Reduced Sampling / Reduced Testing AND Quality of Nasal and Inhalation Drug Products

Reduced Sampling / Reduced Testing AND Quality of Nasal and Inhalation Drug Products

Berlin, Germany

Course No 15911


Costs

This conference already took place.

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

Speakers

Reduced Sampling / Reduced Testing

Emerich Grassinger, Aenova Group - Haupt Pharma Wülfing GmbH, Germany

Dr Matthias Heuermann, NRW Centre for Health (LZG.NRW), Germany

Dr Gerald Kindermann, F. Hoffmann-La Roche, Switzerland

Dr Michael Möhlen, Valneva Austria GmbH, Austria

Dr Bernd Renger, Bernd Renger Consulting, Germany

Dr Martin Wesch, Wesch & Buchenroth, Law Office, Germany


Quality of Nasal and Inhalation Drug Products

Dr Carol Barbour, UK

Dr Manfred Fischer, Skyepharma (member of Vectura group), Switzerland

Dr Armin Hauk, Sartorius Stedim Biotech GmbH, Germany

Dr Rudi Müller-Walz, Skyepharma (member of Vectura group), Switzerland

Mark Parry, Intertek Melbourn, UK

Objectives

Reduced Sampling / Reduced Testing
The aim of this course is to demonstrate the process of the qualification of starting materials (APIs and excipients) and packaging materials (primary and secondary) and to define the prerequisites for implementing a system for reduced sampling and reduced testing for these products. This system has to be in compliance with the actual GMP requirements in Europe and in the US, though. Case Studies will show how to define and optimise sampling and testing procedures and you will discuss further details in a parallel session with 3 workshops.

Quality of Nasal and Inhalation Drug Products
This GMP Education Course on Nasal and Inhalation Drug Products aims at providing delegates with a sound understanding and best practices in the development and analytical quality control of Metered Dose Inhaler (MDI), Dry Powder Inhaler (DPI) and Nasal Drug Products. The course provides a comprehensive overview of the regulatory requirements in Europe and U.S. (Ph.Eur., USP, FDA, and EM(E)A) and shows how all these requirements can be put into practice.

Background

Reduced Sampling / Reduced Testing
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.

Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the necessary tests are conducted on the incoming goods and that the materials are released only after their quality was judged as satisfactory.

According to the revised Chapter 5 – Production – of the EU GMP Guide in operation since 1 March 2015, the selection, qualification, approval and maintenance of suppliers has to be documented and the level of control has to be proportionate to the potential risks posed by the individual materials. Manufacturers of medicinal products are responsible for testing the starting and packaging materials as described in the marketing authorisation dossier. However, it is explicitly accepted to outsource these testing activities, if the following requirements are fulfilled:

b) Audits performed at appropriate intervals at the sites carrying out the testing

c) A certificate of analysis signed by a designated person with appropriate qualifications and experience

d) Significant experience in dealing with the starting material manufacturer (“history of compliance”)

e) Full analyses that are performed regularly by the medicinal product manufacturer to compare the results with the supplier’s certificate of analysis.

It is the aim of this GMP Education Course to show how these requirements can be put into practice.

Other focus areas of this course are the regulatory requirements for sampling, the design and qualification of sampling areas and the handling of varying specifications in the different pharmacopoeias for identical APIs and excipients used for finished drug products dedicated for the markets in Europe, in the US, and in Japan.
Must different tests be conducted according to EP, USP, and JP, respectively?

The course programme will be completed by a lawyer’s presentation about the legal and contractual liability of suppliers for defect products

Quality of Nasal and Inhalation Drug Products
The market for Oral Inhalation and Nasal Drug Products (OINDPs) has become increasingly important and at the same time the number of requirements from regulatory authorities have increased.

Key guidance documents and relevant pharmacopoeial General Chapters are:

FDA Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI), EM(E)A: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products,
Ph.Eur. 2.9.18, Preparations for Inhalation (Inhalanda), USP <601> Inhalation and Nasal Drug Products: Aerosols, Sprays and Powders-Performance Quality Tests.

