1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterlization process.Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterlization process.Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterlization process.
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
3Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
4Other quality system
Clothing ofperwnnel engaged in tbe manufacturing, proeessing.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to detennine conformance to such requirements.
6Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable fur their intended use.
7Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactor y conformance to a the final specifiction and identify and strength of each active ingredient prior to release.
8Equipment and facility
Buildings used .in rrns manufacture, processing, packing, or holding of a drug product do not have the suitable construction and location to facilitate cleaning, maintenance, and proper operations.
9Other quality system
Procedures describing the caligration of instructions, apparatus, gauges, and recording devicces are not written or followed.
10Material and supplier control
Each lot ofcomponents, drug product containers, aud closmes is not withheld from use until the Jot has been sampled.
