Controlled Documentation Clause Samples
The Controlled Documentation clause establishes procedures for managing and maintaining official documents within an organization or between contracting parties. It typically outlines how documents are created, reviewed, approved, distributed, and updated, ensuring that only the most current and authorized versions are in use. This clause helps prevent confusion or errors caused by outdated or unauthorized documents, thereby ensuring consistency, compliance, and quality control in operations or contractual relationships.
Controlled Documentation. All manufacturing, testing, and storage operations performed by C*P for the PRODUCTS will have CLIENT Quality review and written approval.
Controlled Documentation. All manufacturing and testing will be performed in accordance with the specifications listed in the MSA. These specifications will be approved by PATHEON and CEPHALON.
Controlled Documentation. 10.1.1 All manufacturing, testing, and storage operations performed by C*P for the PRODUCTS will have POZEN Quality review and written approval within five business days of notification.
10.1.2 Any significant changes as described in C*P Change Control Procedure or to this agreement will be mutually agreed upon in writing prior to implementation. All required regulatory approvals will be obtained prior to implementation.
Controlled Documentation. 4.5.1.1 Quality system documents comprises the following type documents:
Controlled Documentation. 10.1.1 All manufacturing, testing, and storage operations performed by C*P for the PRODUCTS will have ORPHAN Quality review and written approval within five business days of notification. ORPHAN’S Quality review and approval signifies the conformance of C*P documents to ORPHAN’S CMC regulatory submissions.
Controlled Documentation. 10.1.1 All manufacturing, testing, and storage operations performed by C*P for the PRODUCTS will have ORPHAN Quality review and written approval within five business days of notification. ORPHAN’S Quality review and approval signifies the conformance of C*P documents to ORPHAN’S CMC regulatory submissions.
10.1.2 Any significant changes will be mutually agreed upon in writing prior to implementation. All required regulatory approvals will be obtained prior to implementation.
10.1.3 ORPHAN shall provide to C*P a list of all documents referenced in the CMC submissions which are subject to Change Control. These documents will be required to be approved by both ORPHAN and C*P, and both parties agree to subject these documents for approval per Change Control. ORPHAN shall be responsible for meeting regulatory submission requirements based on the status of these documents. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Controlled Documentation. 8.2.1 All manufacturing, testing and storage operations performed for the PRODUCTS will have IDEC Quality review and written approval. Quality Agreement 9 June 1999 12
8.2.2 The Quality Departments of IDEC and SCHERING will determine which of these controlled documents also require a SCHERING Quality review and written approval.