This interactive e-learning module on Annex 1 – Sterile Medical Products introduces GMP regulations specific to the manufacture of sterile medicines, as found in EU Annex 1 & PIC/S Annex 1, including cleanroom gowning requirements. This Annex 1 GMP compliance training eLearning course is essential for personnel who work within the areas of final fill and finish; environmental monitoring; and/or sterility assurance.
Regulatory Compliance with Annex 1 (PIC/S & EU GMPs)
This Annex 1 training course is based on PIC/S Annex 1 compliance requirements & EU Annex 1 requirements for the Manufacture of Sterile Medicinal Products.
Annex 1 Compliance Topics you’ll learn by completing this online course
Introduce specific regulations for the manufacture of sterile medicines as found in EU Annex 1 and PIC/S Annex 1
Explain the principles of sterile manufacturing
Provide details on the types of sterile manufacturing
Provide an understanding of cleanroom classification and monitoring
Understand personnel requirements, including cleanroom garments/cleanroom gowning requirements
Cleanroom behaviours and quality controls
Understand the requirements for sterile manufacturing premises
Emphasise the importance of sterilisation and sanitation
Provide details on the different sterilisation methods
Explain the importance of Pharmaceutical Quality Systems (PQS) / Quality Control
The regulations outlined in this module do not apply to non-sterile manufacturing facilities.
However, it is possible to draw valuable good practice guidance for non-sterile facilities.
PIC/S Annex 1 – Sterile Medicinal Products – your eLearning resources for blended learning experiences
PharmOut’s Annex 1 training course introduces PIC/S & EU GMP compliance requirements for the manufacture of medicinal products that are subject to special requirements to minimize risks of microbiological contamination (Sterile Medicinal Products).
Intended Audience for this course
Who should complete this Annex 1 training course introducing PIC/S GMP compliance requirements for the manufacturer of Sterile Medicinal Products
Personnel and contractors who work within the areas of final fill and finish environmental monitoring or sterility assurance
Anyone needing foundational training in GMP compliance for sterile products
Anyone requiring a GMP Training Certificate relating to products that must meet PIC/S Annex 1 GMP compliance requirements
PIC/S Annex 1 Compliance Training/Education: GMP Certificate Training Course
Course Details & Course Duration
Course Duration for this annex 1 online presentation can vary, based on your existing knowledge of the topic and your learning style.
As an average time frame to complete this Annex 1 compliance course, allow 1-2 hours including the Final Assessment.
You can access the course online 24/7, once you complete your online purchase.
You will continue to access this course for a period of 12 months from the date of purchase.
Purchase easily online by adding to your cart (scroll up to the top of this page to see that option)
Certificate GMP Course for EU & PIC/S Annex 1 – Manufacture of Sterile Medicinal Products
Is this a Certificate GMP course in relation to Sterile Medicine regulations?
Yes, this course provides a Certificate of Completion for this Annex 1 education topic.
Successful completion of the Final Assessment for the training course is required to gain your Certificate of Completion for your personnel/training records and/or to attach to your CV for a job application in the sterile medicine production industry
To attain a GMP course certificate of completion:
Spend time reviewing the online course materials
Take the Quick Quizzes to test your knowledge, and
Successfully complete the online Final Assessment for the course
After successful course completion of this GMP compliance education topic, you can print or save a personalised GMP Training Certificate that meets general PIC/S GMP and EU GMP regulatory expectations.
Pre-requisites for this Introduction to Annex 1 training course
There are no formal pre-requisites for this course, however, it really helps to have taken other courses in GMP compliance prior to completing this more advanced topic specific to sterile manufacturing. The following induction courses to the pharmaceutical industry may help you gain the pre-requisite knowledge you require to better understand your GMP compliance responsibilities in the pharmaceutical manufacturing and/or medical device manufacturing industry.
10 Golden Rules of GMP may be a helpful course 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.
Other recommended eLearning for Good Manufacturing Practice compliance
The following courses are also crucial for success in a GMP environment. These are recommended for before or after your completion of the Annex 1 Certificate GMP training course.
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.
Course summary
EU & PIC/S Annex 1 – Sterile Medicines eLearning Agenda
The objectives of this training module are to help professionals and contractors in the sterile manufacturing industry to understand:
principles of sterile manufacturing
types of sterile manufacturing
cleanroom classification and monitoring
personnel requirements including garments (cleanroom gowning requirements)
requirements for sterile manufacturing premises and equipment
Do you have to be currently employed in the Pharmaceutical Industry to take a Certificate GMP Course, such as the GMP compliance training for PIC/S Annex 1?
You do not have to be currently employed in the pharmaceutical industry to take this GMP training course.
The course is open to anyone with an interest in the Pharmaceutical Industry and/or GMP compliance requirements for working with medicinal products during pharmaceutical manufacturing or supply chain transportation, and related manufacturing topics.
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.
