Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

IND PACKAGING INFORMATION REQUIREMENTS SHOULD BE DELETED

Executive Summary

IND PACKAGING INFORMATION REQUIREMENTS SHOULD BE DELETED from FDA's proposed guidelines on packaging materials, PMA maintained in May 1 comments to FDA. The assn. said that "in most cases, mfrs. do not have this information at the IND stage and do not send the information as part of the IND; it is submitted as part of the NDA. During Phase III the packaging may still be evolving and placing requirements for finalizing packaging at this stage could impede research on investigational new drugs." Because "the final packaging information must be part of the NDA submission," PMA declared, "the timing of their development should be decided by the sponsor. At a minimum we recommend that the information suggested be limited to that necessary to support the scope and duration of the proposed human testing." PMA also suggested that proposed surface/drug tests of container closures should be required only if there is contact between the drug and the cap. "Because closures are usually separated from the drug product by a liner, there is no interaction with the cap," the assn. maintained. Stating that "thus, the material composition of the cap is relatively unimportant," PMA also contended that "details relating to closure test, specifications, conditioning treatment, and cleaning are GMP considerations and should not be in the guideline." In addition, the assn. asserted that tests to determine migration of label adhesives through plastic container walls are unnecessary. "The length of time in which the adhesive in a liquid state is in contact with the container (minutes) is too short for any migration through the commonly used plastics," it said. PMA also noted that mfrs. frequently have not determined "the exact labeling system" at the time of an NDA submission and that under the draft guidelines, "changing adhesives or systems would be unnecessarily restrictive and time consuming as an NDA supplement would be required for each change." PMA further asserted that requirements for LVP (large volume parenteral) compatibility studies with a list of additive drugs for parenteral drug products in plastic containers should be dropped from the guidelines. "The requirement is related to the compatibility of the product in the LVP package with other additives," it said, "and as such is not a package-related concern, but a product-related concern." The assn. also contended that proposed test procedures for physiochemical and biological tests for plastic containers "not only go beyond current procedures and compendia but also perpetuate the use of the Draize test." PMA suggested: "To prevent unnecessary animal testing, reference to the sub-chronic mouse toxicity test and Draize eye irritation studies should be clearly stated to be exceptional circumstances rather than phrased in such a way to encourage future reviewers to demand these time-consuming, expensive and relatively low-information content tests." Criteria such as defect classification, sampling plans, acceptance specifications, and dimensional characters were also deemed by PMA to be unnecessary in the packaging guidelines because they are considerations covered by GMP regulations. "PMA recommends that the guidelines state that considerations covered by GMP regulations do not belong in an IND or NDA submission," it said. The assn. also advised that "the entire section on bulk containers . . . should be dropped because in-process storage is covered under GMPs."
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS006563

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel