BLUEWORLD PHARMACEUTICALS LIMITED
Km3 Deeper-Life Uzoiyi Road, Near Ipp Power Plant Off Aba-Ph Express-way, Umugo,
Ugwunagbor, L.G.A, Abia State, Nigeria
CHANGE CONTROL FORM
REF SOP No:
Change Control Request Number:
Change Control Title
Date Requested
CHANGE REQUESTER DETAILS
Name:
Designation:
Department:
DETAILS OF CHANGE CONTROL REQUEST
Change Type Process/Procedure Facility/Equipment Product
Material Utility Document
Nature of Change Temporary Permanent
Category of Change Minor Major Critical
Present Status:
Proposed Changes:
Reason for Change
(provide the supporting data)
IMPACT OF CHANGE
Names of impacted
Product(s) /Material(s)
Other departments affected by
the change
Processes impacted by the
change
Procedure impacted by the
change
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BLUEWORLD PHARMACEUTICALS LIMITED
Km3 Deeper-Life Uzoiyi Road, Near Ipp Power Plant Off Aba-Ph Express-way, Umugo,
Ugwunagbor, L.G.A, Abia State, Nigeria
CHANGE CONTROL FORM
REF SOP No:
System(s) impacted by the
change
Facility or equipment impacted
by change
Primary benefit of this change? Compliance Cost Safety Process Improvement
Assurance of supply others (Specify)
Has the availability of
resources for the change Yes / No / N/A
identified and agreed?
Indicate if all impacted
departments have been Yes / No / N/A
consulted about this change
proposal
Evaluation of change (to be filled by QA)
Is the data provided adequate for the assessment of the change Yes No
Is the change control complete and correct Yes No
Major: Any change in the product, production process, quality control,
equipment, facilities or responsible personnel that has a substantial potential of
having an adverse effect on the identity, strength, safety, quality, effectiveness, purity
Tick as applicable or potency of the product.
Minor: Any change in the product, production process, quality control,
equipment, facilities or responsible personnel that has a minimal potential of having
an adverse effect on the identity, strength, safety, quality, effectiveness, purity or
potency of the product.
Approval
Approved By:
Acceptable Rejected Sig Date
n
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BLUEWORLD PHARMACEUTICALS LIMITED
Km3 Deeper-Life Uzoiyi Road, Near Ipp Power Plant Off Aba-Ph Express-way, Umugo,
Ugwunagbor, L.G.A, Abia State, Nigeria
CHANGE CONTROL FORM
REF SOP No:
FOLLOW UP CLOSURE
All actions completed Yes No
Actions partially completed
(if any, please mention)
Reasons for partial completion
Does the implementation of the change(s) have any harmful impact on the product quality
Yes No NA
Closure comments:
Initiator Sig Date
n
Department Head Sig Date
n
Review and Closure by QA
Closed within timeframe Yes No
Change control form closed Yes No
QA Head Sign Date
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