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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