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Key Learning Objectives

On completion of this QP pharmaceutical packaging course, delegates will know and understand:

• The QP study guide expectations for packaging
• Background on different packaging materials and their selection, uses control and impact on product stability
• Packaging design considerations to protect both the product and the patient including labelling, anti-counterfeiting, tamper evidence and serialization
• Regulatory aspects of tablet, vial and bottle packaging
• Supply chain management from supplier selection to contract manufacturing organizations (CMOs), distributors, storage, transportation and the patient
• Packaging operations and their risks and control
• New changes and challenges to packaging
• Packaging issues impacting QP and quality assurance (QA) decisions

Course Outline

Packaging components

• Primary (contact) materials, their composition and properties
• Choosing the most appropriate material for specific applications
• Artwork management
• Requirements for receipt, sampling and testing
• Supplier considerations, audits, agreements and standards, e.g. PS 9000

Regulatory aspects

• Stability testing requirements
• Labelling regulations
• Marketing authorization application requirements for packaging components

Pack design

• Good design practices to aid the manufacturer, distributor, retailer and patient
• Reducing the risk of mix-up

Packaging process

• Packaging operations (the GMP challenges)
• Facility design considerations
• Packaging machinery (selection and qualification)
• Process qualification and validation
• Automatic security and detection systems
• Start-up checks and in-process controls
• Line clearance and cleaning
• Batch packaging record design and reconciliation

Route to the patient

• Fundamentals of Good Distribution Practice (GDP)
• Controlled temperature storage and distribution
• Wholesale dealing (includes a visit to a wholesaler)

Concerns for the QP

• Counterfeits (anti-counterfeiting, tamper evidence and serialization)
• Controlling packaging processes

Discussion and working groups

A significant portion of course time is devoted to group work. Using case studies, delegates get the opportunity to put theory into practice. Additionally, discussion periods (which include a course tutor panel session) provide you with an opportunity to obtain answers to your specific question and concerns.

Who Should Attend?

The aspiring Qualified Person

• Our training is generally considered as the best available and our QPs are held in high regard in the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.

The pharmaceutical technical professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact [email protected]

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit for further information. If you cannot see your delivery method of choice, please contact [email protected].