Annex 1 – Sterile Medicinal Products

USD $35.00

Course duration: Allow 1 to 2 hours to complete this course.

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PIC/S Annex 1 – Sterile Medicinal Products eLearning

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 annex1-pics-annex-1-sterile-medicinal-products-gmp-regulations

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
  • Individuals applying for current job openings in the Pharmaceutical Industry (e.g. in the USA or Australia)

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)

PIC/S or PICS Annex 1-GMP-Sterile_Medicinal_Products_cGMP_regulations

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.

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.

Ask your Employer for details or visit our industry-specific training bundles.

Education purposes only

  • 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
    • importance of sanitation
    • different sterilisation methods
    • importance of Quality Control

It is helpful for learners to develop a deeper understanding of basic GMP principles and GxP compliance regulations. This can be accomplished, ideally before completing the Annex courses, by completing GMP01/GMP Part 1 eLearning for medicinal products (and GMP02/GMP Part 2 eLearning if working with APIs) and other GMP industry-specific education programs/courses.

View our GMP industry education program – GMP employee induction packages.

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.
  • Other relevant GMP training 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.

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