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Crisis Management
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Management and Remediation

In instances such as where a Board of Health inspection has taken place and observations identified (e.g. 483, Warning Letter, Critical/Major Observations) Altos Pharma can provide technical and quality expertise to facilitate timely resolution and subsequently minimise event impact. Altos Pharma can also provide assistance when an event has been identified internally and immediate action is required.

Key activities in critical event remediation tend to include:
Immediately assess impact on product in the market, in the distribution network, or in inventory through a formalised Risk Assessment Process and as necessary performing a medical assessment of potential impact  on patient safety
Develop BOH Communication Strategy while meeting all reporting requirements e.g FDA Field Alert
Preparing a comprehensive investigation(s)
Batch disposition/ Recall (if applicable) strategy development

Instances where Altos Pharma personnel have provided support in similar instances have included:
Stability failure for assay & impurities within an ICH product stability program identified for marketed product
GMP deficiencies identified during GMP BOH inspection
483 and Warning Letter remediation for CMO manufacturing facilities and API suppliers

Solid dose, parenteral product and API found not to in compliance with respective product Marketing Authorisation (MA) and API Drug Master File (DMF)