Annex 1 – Sterile Medicinal Products (Rev 1. Updates)

Description

PIC/S Annex 1 (Rev 1) – Sterile Medicinal Products eLearning

This certificate GMP Training Course covers the updated PIC/S Annex 1 guidance for the manufacture of Sterile Medical Products.  This course is designed to support personnel, contractors, and service providers who work in manufacturing, operations, quality management , engineering, packaging, distribution, and/or inspection roles (e.g., Regulatory Authority representatives).

Suitable for a global audience.

This cGMP training presentation provides a convenient, self-paced eLearning format to learn the compliance rules for sterile manufacturing. Its interactive format and inbuilt quizzes and assessments are an excellent way to learn and/or reinforce your compliance knowledge in relation to the recently updated PIC/S & EU Annex 1 guidelines for sterile medicines manufacturing.

Training Course Benefits

• Learn the cGMP/GMP compliance requirements for the Manufacture of Sterile Medicines as per the PIC/S & EU Annex 1 (R1) guidance publications.
• Online cGMP training courses are designed to assist compliance knowledge and to facilitate a cGMP compliance culture and to help protect public health and patient safety.

cGMP Certificate Training Course for Annex 1(Sterile Medicines)

What does this Annex 1 GMP Compliance training course cover?

Information in this course for sterile product manufacturing (cGMP compliance training) is relevant to:

• The updated EU Annex 1 guidance; published by the European Union on the 25th of August, 2022; and
• The updated PIC/S Annex 1 (Rev 1) guidance for the Manufacture of Sterile Medicinal Products; published by the Pharmaceutical Inspection Cooperation Scheme on 9 September 2022.
• The updated PQS requirements for Contamination Control Strategy (CCS), sterile manufacturing methods and technologies, clean areas/cleanroom grades, contamination prevention and environmental monitoring controls, cleanroom gowning requirements (PPE), and an introduction to the requirements for process and equipment validation and qualification.

Updated Annex 1 (R1) Guidance

 

Why is completing Annex 1 compliance training important?

Complying with the recently updated guidance in PIC/S Annex 1 (and EU Annex 1) is essential for personnel working within the areas of final fill and finish/operations; cleanroom operations, environmental monitoring; quality controls including cleanroom facility and equipment maintenance, and sterility assurance.

Overview of this online GMP Training Course

• This Annex 1 (R1) GMP compliance eLearning course covers recent updates to PIC/S Annex 1, published by PIC/S on 9 September 2022, which are in force as of August 25, 2023; and EU Annex 1 GMP guidance.
• It includes an online assessment that provides learners with a GMP training Certificate of Completion for personnel training records relevant to Annex 1.
• This GMP eLearning course for Annex 1 will help employees, contractors, Inspectors/auditors, and other sterile manufacturing stakeholders to better understand the recent updates to EU Annex 1 & PIC/S Annex 1 (GMP compliance requirements related to the manufacture of sterile medicinal products/sterile medicines).

Course Agenda

Key topics covered in this online GMP training course for Annex 1 (Rev 1) compliance include:

• Important information relevant to complying with the updated Annex 1 (Revision 1) guidance publication PS/ INF 26/2022) (Revision 1) and related regulations (laws) for the manufacture of sterile medicinal products
• Principles of sterile manufacturing (EU Annex 1 and PIC/S Annex 1) and contamination prevention/production controls
• Different types of sterile manufacturing (aseptic processing, terminal sterilisation)
• Annex 1 requirements for APS (aseptic process simulations)
• Cleanroom grades (cleanroom classifications)
• Cleanroom conditions & environmental monitoring requirements
• Personnel requirements, including cleanroom garments (required PPE, gowning qualification requirements)
• Cleanroom behaviours and other quality controls
• Requirements for sterile manufacturing premises and equipment
• Importance of sterilisation and sanitation
• The importance of the Pharmaceutical Quality Systems (PQS) and Contamination Control Strategy (CCS) for sterile manufacturing

Sterile medicine products are subject to special GMP requirements to minimise the risks of microbial contamination, particulate contamination, and/or endotoxin/pyrogen contamination.

