Good documentation Practices

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Your QC Microbiology laboratory has no equipment usage logbook or any other document that records incubator usage details for a

19/04/2024

Microbiology FDA 483 (Eugia SEZ): Failure to maintain a backup file of data entered into the computer or related system

*** Nonviable Particle Counters, Model Number, 3423, Equipment ID No. PR-NVPCP-001, PRNWCP-002, PR-NVPCP-004, lack the functionality to save data internally

22/03/2024

Microbiology FDA 483 (Panacea Biotec): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Smoke studies are inadequate in that they do not demonstrate unidirectional air flow in the following instances

09/03/2024

Microbiology FDA 483 (Panacea Biotec): Procedures designed to prevent microbiological contamination for are not established, written and followed (Sterile Drug)

Viewing of the aseptic filling area is only available through real time and previously recorded videos. During this inspection reviewed

08/03/2024

Microbiology FDA 483 (Sun Pharmaceutical): The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed

Microbiology FDA 483 (Eugia SEZ): Failure to maintain a backup file of data entered into the computer or related system

Microbiology FDA 483 (Panacea Biotec): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Panacea Biotec): Procedures designed to prevent microbiological contamination for are not established, written and followed (Sterile Drug)

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Container closure systems do not provide adequate protection against foreseeable external factors

Microbiology FDA 483 (Jiangsu Hengrui Pharmceuticals): Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process

Microbiology FDA 483 (Jubilant Radiopharmacies): The movement of first air in the ISO 5 area is blocked or disrupted

Microbiology FDA 483 (Jubilant Radiopharmacies): Personnel were observed performing aseptic processing outside of an ISO 5 area

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for monitoring environmental conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions

Microbiology FDA 483 (Eugia Pharma Specialities): Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations

Microbiology FDA 483 (Eugia Pharma Specialities): There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination did not include adequate validation of the aseptic process

Microbiology FDA 483 (Eugia Pharma Specialities): Procedures to prevent microbiological contamination sterile drug product are not established and followed