Annex 2 & Co. - GMP Compliance for Biopharmaceuticals Regulatory Requirements and Practical Implementation

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals

Heidelberg, Germany

Course No 20403

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



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Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Dr Markus Fido, MFi Bio-Consulting
Dr Matthias Leitritz, Rentschler Biopharma
Stephan Löw, CSL
Dr Daniel Müller, GMP Inspector, German Local Government
Friederike Wedelich, GMP Inspector, Local Government Tübingen


This Education Course concentrates on regulatory and practical requirements regarding biopharmaceutical production. From clinical phases to routine manufacturing, practical examples and case studies will facilitate the implementation of GMP in your daily business.

The course will treat the topics of routine inspection from regulatory bodies and customers, quality assurance and quality control as well as in laboratory and production.

Speakers from manufacturing, laboratory, consultancy and authority will show their expectations as well as their experiences in GMP implementation.


In defiance of all throwbacks in the last years, a progression of new approvals of biopharmaceuticals is expected.  Furthermore after the end of the protection of patents, biotechnical generics will be added.

Especially in the field of biotechnology you find particular challenges to fulfil the regulatory requirements on production and quality assurance.

Industry and authorities have to face the new and expected changes in the regulatory Guidelines.

Target Group

This course is advisable to people who
  • are involved in regulatory inspections,
  • work in quality units at biotech companies,
  • implement GMP in biotech production,
  • are responsible for GMP requirements pre-approval phases.


GMP Requirements Applying to Biotechnological Investigational Medicinal Products
(IMPs of Clinical Phases I-III & APIs for use in IMPs)
  • EU regulations & guidances
  • Examples of national  regulations
  • State-of-the-art  manufacturing for clinical phases
GMP Guidelines for Biopharmaceuticals – a Brief Summary
  • Relevant international  regulations
  • European biotech guidances
  • Recent developments & possible impacts
Development of Biopharmaceuticals – GMP, Regulatory Aspects and Inspection & Audit Experiences
  • EU and US guidances related to clinical trials GMP/CMC incl. Annex 13 update
  • CDMO considerations on specifications
  • Inspection and audit experiences “pre-approval”
Development, Qualification and Validation of Process Analytics for Biopharmaceuticals
  • Relevant guidelines
  • Phases of product development / testing requirements
  • Method portfolio/method development / method qualification / method validation
GMP Inspections in Biopharmaceutical Production
  • Inspections of biopharmaceutical companies
  • Focus & discussion points during inspections
    • Clean room classes for biotech facilities
    • Open vs. closed processing
    • Single- vs. multi-purpose equipment
    • Cell banking activities
  • Inspector’s experience, examples of observations
Process Transfer from Development to Commercial Production from a Quality Perspective
  • Definition and types of Transfers
  • Specific quality considerations for transfers
  • Transition from “development” to “commercial”
GMP-conform Process Development and Validation (incl. Equipment Qualification)
  • Introduction      
  • Current initiatives in pharmaceutical development
  • Biopharmaceuticals / Biosimilars / Biological
  1. Process
  2. Analytical Methods
  3. Equipment / Instruments and Facility
Quality Assurance for Biopharmaceuticals
  • Classical responsibilities of QA department
  • Allocation of responsibilities, training of staff
  • Dealing with suppliers & contractors
  • The world changes: Change Management
  • Shit happens: Deviation management  & CAPA
  • Handling complaints & product  recalls
  • Paper, paper, paper: documentation works: SOPs, MBR, PQR & management report
  • Surveillance of qualification & validation, calibration and  maintenance
  • Self inspections & auditing
Bioanalytics for Clinical Trials – Method/Process Development and Validation for Phase I – III Studies
  • Definitions of terms (ICH, Qs)
  • Process development & quality by design
  • Early clinical Phase
  • Late clinical phase
  • Post approval
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 1
  • Reasons for cell banking
  • Where does GMP start
  • Characterization of cell Banks
  • Storage of cell banks
State-of-the-art Biotechnological Manufacture (Bacteria, Yeast, Mammalian Cells) and Cell Banking Activities - Part 2
  • Overview of a typical biotech process
  • Requirements on production areas, raw materials and equipment
  • Specialities on biotech products
  • Fill and finish
mRNA Technology – Principles, Manufacturing and Regulatory Perspective
  • COVID vaccines: Viral and mRNA vaccines
  • Modular principle of mRNA-based vaccines and mRNA vaccine manufacturing
  • Regulatory perspective on mRNA products
  • Application process for updating the MIA
  • GMP challenges for new biological products
Prevention of Cross Contamination: Dedicated Manufacturing or Cleaning Validation?
  • Requirements of Chapter 3 and 5 and Annex 2
  • Decision with consequences: multipurpose Equipment or disposables
  • Dirt or product: the perspective defines contamination
  • Ways to remove contaminants: cleaning procedures and their testing
  • Risk-based approach: crucial element of the validation Programme

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