Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V) - Pharmaceutical Technology

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Early Development GMPs for Small-Molecule Specifications: An Industry Perspective (Part V)
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development.


Pharmaceutical Technology
Volume 36, Issue 10, pp. 86-94

References

1. A. Eylath et al., Part I, Pharm. Technol. 36 (6) 54–58 (2012).

2. D. Chambers et al., Part II, Pharm. Technol. 36 (7) 76–84 (2012).

3. R. Creekmore et al., Part III, Pharm. Technol. 36 (8) 56–61 (2012).

4. B. Acken et al., Part IV, Pharm. Technol. 36 (9) 64–70 (2012).

5. P. Kurtulik, Pharm. Technol. 31 (4) 156–169 (2007).

6. ICH, Q6A Chemical Substances (ICH, Geneva, 1999).

7. L. Müller et al., Regul. Toxicol. Pharmacol. 44, 198–211 (2006).

8. ICH, S9 Nonclinical Eval. for Anticancer Pharm. (ICH, Geneva, 2009).

9. ICH Q3A(R2) Impurities in New Drug Substances (ICH, Geneva, 2006).

10. ICH Q3B(R2) Impurities in New Drug Products (ICH, Geneva, 2006).

11. ICH Q3C(R5) Impurities: Guideline for Residual Solvents (ICH, Geneva, 2011).

12. ICH, M7 Assess. and Control of DNA Reactive (Mutagenic) Impurities in Pharma. to Limit Poten. Carcin. Risk (Draft) (ICH, Geneva, 2012).

13. CHMP, Guideline on the Limits of Genotoxic Impurities (EMA, 2007).

14. CHMP, Guideline on the Spec. Limits for Resid.of Metal Catal. or Metal Reagents (EMA, 2008).


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