Target Group
These training courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/fermentation), especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.
Objectives
These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advices will be given on how to fulfill the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10, Q11 and the ICH Q7 Q&A Document.
For example, you will learn
- at which stage of production GMP compliance is to be applied,
- how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, change control, failure investigation etc.,
- how to use a risk-based approach within the concept of supplier qualification,
- how to link material attributes and process parameters to drug substances CQAs,
- what has to be considered in order to be prepared for a GMP inspection.
Choose between two parallel GMP education courses according to your field of interest:
ICH Q7 Compliance for APIs manufactured by ChemicalSynthesis
or
ICH Q7 Compliance for APIs manufactured by CellCulture/Fermentation
Take advantage of combining one of the ICH Q7 Courses with the Auditor Training Course and receive the ECA Certifcate "QA Manager and Auditor for APIs".
The ICH Q7 Auditor Training Course will inform you about the general advice on Good Auditing Practices included in the APIC "Auditing Guide" and the APIC Third Party Audit Programme. In addition to the training of the communication skills, you will be provided with assistance on what to focus on during an API audit and on the current "state of the art" from an industry perspective. Moreover, you will learn about the key principles of writing a professional audit Report.
Programme
- Information on APIC
- Contribution to GMP Compliance and Supply Chain Integrity
- How to do Document
- Quality Agreements
- ASMF Guideline
- FMD and GDP for APIs
- ICH Q7 Q&A How to do Document
- Further activities
- What is ICH ?
- API related ICH Guidelines
- ICH Quality Guidelines
- ICH Q7 – Hot topics and requirements
- Overview of guidance documents (Q8 to Q14)
- Overview about the ICH Q7 Questions and Answers Document
- Some Highlights from the Q&A Document and their Interpretation
- Distribution procedures, intercontinental shipments
- Risk assessment and Validation
- Complaints and recalls - Interactive Session
- Overview: relevant guidelines
- Inspections in drug product facilities - relevant topics for API manufacturers
- Recent findings in inspections
- Experience with GMP inspections of API manufacturers
- Major findings/observations during inspections
- Do’s and Dont’s during inspections
- Common pitfalls and typical audit findings
- Top observations from inspections by European authorities
- Experiences made by FDA
- Recent statistics from FDA Warning Letters to API manufacturers
Compliance Session Part 2 – Production and QC Issues
GMP Inspections at Biotech Companies
- Special considerations for inspections at Biotech Companies
- Cell Banks Facility
- Biological Materials and Culture Media
- Fermentation
- Viral removal/inactivation
- Laboratories
- Recent regulatory findings
- Most common FDA audit observations
Instances of Virus Contamination in GMP manufactured Products – what can we learn?
- Virus contamination in GMP manufactured products (examples)
- How to implement continued vigilance with regard to potential virus contamination
- Virus contamination and root cause analysis
- Application of appropriate risk control measures
- Approaches to minimise the risk of contamination
Cleaning and Cleaning Validation in Biotech Manufacturing Processes
- Identification of cleaning mechanisms and selection of cleaning agents
- Selection of analytical methods for the detection of residues
- Establishment of limits in fermentation and downstream
- processing
- Grouping strategies
- Final rinse versus swab testing
Cellbanking –Master Cell Banks (MCB) and Working Cell Banks (WCB)
- Establishment of MCB and WCB
- Definition of ’API starting material’
- Cell Bank qualification and testing
- Cell Bank maintenance and record keeping
Specific Interactive Training Sessions
- Process validation for biotech manufacturing processes
- Cleaning Validation
- Principles of risk assessment from Cell Banks to viral safety
Supply Chain Life Cycle: Reduced Testing and Supplier Qualification
- ICH Q7 requirements
- Supplier qualification covering the full supply chain
- One strategy for supplier qualification from non-critical raw material to API
- Requirements and strategy for reduced testing (CoA release) of materials
- Drivers for Change
- The regulations´ view on changes
- The Importance of Change Control
- Elements of a Change Control System
- Roles & Responsibilities
- Detailed Requirements for Specific Changes
- Implementation of Changes
- Regulatory requirements
- „Five steps implementation strategy“
- How to handle CEP updates and new registrations from the perspective of the Marketing Authorisation Holder
- Which requirements are applicable to APIs under ICH Q7?
- Specific Requirements and Interpretations
- Consideration for specific risks
- The hubris of hybrid records
- Case study: how to achieve Data Integrity on a risk-based Approach
- Stability Specification
- Stability Studies
- Stability test methods
- Stress tests
- Packaging
- Guidance on API stability testing
Costs
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
This course is part of the GMP Certification Programme "ECA Certified API Production Manager"
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
