasise the importance of validation
Who should complete this GMP Part 2 training course?
- Any new or existing Manufacturing and Quality department personnel, suppliers or contractors involved in operations pertaining to Active Pharmaceutical Ingredients (APIs)
- Anyone needing to understand Good Manufacturing Practice (GMP) regulations specific to APIs
- Anyone requiring a current GMP Training Certificate for GMP Part 2 (Active Pharmaceutical Ingredients)
- Allow an average of 2 to 3 hours to complete this online training course including the Final Assessment.
- You can access the course online 24/7, once you complete your online order.
- You will continue to access this course for a period of 12 months from the date of purchase.
Is this a Certificate GMP course for GMP Part 2?
- Successful completion of the Final Assessment for Good Manufacturing Practice 02 (GMP Part 2) provides you with a Certificate of Completion for the GMP training topic.
- To attain a GMP course certificate of completion, simply spend time reviewing the online course materials, take the Quick Quizzes to test your knowledge, and then successfully complete the online Final Assessment for the course.
- After successful completion of each course, you’ll have the option of printing or saving a personalised GMP Training Certificate that meets general PIC/S GMP and EU GMP regulatory expectations.
- You can download/save, print and/or forward the GMP Part 2 training Certificate of Completion to your Quality Manager, Supervisor or Personnel Hiring Department for GMP industry job openings.
Pre-requisites for the GMP Part 2 training course:
- There are no formal pre-requisites for this course, however, completion of GMP01 (Part 1) is strongly recommended.
- The 10 Golden Rules of GMP may also be a helpful course to take as an orientation to the principles of GMP compliance, depending on previous experience in a regulated sector.
- The training course should be combined with onsite training programs and workplace Supervision.
Subsequent GMP courses after PIC/s GMP Part 2 Training
Other recommended Good Manufacturing Practice (GMP) training courses:
The following GMP courses are crucial for success in highly-regulated industries:
- Good Manufacturing Practice 01 (GMP Part 1)
- Good Record-Keeping Practice (Good Documentation Practice)
- Other PIC/s requirements for Annexes 1 through 20 are available from this training store page
- Good Laboratory Practice (GLP nonclinical)
- GMP Refresher training
- Please see our other courses in the event you need training on FDA’s CFRs 210 & 211, CFRs 800 & 820
Ask your Employer for details or visit our industry-specific training bundles.
These courses are intended for use as GMP orientation training courses/GMP Industry education resources. They are designed to be used as supplemental GMP training, orientation training, and annual refresher courses in conjunction with specific onsite GMP training and Supervision as required in the pharmaceutical manufacturing sectors.
It is helpful for learners to develop deeper understandings of basic GMP principles and GxP compliance regulations, such as through learning the GMP topics covered in GMP01/GMP Part 1, and industry-specific courses.
Do you have to be currently employed in the Pharmaceutical Industry to take a Good Manufacturing Practice course (such as GMP Part 2) covering Active Pharmaceutical Ingredients (APIs)?
- The course is open to anyone with an interest in the Pharmaceutical Industry, GMP compliance requirements for working with APIs during pharmaceutical manufacturing or supply chain transportation, and related manufacturing topics.
- Other relevant courses can be found in our list of online GMP training courses / cGMP training options.
- Good Recordkeeping practice training is also recommended for all employees as recordkeeping and documentation are often cited in warning letters from Regulatory Authorities such as the TGA, MHRA and FDA.
Page last updated on April 28, 2021.