Pharmaceutical development based on Quality by Design (QbD) principles is key to achieve inhalation drug products of high reproducible performance. Extensive characterisation of the drug substance and drug product batches is necessary to qualify an inhalation drug product for its intended use - the delivery of the drug substance into the lungs.

Challenging issues in the development and control of inhalation drug products are:

  • Physical characterisation of starting materials
  • Control of extractables and leachables
  • Reproducibility of the delivered dose
  • Constant particle size distribution throughout shelf-life
  • Patient friendly performance characteristics of the drug produc
t
The objective of this course is to cover all aspects of development and analytical testing of Inhalation and Nasal Drug Products with a focus on practical examples.

Workshops are an essential part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussion of the subject.

Target Group

Reduced Sampling / Reduced Testing
This GMP Education Course is directed at all those employees from quality control units in the pharmaceutical industry (including heads of quality control and laboratory managers) who are competent or responsible for sampling, testing and release of starting materials (APIs and excipients) and packaging materials (primary and secondary). This course is also of interest to personnel from quality assurance and to those employees from API, excipient or packaging material suppliers who want to inform themselves about the requirements of the pharmaceutical industry on the testing of these materials.

Quality of Nasal and Inhalation Drug Products
This course is dedicated to scientists and managers in the pharmaceutical industry working in

Quality control
Quality assurance
Analytical development
Formulation and process development
Regulatory Affairs

The course is also intended for participants from contract laboratories, regulatory authorities, and inspectorates.

Programme

Reduced Sampling / Reduced Testing

Regulatory Requirements for Sampling Procedures

  • API and finished goods sampling
  • Regulatory requirements: EU GMP Part 1, Chapters 4, 5, 6 / EU GMP Part 2, Chapter 7 / EU GMP Annex 8 / EU GMP Annex 19
  • Other regulations: US / FDA Requirements / WHO - PIC/S - ISO (former Military Standard)
  • Supplier qualification and audits: Reduced testing
Design and Qualification of Sampling Areas for Incoming Goods Products
  • Sampling area for raw materials, APIs and excipients
  • Layout and design of premises and equipment
  • “Cleanroom”-like classification?
  • What are the appropriate environmental requirements for sampling areas?
  • How to qualify and maintain sampling areas?
  • Is a change of pallets/removal of cart boxes required?
  • Are expectations increasing? - Lessons learned during inspections
Supplier Qualification and Supply Chain Traceability: an important Prerequisite for Reduced Sampling and Reduced Testing
  • Prerequisites
  • Qualification of packaging materials
  • Qualification of APIs and excipients
  • Supplier qualification / Supplier audits
  • Quality Agreements
  • Specifications / Pharmacopoeial monographs /
  • Supplier CoA
  • Complaint Handling
Sampling and Documentation to make the Supplier liable for Defect Products
  • Legal and Contractual Liability
  • Definition of a Product Defect
  • Express Warranty
  • Admissible Evidence
  • Insurability
Case Study I: How to Define Inspection Procedures for Packaging Materials (Primary and Secondary) in the Incoming Goods Control
  • Sampling Plans for printed packaging materials, glass containers, plastic containers, etc.
  • AQL (Acceptable Quality Level)
  • Tests required according to Ph.Eur. / USP
  • Options for reduced sampling
  • Options for reduced testing
  • Skip lot testing
Case Study II: How to Define and Optimise Sampling and Testing Procedures for APIs and Excipients in the Incoming Goods Control
  • Sampling Plans for APIs / excipients
  • Verification of pharmacopoeial procedures
  • Options for reduced sampling
  • Options for reducing analytical costs
  • Use of / NIR / Raman for an efficient control
How to Deal with Divergent Compendial Method Requirements
  • ICH QB4 and the Pharmacopoeial Discussion Group
  • Divergent and conflicting pharmacopoeial requirements
  • CDER’s MAPP 5310.7 “Acceptability of Standards from Alternative Compendia”
  • How to proceed in case of missing harmonization?
  • How to proof equivalence?

