IPEC Guidelines definition
Examples of IPEC Guidelines in a sentence
Durect shall maintain in Durect’s Facility and at any Second Site adequate and segregated holding accommodations for the Finished Excipients, Starter Materials, and Materials used in Manufacturing Finished Excipients in accordance with the Specifications, Regulatory Approvals, the Manufacturing Process, IPEC Guidelines and all other Applicable Law.
Such periodic audits will be limited to [* * *], and shall be conducted according to IPEC Guidelines.
Durect shall maintain Durect’s Facility and any Second Site and any related equipment in a state of repair and operating efficiency consistent with the requirements of the Specifications attached hereto as Exhibit B-1 and Exhibit B-2, Regulatory Approvals, the Manufacturing Processes, IPEC Guidelines, and all other Applicable Law.
IPEC Guidelines - the Joint IPEC-PQG Good Manufacturing Practices Guide For Pharmaceutical Excipients, current edition.
In the event that the results fail to meet the Specifications or acceptance criteria as defined in the SOPs, Durect will undertake any resulting investigations and other actions required as per the IPEC Guidelines and Durect’s internal SOPs.
Durect will be responsible for ensuring that its facilities, equipment and systems meet the IPEC Guidelines and Applicable Law in the Territory.
In the event that stability test results fail to meet the Specifications or acceptance criteria as defined in the SOPs, protocols, or release requirements, Durect will undertake any resulting investigations and other action required as per the IPEC Guidelines and Durect’s internal SOPs or protocols.
Durect shall manufacture the Finished [* * *] in compliance with the Specifications, the applicable IPEC Guidelines, and Applicable Laws in the Territory.
Durect shall perform the work detailed in all SOPs or protocols under the IPEC Guidelines, including laboratory testing, Quality Assurance review of data, and preparation of a final report.
Durect shall maintain the current and all future validations for all equipment and procedures which are used in the manufacture and testing of the Finished [* * *] in accordance with the IPEC Guidelines and Applicable Law in the Territory.