Material Management and the Impact on Extractables and Leachables

• Published in: Pharmaceutical technology Europe Vol. 34; no. 7; pp. 21 - 28
• Main Author: Feilden, Andrew
• Format: Journal Article
• Language: English
• 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
• ISSN: 1753-7967

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.