Parallel Sessions: Working on specific Tasks


1. Strategies/Prerequisites for Reduced Testing / Reduced Sampling
The aim of this workshop is to evaluate in small discussion groups how the opportunities and requirements of EU GMP Annex 8 and 21 CFR Part 211 should be implemented in QA / QC.

2. Reduced Testing / Reduced Sampling for APIs / Excipients
Participants will discuss and calculate benefits of different measures in small groups. Scenarios of different materials / suppliers / qualification status, use of NIR/RAMAN for identity testing and optimization of the order size to reduce testing effort will be evaluated including their impact on the sampling and testing plans for APIs and excipients.

3. Reduced Testing / Reduced Sampling for Primary and Secondary Packaging Materials
Participants will discuss in small groups scenarios of different materials / suppliers / qualification status / etc. and their impact on the sampling and testing plans with regard to reduced sampling and reduced testing for packaging.

You will be able to attend 2 of these parallel sessions. Please choose the ones you would like to attend when you register for this Course.

Quality of Nasal and Inhalation Drug Products

Regulatory Requirements for Respiratory Drugs
  • Pharmacopoeia requirements: USP <601> Aerosols, Nasal Sprays, Metered Dose Inhalers, and Dry Powder Inhalers, Ph.Eur., Preparation of Inhalation (Inhalanda), 2.9.18 Preparation for Inhalations
  • Guidance documents: EM(E)A: Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products, FDA: Draft Guidance for Industry: Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products
  • Specifications for raw materials (APIs and excipients) and components for container closure system (valves, canisters, actuators)
  • Analytical test methods and specifications for the drug product, U.S. vs. EU
  • Product characterization studies
  • Finished product stability
Good Development Practices for Inhalation Drug Products
  • Evolution of regulatory framework
  • Guidelines on combination drug products
  • Quality by Design in inhalation drug product development
  • Container closure systems for MDIs
Development of Modern Nasal Drug Products
  • Formulation and technologies
  • Regulatory considerations
  • Differences to inhalation products
Dose Content Uniformity Test – a Key Method to Characterize Inhalation Drugs
  • Basics of the method according to USP <601> and Ph.Eur. Inhalanda
  • Challenges in sample preparation: MDIs, DPIs
  • Testing design and specifications: U.S. vs. EU
  • Additional requirements of EM(E)A and FDA guidelines
  • What is the future for DCU method: Zero tolerance vs. parametric tolerance interval test
Particle Size Distribution and Determination
  • Current test requirements (USP <601> and Ph. Eur. Inhalanda)
  • Key aspects of testing (concentrating on ACI and NGI)
  • Proposed future developments
Nasal and Nebulizer Testing
  • Requirements for product and performance quality tests
  • Discussion of the types of testing required from USP <5> and <601>
  • Specific requirements for nebulisers (EP 2.9.44)
Requirements for Starting Materials for Inhalation and Nasal Drug Products
  • Drug substance requirements and characteristics
  • Engineered drug particles
  • Functional excipients for inhalation drug products
  • Excipients for nebulized and nasal formulations
New Testing for Spacer Devices
  • Types of spacer device
  • Potential challenges with spacers
  • Testing required to characterise performance
Requirements for Devices and Delivery Systems
  • Inhaler devices and device components
  • Nebuliser technologies
  • Device development and medical device aspects
  • Device functionality and patient usability
  • Basics on Human Factor Engineering
  • Formulation of Biologics for Inhaled and Nasal Drug Products
Regulatory Strategy for the Global Respiratory Market
  • The respiratory market – A global view
  • Development of OINDPs for the global market in a fragmented regulatory environment
  • Aspects for a common world-wide regulatory strategy
Extractables / Leachables Assessment for MDI and DPI Devices
  • The relevance of extractables and leachables testing for MDI and DPI
  • The strategy for E & L testing for MDI and DPI
  • Illustrative examples from E & L investigations on MDI and DPI
  • The evaluation and assessment of E & L data
Development of Generic and Line Extension Products
  • General requirements for generic OIPs
  • In-vitro equivalence of the o

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK