MBR-cross functional team (CFT) Leader / Relevant Stakeholder / Designee shall be responsible for.
Serving as a final approver for MBRs, Protocols, and Reports.
Ensuring all paper-based or electronic documents related to the manufacture of intermediates, APIs, Finished Products or devices prepared, executed, reviewed, approved, signed, and dated by appropriately trained, responsible persons and distributed according to written procedures.
Production, Packaging, and Quality, also between other sites and third party manufacturers during technology transfer activities) and to define applicable security controls both within on-site departments and during off-site transfers.
Establishing Chain-of-Custody procedures to control the transfer of MBR’s and BPRs between document users, (e.g.
Establishing a system to prevent inadvertent use of superseded documents to ensure only current versions are accessible to authorized users.
The archival of these documents will follow written procedures as per the SOP of Documents & Records.
Maintaining a GMP compliant document control system for the review, approval, issuance, and maintenance of pMBRs, eMBRs, pBPRs,eBPRs, and hBPRs throughout the product lifecycle.
Recording the unique Master Batch Record (MBR) and BPR identifying number into a controlled logbook or electronic tracking system when the record created/issued.
Establishing procedures to enable document control personnel to assign a unique identification number to each Master Batch Record (MBR) and to assign sequentially ordered, unique identifying numbers to each BPR.
Defining the numbering and formatting conventions in procedures for Master Batch Record (MBR)s.
Authorizing and overseeing creation of Master Batch Record (MBR) procedures.
Quality Assurance (QA) Head/Designee shall be responsible for.
Archiving of all GMP documentation and records within a department or unit.
Maintaining responsibility while delegating authority for.
Supporting a Cross-Functional Team (CFT) approach by assigning a team leader and qualified personnel from across various functions and departments appropriate to the tasks identified throughout the Master Batch Record preparation process.
Assuring the provision of adequate resources.
Operate efficiently with goals oriented toward maintaining sustainable compliance.
Providing leadership to ensure that ongoing Master Batch Record (MBR)….
Head Production shall be responsible for.
Good Documentation Practices (GDP) SOP.
This SOP applies to Master Batch Records (MBR) in both paper-based (pMBR) and electronic (eMBR) formats and extends to paper-based Batch Production Records (pBPR), electronic Batch Production Records (eBPR) or hybrid Batch Production Records (hBPR) where a validated computer system utilizing an eMBR file generates then prints an exact match on paper to be used as an executable hBPR.
This SOP applies to Master Batch Records (MBR) for biological products, drug substances, drug products, bulk products, intermediates, and medical devices manufacturing.
A controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Manufacturing Practices (cGMPs).
The purpose of this procedure is to establish uniform requirements and guidelines utilizing a risk-based systems approach for.
SOP for Master Batch Record (MBR) 1.0 PURPOSE: Standard Operating Procedure (SOP) for preparation, review, approval, issuance, maintenance, and archival of controlled Master Batch Record (MBR) throughout the product lifecycle to meet and maintain sustainable compliance to current Good Manufacturing Practices (cGMPs).
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