Which topic must be included in GLP SOPs?

Which topic must be included in GLP SOPs?

• A. Necropsy or postmortem examination of animals
• B. Animal feeding schedules
• C. Laboratory safety training for staff
• D. Receipt, ID, storage and mixing of test, control and reference substances

Answer: (D)

In GLP, ensuring proper management of test materials is essential for data integrity. The SOPs must specify how test, control, and reference substances are received, identified, stored, and mixed. This covers verifying lot numbers, confirming the substance matches its certificate of analysis, keeping storage conditions appropriate, and documenting every handling step so the study data can be traced back to the exact materials used. When these elements are clearly defined in GLP SOPs, it prevents mix-ups, contamination, or mislabeling that could compromise results or regulatory compliance. Other topics, like necropsy procedures, general animal feeding schedules, or staff safety training, are important for daily operations and welfare or safety, but they do not address the specific, regulated handling of study substances that GLP SOPs must mandate.

In GLP, ensuring proper management of test materials is essential for data integrity. The SOPs must specify how test, control, and reference substances are received, identified, stored, and mixed. This covers verifying lot numbers, confirming the substance matches its certificate of analysis, keeping storage conditions appropriate, and documenting every handling step so the study data can be traced back to the exact materials used. When these elements are clearly defined in GLP SOPs, it prevents mix-ups, contamination, or mislabeling that could compromise results or regulatory compliance.

Other topics, like necropsy procedures, general animal feeding schedules, or staff safety training, are important for daily operations and welfare or safety, but they do not address the specific, regulated handling of study substances that GLP SOPs must mandate.