GMP meets Development GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

GMP meets Development

Hamburg, Germany

Course No 21365

This course is part of the GMP Certification Programme "ECA Certified Pharmaceutical Development Manager". Learn more.

Note: All times mentioned are CET.

Our Service

Costs

ECA-Member*: EUR 2090,--
Non ECA Member*: EUR 2290,--
EU/GMP Inspectorates*: EUR 1145,--
APIC Member Discount*: EUR 2190,--

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

Registration
* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr. Joachim Ermer, Ermer Quality Consulting
Sigrid Guhr, formerly AbbVie
Dr. Sue Mann, Sue Mann Consultancy
Katja Kotter, Vetter Pharma-Fertigung
Dr. Ulrich Kissel, European QP Association (EQPA), KisselPharmaConsulting

Objectives

During this Course, specialists will share their expert knowledge about all important GMP aspects in Pharmaceutical Development and Investigational Medicinal Product (IMP) Manufacturing. You will be able to elaborate and discuss both EU and FDA requirements.

Background

Not only in the manufacturing of marketed products (c)GMP Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And what is the role of ICH Q8, Q9, Q10 and Q12?

With the third revision of ICH E6 (ICH E6(R3)), the GMP for IMP principles will be expanded to the following: Adequate measures to ensure that the investigational product is handled and shipped appropriately should be implemented.

Previously, the WHO already published two documents relating to Development and GMP for IMPs: „Good Practices for Research and Development Facilities of Pharmaceutical Products” and „GMP for IMPs“.

In addition, instead of the current EU GMP Annex 13 (Manufacture of IMPs), the Detailed Commission guidelines on GMP for IMPs for human use apply.

Complex challenges have to be faced and resolved to guarantee high quality products. The safety of the drug and hence also the patient should always be the main focus. Terminated studies or studies without reliable results will lead to extensive extra costs and delays in the whole development and approval process.

This course has been designed by the ECA to broaden your knowledge and to consolidate the various GMP aspects which need to be considered in a successful development of a new pharmaceutical product.

Target Group

This course has been designed for R&D personnel involved in Pharmaceutical Development, IMP Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs.

Programme

Global GMP Requirements from Phase 1 to Scale-up and Transfer
  • Global requirements: applicable law, directives, guides and guidelines: what is really required
  • A comparison of FDA and European requirements and expectations
IMPs in the Context of ICH Q8-Q10, Q12 and Q14
  • How to integrate Quality by Design (QbD)
  • Risk Analysis in Pharmaceutical development
  • Life cycle concept
Important Documents in Pharmaceutical Development
  • Early documentation
  • CTD
  • PSF: style and Content
  • Case studies
Analytical Development (ICH Q14)
  • From method development to method validation
  • Quality control and IMP release
  • Analytical Qualification
Packaging and Supply of Clinical Trial Materials
  • GMP requirements
  • Quality control of packaging and labelling
  • Handling and sourcing of comparators
  • Randomisation and blinding
How to handle Deviations in an R&D Environment
  • Why we need a process for Deviations
  • What we need to know
  • How to do it
Change Control for IMPs
  • What is required
  • What is important
  • What are the benefits
  • How to implement
IMP Manufacturing: How much Qualification and Validation is needed?
  • Qualification vs. Validation
  • What can be found in the regulations
  • DQ/IQ/OQ of equipment
  • How much process validation is needed?
Cleaning Validation / Verification in Pharmaceutical Development
  • Cleaning validation vs. cleaning verification
The FDA Pre-Approval Inspection (PAI)
  • Involvement of the R&D Department
  • What the FDA will look for
  • What happens at FDA during and after the PAI
  • Responding to FDA after the PAI
The Role of the QP in Pharmaceutical Development and IMP Release
  • Responsibilities
  • Co-operation with Head of Production and Head of Quality Control
  • Confirmation of Compliance, certification and batch release
  • Comparators
  • Complaints and recalls
The GMP/GDP/GCP Interface
  • Reconstitution
  • Pre-requisites for randomisation and blinding
  • Distribution
  • Site-to-site Transfers
  • Shelf life extension
  • The QP: where does the responsibility end?

Interactive Sessions

1. Transition of GMP Requirements from Phase 1 to Phase 3 and the Interface to Development Work
  • Challenges and Differences
  • How to apply phase appropriate GMPs
  • Managing a GMP Lifecycle
2. Stability Studies throughout the Development of a new Product
  • Different types of products in CT studies (and support)
  • APIs and various dosage forms
  • Late stage stability strategies
3. Data Integrity
  • Manufacturer‘s understanding of data integrity, needs and benefit
  • Regulatory expectations
  • Hybrid systems (paper and electronic records) - how to ensure data integrity?
You will be able to attend 2 of these parallel sessions. Please choose the ones you like to attend when you register for the course.

Go back

GMP Conferences by Topics