Material Management and the Impact on Extractables and Leachables

According to this guidance (1), these changes might require post-approval in accordance with section 506A of the US Federal Food, Drug, and Cosmetic Act and Code of Federal Regulations (CFR) Title 21 S.314.70 (21 CFR 314.70) (2). [...]FDA states that a major change has "a substantial potential...

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Bibliographic Details
Published inPharmaceutical technology Europe Vol. 34; no. 7; pp. 21 - 28
Main Author Feilden, Andrew
Format Journal Article
LanguageEnglish
Published Monmouth Junction MultiMedia Healthcare Inc 01.07.2022
Subjects
Aerosols
Biological products
Cell growth
CFR
FDA approval
Manufacturers
Manufacturing
Patient safety
Peptides
Pharmaceutical industry
Product quality
Product recalls
United States > US
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Summary:According to this guidance (1), these changes might require post-approval in accordance with section 506A of the US Federal Food, Drug, and Cosmetic Act and Code of Federal Regulations (CFR) Title 21 S.314.70 (21 CFR 314.70) (2). [...]FDA states that a major change has "a substantial potential to have an adverse effect on the identity, strength, quality, purity or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product" (1). [...]the drug product formulation was changed to include polysorbate 80; and secondly, the coated stopper was replaced with an uncoated one (3). In the early days of E&L testing, prior to appropriate change management, a change in the composition of the material was first known upon a test being conducted and a new extractable profile-or worse, a leachable profile was observed. Because leachables typically take time to form, this observation implied that a change happened, potentially, many months prior.
ISSN:1753-7967