| 1 | Manufacturing Standards and GMP Status | Confirm that the finished dosage form is manufactured in a facility operating under applicable pharmaceutical Good Manufacturing Practice requirements. | Current GMP certificate or regulatory inspection outcome; manufacturing-site scope; approved product and process documentation. | The certificate should cover sterile pharmaceutical production and remain valid for the proposed manufacturing site. | Expired certificate, unclear site ownership, or incomplete inspection records. |
| 2 | Sterility Assurance and Aseptic Controls | Evaluate the controls used for sterile filling, lyophilization or powder processing, environmental monitoring, personnel qualification, and contamination prevention. | Validated aseptic-process procedures; cleanroom classification data; environmental-monitoring trends; media-fill results; sterility-test records. | Sterility testing should follow the applicable pharmacopoeial method, supported by validated processes and documented contamination-control strategy. | Reliance on final sterility testing alone or missing media-fill and environmental-monitoring data. |
| 3 | Identity, Assay, and Related Substances | Check whether the supplier can consistently confirm amoxicillin sodium identity, potency, degradation profile, and compliance with the approved specification. | Representative certificates of analysis; validated or verified analytical methods; reference-standard controls; batch-release results. | Results should comply with the applicable registered specification or pharmacopoeial monograph for every released batch. | Unexplained potency variation, incomplete impurity data, or certificates without test methods and acceptance criteria. |
| 4 | Bacterial Endotoxins and Particulate Control | Review controls for bacterial endotoxins, visible particles, and subvisible particulate matter in the final sterile product. | Endotoxin test results; visible-particle inspection records; subvisible-particle data where applicable; depyrogenation validation. | Testing should use a suitable validated method and meet the endotoxin and particulate limits applicable to the product, route, and maximum labeled dose. | Repeated borderline results, unexplained atypical trends, or no documented investigation of particle findings. |
| 5 | Container-Closure Integrity and Packaging | Assess whether the vial, stopper, seal, label, and secondary packaging protect the sterile powder throughout storage and transport. | Container-closure integrity studies; component qualification; extractables and leachables assessment where relevant; packaging-line controls. | The complete container-closure system should be qualified for the labeled shelf life and distribution conditions. | No integrity testing, inconsistent component specifications, or packaging that does not protect against moisture and contamination. |
| 6 | Product Consistency and Stability | Determine whether multiple production batches show stable quality and whether the proposed shelf life is supported by stability data. | Trend reports for at least three representative batches where available; accelerated and long-term stability studies; reconstitution and compatibility data. | No adverse trends in assay, degradation products, appearance, moisture, sterility-related attributes, or reconstituted-solution performance during the labeled shelf life. | Large batch-to-batch differences, frequent out-of-trend results, or shelf life unsupported by adequate stability studies. |
| 7 | Quality Systems, Supply Continuity, and Technical Support | Review deviation management, change control, complaint handling, recall readiness, batch traceability, and the supplier’s ability to maintain supply. | Quality agreement; change-notification procedure; CAPA records; recall simulation results; supply-history data; lead-time and minimum-order information. | Written procedures should define notification timelines, traceability from raw materials to finished batches, and documented corrective-action effectiveness checks. | Unclear change-notification duties, weak traceability, unresolved complaints, or repeated unexplained delivery disruptions. |