Description

PIC/S Annex 1 – Sterile Medicinal Products

PIC/S Annex 1 – Sterile Medicinal Products

This Annex 1 training course introduces PIC/S GMP compliance requirements for the manufacture of medicinal products that are subject to special requirements to minimize risks of microbiological contamination (Sterile Medicinal Products).

The good manufacturing practice (GMP) regulations outlined in this Annex 1 online training module do not apply to non-sterile manufacturing facilities. However, it is possible to draw valuable good manufacturing practice (GMP) guidance for non-sterile facilities.

PIC/S Annex 1: GMP Compliance Training Course (Sterile Medicinal Products)

PIC/S Annex 1: GMP Compliance Training Course 

This Annex 1 training course is based on PIC/S Annex 1 requirements for the Manufacture of Sterile Medicinal Products.

The objectives of this Annex 1 training course are to:

• introduce the specific GMP regulations for the manufacture of sterile medicines as found in EU 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 garments
• understand the requirements for sterile manufacturing premises
• emphasise the importance of sanitation
• provide details on the different sterilisation methods
• explain the importance of Quality Control

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 GMP Certificate Training Course

Course Duration

• Allow an average of 1-2 hours to complete this online training course 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.

Certificate GMP Course for Annex 1 (Manufacture of Sterile Medicinal Products)

Is this a Certificate GMP course?

• Successful completion of the Final Assessment for the training course based on PIC/S Annex 1 GMP requirements 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 this Annex 1 training Certificate of Completion to your Quality Manager, Supervisor or Personnel Hiring Department for GMP industry job openings.

Pre-requisites for this Introduction to Annex 1 training course:

• 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.
• The training course should be combined with onsite training programs and workplace Supervision.

Other recommended Good Manufacturing Practice training courses:

The following other courses crucial for success in a GMP environment are recommended after the completion of this Annex 1 GMP compliance Certificate online training course:

• Good Record-Keeping Practice (Good Documentation Practice)
• GMP Refresher training
• Please see our other courses in the event you need training on FDA CFRs 210 & 211, FDA CFRs 800 & 820.
• Other PIC/s requirements for Annexes 1 through 20 are available from this certificate course GMP training store page.

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.

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 for medicinal products and GMP02/GMP Part 2 if working with APIs, and industry-specific courses.

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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