Pharmaceutical Packaging Systems - Part 2 - Quality Control - Live Online Training

27/28 November 2024

Course No. 21324

header-image

Speakers

Dr Gerald Kindermann

Dr Gerald Kindermann

GxP Consulting

Torsten Kneuss

Torsten Kneuss

Bayer

Peter Huonker

Peter Huonker

Lonza

Dieter Mößner

Dieter Mößner

Verpackungsexperte

Note: All times mentioned are CET.

Objectives

The focus of these 2 GMP Education Courses is on the development and routine control of pharmaceutical packaging systems.

In Course 1 participants will learn how to develop pharmaceutical packaging materials systematically, and how to translate the requirements of the Common Technical Document (CTD) to regulatory documents for packaging materials. Topics to be addressed include compendial standards, container closure integrity, and combination products.

Course 2 will focus on the testing of a variety of different packaging materials, as carried out in every incoming-goods laboratory in quality control. This includes the setting of sound and scientific specifications and Acceptable Quality Levels (AQLs), the control of dimensions, and the control of primary and secondary packaging materials.

Background

There are a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc. Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.

The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products and sterile packaging materials (Annex 1 of the EU GMP Guide). To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, but also current challenges such as package integrity, glass delamination and particles on ready-to-sterilize (RTS) and ready-to-use (RTU) components.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.

In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, Defect Evaluation Lists have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing & sampling at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.

Target Group

These GMP Education Courses are designed for employees working in pharmaceutical research and development, regulatory affairs, quality control, incoming goods control of packaging materials, and quality assurance departments. They are also directed at employees of suppliers of primary and secondary packaging materials for the pharmaceutical industry.

Technical Requirements

There are a great number of regulatory requirements on pharmaceutical packaging materials, in the pharmacopoeias, the GMP regulations, in the FDA guidances, etc. Packaging materials also have to be described in the registration process of a drug product according to the requirements of the CTD.

The development of pharmaceutical packaging systems is an increasingly complex topic, which is reflected in the most recent requirements for combination products and sterile packaging materials (Annex 1 of the EU GMP Guide). To cover all relevant aspects a thorough target product profile needs to be set up. Not only regulatory requirements drive container closure system development, but also current challenges such as package integrity, glass delamination and particles on ready-to-sterilize (RTS) and ready-to-use (RTU) components.

Furthermore, the pharmaceutical manufacturer has to guarantee that only such packaging materials are used that are correctly printed on, in conformity with the specifications and in compliance with the regulatory requirements.

In order to determine the scope of the tests for the quality control of pharmaceutical packaging materials, Defect Evaluation Lists have proved efficient. The responsibility for the tests lies now more and more with the manufacturers of packaging materials, while the pharmaceutical industry tries to reduce testing & sampling at the same time. However, as a precondition for this, additional QA measures, like supplier qualification, audits and supply agreements, have to be taken.

Programme

Pharmaceutical Packaging Systems - Part 2 - Quality Control - Live Online Training

Seminar Programme as PDF

Day 1 - 28 November 2024
 
Defect Evaluation Lists
  • Principles for the Defect Evaluation Lists (DELs)
  • Application of AQLs (Acceptable Quality Levels)
  • Examples for Containers made of moulded and tubular glass
Control of Printed Packaging Materials
  • Defect Evaluation Lists for Secondary Packaging Materials
  • Printing, Coding & Artwork
  • Serialization & Tamper Evidence
  • Defect classes and (100%) test procedures (Examples)
Technical Specifications
  • Scope & content
  • Concept (proposal)
  • Defect classes and selected test procedures (Example)
Shelf-life of Packaging Components
  • Why is a defined shelf-life required?
  • How to define the shelf-life for packaging components?
  • Re-Testing of packaging components
Q&A Session 1
 
 
Day 2 - 28 November 2024
 
Qualification of Analytical Instruments used for Packaging Control
  • Important points for qualification (IQ/OQ/PQ)
  • Software validation
  • Examples (e.g. tensile testing)
Control of Primary Packaging Materials - Examples for Pouches and Blisters
  • Overview of the development / production of pouches / blisters
  • Control of process parameters / products during production (IPC)
  • Control of final products
Supplier Management
  • Applicable GMP standards for packaging suppliers
  • Selection of suppliers
  • Technical agreements, supplier qualification and audits
  • Continuous supplier evaluation
Q&A Session 2
 
Risk Based Inspections of Packaging Materials
  • How to set up a control system for packaging materials
  • Practical application of FMEA
  • What, why, and how to test
  • Strategies for reduced testing
Case Study on Reduced Testing / Reduced Sampling
  • Inspection Procedures for Primary and Secondary Packaging Materials
Q&A Session 3

stop

This course is part of the GMP Certification Programme "ECA Certified Packaging Manager" Learn more

ECA-Member*: € 1390,-
Non ECA Member*: € 1590,-
EU/GMP Inspectorates*: € 795,-
APIC Member Discount*: € 1490,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023