Certification
ICH-Compliant CDMOs
Compare CDMOs following ICH guidelines for pharmaceutical quality (Q series), analytical methods, stability testing, and impurity control.
1 company listed
About ICH Compliance
The International Council for Harmonisation (ICH) develops guidelines that harmonize pharmaceutical regulatory requirements across the US, EU, and Japan (the three founding regulatory regions). ICH guidelines cover quality (Q series), safety (S series), efficacy (E series), and multidisciplinary topics (M series). For CDMOs, the Q series is most directly relevant: Q7 (GMP for APIs), Q8 (pharmaceutical development), Q9 (quality risk management), Q10 (pharmaceutical quality system), Q11 (drug substance development), Q12 (lifecycle management).
ICH compliance is not a formal certification but rather adherence to internationally recognized guidelines. CDMOs that follow ICH guidelines produce documentation and data that are accepted by regulatory agencies worldwide, facilitating global filings. ICH Q7 GMP for APIs is particularly important -- it defines the minimum quality standards expected for active pharmaceutical ingredient manufacturing.
Frequently Asked Questions
What are the most important ICH guidelines for CDMOs?+
Key guidelines include: Q1 (stability testing), Q2 (analytical validation), Q3 (impurities), Q6 (specifications), Q7 (GMP for APIs), Q8 (pharmaceutical development/QbD), Q9 (quality risk management), Q10 (pharmaceutical quality system), Q11 (drug substance development), and Q12 (lifecycle management). CDMOs that follow these guidelines produce regulatory submissions accepted globally.
How does ICH compliance benefit sponsors?+
ICH compliance means the CDMO generates data and documentation in formats recognized by FDA, EMA, PMDA, and other ICH-member regulatory agencies. This eliminates the need for duplicative studies or reformatted documentation for different markets. It also signals that the CDMO understands international quality expectations and can support global regulatory strategies.
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