Third-Party Audits: Ensuring That Excipients Meet cGMP Requirements

[...]party audits offer a way to reduce the cost of audits, both for the pharmaceutical manufacturer and the excipient supplier. Followup communications required Often, a third-party audit cannot cover all technical aspects. [...]certain proprietary or ad hoc issues or concerns should be addressed v...

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Bibliographic Details
Published in:Pharmaceutical Technology 2018-09, p.S8-S13
Main Authors: Klug, David B, Lindblad, Ralph D, Muse, Douglas G, Ulman, Katherine L, Walsh, Phyllis, Zawislak, Priscilla S
Format: Article
Language:English
Subjects:
Accreditation
ISO standards
Manufacturing
Medical equipment
Patient safety
Quality standards
Suppliers
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Summary:[...]party audits offer a way to reduce the cost of audits, both for the pharmaceutical manufacturer and the excipient supplier. Followup communications required Often, a third-party audit cannot cover all technical aspects. [...]certain proprietary or ad hoc issues or concerns should be addressed via followup (phone, email/mail, in-person, other) with the supplier after the audit and audit report. [...]an escalating number of second-party audits are being performed, globally, to justify quality and safety compliance of ingredients used in drug products. [...]party auditing and certification of excipient suppliers can assist in the development, manufacture, and supply of safe and effective medicinal products.
ISSN:1543-2521
2150-7376