GMP Inspections: Do you know IRIS?
Register now for ECA's GMP Newsletter
IRIS is an online platform for handling product-related scientific and regulatory procedures with the EMA. In 2018, it was established in a first step for orphan drug procedures. It was then expanded step by step. The aim is to shorten the time of applications within the framework of scientific procedures.
In the meantime, there are a number of different instructions for use and an IRIS stakeholder forum where users (primarily applicants) can find out about news (e.g. new IRIS functions, version information). It allows asking questions, submitting proposals and further discussions.
As it expands, the platform will also be used by marketing authorisation holders and applicants to communicate with the EMA about GMP inspections.
There are a lot of links to further information on the IRIS website:
- Access & submission
- Public registers & lists
- Guidance & support
- News
Related GMP News
01/12/2021
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others