Trial Checklist

Trial Checklist




  Trial Activities
Needed
(Y/N)
Person
Responsible
Date
Required
Comments
Iniital 
Reason for Trial and its objective have been identified




Is this the most practical, cost effective way of achieving the trial outcome?





EARLY PREPARATION
Trial co-ordinator appointed




Trial acceptance criteria established




Timeframe for completion established




Does change control system need to be followed as a result of the trial?




Does this trial have any impact on the product registration?




Any GMP issues identified




Any EHS issues identified




Does each department, including the laboratories, have the resources to
support the trial - List each affected department separately?




Number and size of product batch to be used decided




Product saleable or non-saleable




Has time been planed into the production schedule for trial




Are all trial components available? List all components required separately




Are test methods available for all required testing?




Trial protocol and documentation written and approved




Are Manufacturing Instruction sheets available?




Any amendment to Manufacturing Instruction sheets required?





Trial BPN raised (if appropriate)





Deviation Report (DR) raised to hold the batch if saleable product.





Laboratory has been made aware of dates and number of samples for testing.





Pre-trial training required?





COMPLETION
Nominated person assigned on process area




Completed trial documents have been reviewed by production




Completed trial documents have been reviewed by production




Trial conclusion written and approved




Trial outcome has been communicated to all affected parties




Any affected documentation has been updated




All non-saleable trial material has been destroyed






Comments:  __________________________________________________________________________________________________________           
 ___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
___________________________________________________________________________________________________________________
Completed by:  _______________________     Date:  ___________________________

Reviewed by:     ________________________   Date:  ____________________________

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