Pharmaceutical technology Europe, 2019-10-01, Vol.31 (10), p.58-60
Pharmaceutical Technology Europe spoke with Bhroma Patel, head of product stability, and Baldev Jogi, lead scientist, both at Lonza; and Will Hatcher, senior manager, QC, and Rekha Patel, director, biologics analytical solutions, both at Catalent, about what steps companies need to take when setting up a current good manufacturing practice (CGMP)-compliant stability testing programme for biologics. A stability programme should be described in the protocol to support the shelf life and storage condition and include: * Objective/scope of the study (e.g., the stability study results may form part of submissions to the regulatory authorities to support the use of the product in toxicological studies and clinical trials). * Storage conditions (e.g., intended, accelerated, and stress storage conditions) * Sampling plan (e.g., samples to be tested at 0, 3, 6, 9, 12, 18, 24, and 36 months) * Stability indicating parameters for testing of product characteristics, identity, potency, purity, and safety, which have been developed and validated * Stability test methods (e.g., capillary electrophorsis sodium dodecyl sulfate [CE SDS], image capillary isoelectric focusing [icIEF], gel permeation chromatography [GPC], ELISA), which have been qualified for usage * Acceptance criteria (e.g., limits for the test results) * Reference standard to compare the sample against * Approval process (e.g., approved by quality assurance [QA]) * Stability chambers are serviced, inspected, calibrated, and qualified regularly * Out-of-specification and out-of-trend SOPs QA regulated * Evaluation of the acquired data to provide a shelf life * Trained operators, which includes GMP training and data integrity training annual. [...]a strong track record of quality compliance and experience working with regulatory bodies in different jurisdictions is also paramount. [...]the site's regulatory history should be reviewed to confirm that the site has received approval from all relevant regulatory agencies.
Studies ; Biological products ; Compliance ; Laboratories ; Good Manufacturing Practice ; Clinical trials ; FDA approval ; Outsourcing ; Cost control
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