1Aseptic processing and sterility assurance
Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed.
Inspection Record
Daewoong Pharmaceutical Co. Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures: Aseptic processing, which includes as appropriate: A system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Process validation
Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance.
4Training and personnel
Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.
5Material and supplier control
Production operations should be conducted in a manner that will prevent contamination of intermediates or APIs by other materials.
6Computer system validation
Appropriate controls should be exercised over computer systems to assure that changes to records are instituted only by authorized personnel.
7Material and supplier control
Materials should be handled and stored in a manner to prevent degradation, contamination and cross- contamination.
About this record
Extracted automatically from the document US FDA published on 2018-01-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
