Master Batch Record Sample
Appendix 6: Sample master formula for a hypothetical biological product Appendix 7: Example one of a Master Formula Appendix 8: Example two of a ... 9) Issuing of MF copy as a blank batch record While Master Formulae are almost invariably stored on the computer, the official signed form is a paper copy.
Master Batch Record: [18 F]FPS Cyclotron Reagents / Materials: [18 F] Fluoride Item Reagent / Material Specifications Manufacturer Lot # Expiration Date 1 18 O water ... F] fluoride vial` Clean Alltech or equiv. N/A N/A 1 4 V-Vial, septum and cap `Reaction vial` Clean, depyrogenated Alltech or equiv. N/A N/A 1 5 Sample vial ...
COMPANY C. MASTER BATCH MANUFACTURING RECORD number: MBMR XXXX, version X Department XXXXXXXXXXXXX Page: 2 of 10 Process Step Revival of Working Cell Bank, Inoculation ... off Agitator controls, Stop Air flow Temp. controller and recorder switched off Agitator controls switched off Air flow stopped Sample drawn ...
Document No. SOP 3101, B01 Revision No. 01 Effective Date 02 June 2008 Supersedes Date 30 June 2006 Page 4 of 77 Document Title: P URIFIED H UMAN P ANCREATIC I SLETS , M ASTER P RODUCTION B ATCH R ECORD Lot Number: Fill Infusion Bags Sample Final Islet Product Transfer Product to Clinical Team ...
Each copy of the Master Batch Record for such Batch of Drug Product shall be assigned a unique batch number. Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the copy of the Master Batch Record for that Batch.
... Boston/Waltham, MA Registration/Continental Breakfast Fundamentals: What is Needed and Fundamental requirements of a Master Production Batch Record ... 550 Winter St. Waltham, MA 02451 781-890-6767 Doubletree Guest FDA COMPLIANCE DIGEST To view our November 2009 Sample ...
Product Data Sheet Batch Production Record (BPR) v4.3 March 2010—Page 1 Batched Printing of Records (BPR) Eliminate wasted time and money during the ... Used with Document Control and Archiving (DCA) , BPR ensures that only the current effective master production record is used.
The amended document should be replaced at the earliest opportunity by a newly prepared master formula. Batch documentation 28A batch manufacturing record should be completed ... that the batch has been sampled in accordance with a sampling plan that ensures a representative sample of the batch is taken.
... Drug Master File (DMF) to the IMB • CEP application to EDQM • Copies of DMFs may be required in advance • Copy of Master Batch Record (translated) Slide 15 ... Sample deficiencies from inspections • This section is delivered as follows: • Deficiencies identified at the Contract Giver site (within the ...
Elimination of the cost to manage and control the paper master batch records and photocopying ... É Decisions on how to handle the current documentation that is not part of the master batch record (i.e ... until an end-point specification has been achieved. É The requirements for tracking sample ...
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