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

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Completed by:  _______________________     Date:  ___________________________

Reviewed by:     ________________________   Date:  ____________________________