References_Page_Solid_Dosage_ScaleUp.docx

T

1. References
1. U.S. Food and Drug Administration (FDA). SUPAC-IR: Scale-Up and Postapproval Changes for
Immediate Release Solid Oral Dosage Forms. Available at: https://www.fda.gov
2. International Council for Harmonisation (ICH). Q6A: Specifications – Test Procedures and
Acceptance Criteria for New Drug Substances and New Drug Products. Available at:
https://www.ich.org
3. International Council for Harmonisation (ICH). Q8(R2): Pharmaceutical Development.
Available at: https://www.ich.org
4. International Council for Harmonisation (ICH). Q9: Quality Risk Management. Available at:
https://www.ich.org
5. International Council for Harmonisation (ICH). Q10: Pharmaceutical Quality System.
Available at: https://www.ich.org
6. European Medicines Agency (EMA). Guideline on Manufacture of the Finished Dosage Form.
Available at: https://www.ema.europa.eu
7. U.S. Food and Drug Administration (FDA). Process Validation: General Principles and
Practices (2011). Available at: https://www.fda.gov
8. European Medicines Agency (EMA). Guideline on Process Validation for Finished Products –
Information and Data to be Provided in Regulatory Submissions (Revision 1). Available at:
https://www.ema.europa.eu
9. Peer-reviewed publications on pharmaceutical scale-up practices and Quality by Design (QbD)
approaches.