E6: Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

Question 1

5.13 - Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

5.13.1

Answer 1

The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirement(s).

Question 2

Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

5.13.2

Answer 2

The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage conditions (e.g., protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any. The sponsor should inform all involved parties (e.g., monitors, investigators, pharmacists, storage managers) of these determinations.

Question 3

Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

5.13.3

Answer 3

The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during transport and storage.

Question 4

Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

5.13.4

Answer 4

In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.

Question 5

Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)

5.13.5

Answer 5

If significant formulation changes are made in the investigational or comparator product(s) during the course of clinical development, the results of any additional studies of the formulated product(s) (e.g., stability, dissolution rate, bioavailability) needed to assess whether these changes would significantly alter the pharmacokinetic profile of the product should be available prior to the use of the new formulation in clinical trials.