Phama Biotech Services
REMEDIATION OF QUALITY SYSTEMS
Strong and robust quality systems are required for companies to produce safe, high-quality products consistently and reliably. Not addressing concerns highlighted in FDA 483s and FDA warning letters in an effective manner may result in regulatory enforcement actions such as a pause in manufacturing, recall, import bans, detention, or product seizure.
To stay current regulatory authorities release guidance for the industry. In this area, QualiCulture provides expert services in creating, implementing, reviewing, and remediating quality systems.
The above schema covers the following elements in the pharmaceutical quality management system:
ONSITE REMEDIATION:
Quality systemLaboratory controlsFacilities and equipmentProduction systemPackaging and Labeling