What do I need a Toxicologist for in the GMPs

Working on a job description for a toxicologist. Here’s what I have so far: what am I missing on the GMP side (not the GCP, GVP, or GLP sides).

A toxicologist plays several important roles in GMP activities, including in cleaning validation and extractable/leachable (E&L) studies for pharmaceutical manufacturing:

For cleaning validation:

1. Establishing safety thresholds: Toxicologists help determine the Permitted Daily Exposure (PDE) or Acceptable Daily Exposure (ADE) limits for residual substances. These limits are crucial for setting acceptance criteria in cleaning validation.
2. Risk assessment: They evaluate the potential health risks associated with residual substances that may remain after cleaning processes.
3. Determining safety factors: Toxicologists apply appropriate safety factors when calculating acceptable residue limits, considering factors like route of administration and patient population.
4. Reviewing toxicological data: They analyze available toxicity data on active ingredients, excipients, and cleaning agents to inform safety assessments.

For extractable and leachable studies:

1. Toxicological evaluation: Toxicologists assess the potential health impacts of identified extractables and leachables from packaging materials or manufacturing equipment.
2. Setting thresholds: They help establish Safety Concern Thresholds (SCT) and Analytical Evaluation Thresholds (AET) for E&L studies.
3. Risk characterization: Toxicologists evaluate the toxicological significance of detected leachables in relation to patient exposure.
4. Providing expertise on regulatory guidelines: They ensure studies comply with regulatory expectations regarding toxicological risk assessment.
5. Interpreting study results: Toxicologists help interpret the significance of E&L findings in the context of patient safety.

Toxicologists provide critical expertise in assessing the potential health impacts of trace contaminants or leached substances. They also ensure that cleaning processes and packaging materials do not introduce unacceptable risks to patient safety. Their input is essential for developing scientifically sound and regulatorily compliant approaches to these critical pharmaceutical quality and safety aspects.