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.

Who should complete this Annex 1 training course for the manufacturer of Sterile Medicinal Products?

People who will benefit from this updated Annex 1 (Rev 1) certificate GMP training course include:

• Personnel and contractors who work within the areas of production and/or quality. management, including final fill and finish, environmental monitoring, sterility assurance, validation, etc..
• Anyone needing foundational training in GMP compliance for sterile medicines including contractors.
• Anyone requiring a GMP Training Certificate relating to products that must comply with PIC/S /EU Annex 1 GMP requirements/relevant quality and safety standards.
• Individuals applying for current job openings in the Pharmaceutical Industry (e.g. in the USA or Australia)
• Service providers/maintenance personnel in sterile manufacturing environments.
• Other industry suppliers involved with sterile medicines production and/or distribution.

Training Course Details

GMP Certificate Training Course for PIC/S Annex 1 

• Average completion time frames for this GMP education topic is 2 to 4 hours, including the Final Assessment.
• Successful completion of the Final Assessment will provide the learner with a Certificate of Completion.
• Time frames can vary based on pre-existing knowledge, individual learning styles, and other factors.
• Learners can access the online GMP course (24/7) for 12 months from date of purchase.
• Purchase easily online by adding to your cart (scroll up to the top of this page).
• If you need 4 or more courses per learner, consider the bundles option (tab).

Gain your GMP Training Certificate for Manufacture of Sterile Medicinal Products (Annex 1)

• Successful completion of the Final Assessment for the training course is required to gain your Certificate of Completion for your personnel/training records or to attach to your CV for a job application in the pharmaceutical sector.
• 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 prerequisites for this course. However, it helps to have completed other GMP training courses prior to completing this more advanced topic (sterile manufacturing PQS & GMP requirements). For example, GMP training or experience in a GMP environment is useful prior to completing this particular course (see course suggestions below).

Disclaimer – Education purposes only

This course is for education purposes only. It is intended to support but not replace product-specific training and adequate Supervision. It should never be used for decision-making purposes.

The training course is best combined with onsite training and product-specific training/PIC/S Annexes. Adequate workplace Supervision is required for compliance.

For best practice GMP training, learners should read the full copy of the regulations in addition to completing this course.

 

Other useful training for Sterile Manufacturing Personnel & Service Providers

Other training courses will assist learners to develop a deeper understanding of basic GMP principles and GxP compliance regulations.

The following induction courses to the pharmaceutical industry may help learners gain pre-requisite knowledge of Good Manufacturing Practice (GMP) personnel responsibilities in the pharmaceutical manufacturing and/or medical device manufacturing industry.

• Good Manufacturing Practice 01 (GMP Part 1) for medicinal products
• Good Manufacturing Practice 02 (GMP Part 2) for active pharmaceutical ingredients (APIs)
• 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.
• Medical Device industry standards (ISO) and regulatory compliance training courses

Depending on the learner’s role and industry requirements, consider the following supplemental cGMP Certificate Courses:

• Good Record-Keeping Practice (Good Documentation Practice)
• GMP Refresher training
• FDA CFR compliance training if relevant (e.g. FDA CFRs 210 & 211, FDA CFRs 800 & 820.
• PIC/s requirements for Annexes 1 through 20

Online training courses are also available for Pharmacovigilance and for the management of Complaints, Deviations & Non-conformances, and Recalls for medicines, medical devices, and other therapeutic products.

Need more compliance training?

Ask your Employer for details or visit the BUNDLES pages for courses.  You can purchase the 20-course bundle and email us to assign specific courses to personnel (this allows for custom distribution of courses to more than one user, standard courses only). Note: Prices are in $USD.

Frequently asked questions (GMP FAQs)

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 our online GMP training courses.
• 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 and Data Integrity training courses are also recommended for employees, as recordkeeping compliance gaps are often cited during Audits (and in FDA warning letters); e.g. cited during inspections by the TGA, MHRA, EMA, FDA, and other Regulatory Authorities.

All rights reserved.