New Q&As on Chapter 4 and 5 of the EU-GDP Guidelines
Register now for ECA's GMP Newsletter
On the GDP Association Website a section was set up a while ago dealing with frequently asked questions (FAQs). Now a set of new FAQs has been published on Chapter 4 (Documentation) and Chapter 5 (Operations).
For example, the following questions are discussed:
- Who authors documents? Who needs to approve them?
- In which language should documents be written?
- Is it allowed to print procedures from an electronic system?
- How can I check if a supplier has an appropriate legal authorisation?
- Besides temperature, are there other environmental factors which might harm medicinal products?
- Why do I need to qualify customers?
Answers to these and other questions are provided in the new FAQs on GDP.
Related GMP News
01/06/2021
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