What is validation, Qualifications and what is GMP, which role in pharma process.what is deviation.
Supports raw material qualification and speeds up drug filing preparation.
In line with CTD chapter 3 quality (adapted for excipients)
- General information
- Manufacturer
- Characterization (incl. regulatory declarations: BSE/TSE, melamine, nitrosamine, etc.)
- Control of drug substance
- Reference standard
- Materials
- Container closure system
- Stability summary
Free of charge*
Quality Management Dossier
Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
- Supply chain information
- Product quality self-assessment**
- Audit report summary
- Stability data***
5.500 €
Operational Excellence Dossier
- Elemental impurities information
- Product quality report
- Analytical procedure
- Technically Unavoidable Particle Profile (if applicable)
3.500 €
- General Information
- Manufacture
- Specification
- Regulatory Certificates
- Product Quality Self Assessment
- Packaging Information
- Stability Summary and Conclusion
Free of charge
* The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
** Based on Rx-360 SAQ Module 3
*** Available for Emprove® Essential and Emprove® Expert products only, based on long-term stability studies according ICH Q1A requirements.
Supports raw material qualification and speeds up drug filing preparation.
In line with CTD chapter 3 quality (adapted for excipients)
- General information
- Manufacturer
- Characterization (incl. regulatory declarations: BSE/TSE, melamine, nitrosamine, etc.)
- Control of drug substance
- Reference standard
- Materials
- Container closure system
- Stability summary
Free of charge*
Quality Management Dossier
Answers questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
- Supply chain information
- Product quality self-assessment**
- Audit report summary
- Stability data***
5.500 €
Operational Excellence Dossier
- Elemental impurities information
- Product quality report
- Analytical procedure
- Technically Unavoidable Particle Profile (if applicable)
3.500 €
- General Information
- Manufacture
- Specification
- Regulatory Certificates
- Product Quality Self Assessment
- Packaging Information
- Stability Summary and Conclusion
Free of charge
* The Material Qualification Dossier is free of charge and available on the specific product detail pages of our website after log-in. It can also be downloaded through the Emprove® Suite.
** Based on Rx-360 SAQ Module 3
*** Available for Emprove® Essential and Emprove® Expert products only, based on long-term stability studies according ICH Q1A requirements.
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