Understand ICH Q7 S4

What is the intent of the statement in [ICH Q7, 3.12] ‘training should be periodically assessed’? 

In [ICH Q7, 3.12], the statement ‘training should be periodically assessed’ refers to a system to evaluate if personnel remain proficient and competent in their job tasks and responsibilities, and whether more frequent, additional, or new training is needed and recurring training is up to date. 

Does ICH Q7 expect the use of a consultant and can a company delegate tasks and/or responsibility to a consultant?

ICH Q7 does not expect the use of a consultant. Consultants may perform delegated tasks and/or provide advice. However, the ultimate responsibility for API quality must not be delegated [ICH Q10 2.7, ICH Q7 2.2, 3.3]. 

When are dedicated production areas expected? 

ICH Q7 expects dedicated production areas for highly sensitizing materials such as penicillins and cephalosporins because of the patient risk (e.g., anaphylactic shock to penicillin-allergic patients) from trace amounts of these compounds in other medicines [ICH Q7, 4.40]. For materials of an infectious nature or high pharmacological activity or toxicity, a risk-based approach should be used to determine appropriate containment measures, which may include validated inactivation, cleaning and/or dedicated production areas [ICH Q7, 4.41]. While ICH Q7 does not define high pharmacological activity

or toxicity, these are generally determined by evaluating relevant animal and human data collected during research and development. Important considerations in this evaluation of pharmacological activity or toxicity may include Occupational Exposure Limit (OEL), Permitted Daily Exposure (PDE), Acceptable Daily Exposure (ADE), Threshold for Toxicological Concerns (TTC), No Observed Adverse Effect Level (NOAEL) [ICH S-guidelines, ICH E2E, 2.1.1], and the consequences of cross-contamination [ICH Q9, 4.3].