The US FDA has issued Warning letter in month of July 2017 to an
Italian manufacturer of sterile products in Rome, due to deficiencies in the
design of the filling system as well as the testing for particulate matter.
The FDA inspectors noticed that below deficiencies…
1. Smoke studies in the
filling area showed turbulent airflow.
2. There's no testing of the
product for particulate matter before release.
3. Sterility testing
The FDA now expects the manufacturer to identify all possible
contamination risks in his aseptic production, including analyses of the
facility layout, personnel and material flow, air systems and ergonomics of the
equipment.
The FDA observations as below…
1. Your firm failed to use equipment in the
manufacture, processing, packing, or holding of drug products that is of
appropriate design, adequate size, and suitably located to facilitate
operations for its intended use and for its cleaning and maintenance (21 CFR
211.63).
2.
Your firm
failed to establish laboratory controls that include scientifically sound and
appropriate specifications, standards, sampling plans, and test procedures
designed to assure that components, drug product containers, closures,
in-process materials, labeling, and drug products conform to appropriate
standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
3. Sterility testing
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