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GMP for Clinical Trial Material

IPRNetJapan

Sumio Watanabe

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GMP for Clinical Trial Material,CTM

GMP: controlling direction-pursuance-documentation system for resource, personnel, facility and equipment, in manufacturing site of drug substance and product

GMP for CTM＝GMP for commercial productSponsor prepare all of information for manufacturing of CTM and manufacturing site adjust the system to sponsor’s information

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GMP for CTM

In GCP guidance Shourei number28 article17, sponsor for clinical study have to supply the clinical site with qualified CTM manufactured under the “GMP for CTM”

.

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Sponsor for Clinical Study

Prepare standard for CTM

In manufacturing site, standards for control of Manufacturing and control of quality reflect in the standard for CTM presented by the sponsor

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Standard for CTMFor each clinical material and each manufacturing

site、General information；Name, Chemical

Structure, ･･･Quality Control；Specifications and their test

methods･･･Manufacturing Control；Manufacturing method

with critical process･･･ Summary of clinical study etc.

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Sponsor

For each manufacturing site、three responsible person are assignedSecurity person

Responsible person for manufacturingResponsible person for quality control

all of events in both person’s purview are reported for security person

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Security personsupervise both persons with the responsibility

for manufacturing and quality control in stand point compliance GMPsupervise contract manufacturerdecide shipping CTMcarry out validation(if necessary), self-

inspection and educational training for personnel

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Responsible person for manufacturingmanufacture CTM in compliance with Master

Production Record(MPR) and document Batch Production Record(BPR)

verify and document appropriately performed labeling and packaging

appropriately conserved and document in/out of ingredients and CTM

verify and document appropriate cleaning processing booth and equipment

supervise and document health of personnel document periodical inspection and calibration of

equipment

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Responsible person for quality control document sampling method and amount for

ingredients and CTM test and document sampling materials conserve more than double amount of CTM to full

test of specification document periodical inspection and calibration of

equipment and instrument

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Sponsor for CTM appropriately performed validation if it is

necessity for manufacturing and quality control of CTM

investigate and document ground of claim and solution for the requires, if it is necessity

investigate and document reason of recall and solution for the requires, if it is necessity

perform self inspection

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Contract

purview of contract technology of contract conformation for appropriately performed

manufacturing or quality control direction and supervise for contractee In coming site and test of products

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Contractee

In compliance with GMP for CTM

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Standards for manufacturing facility and equipment

same to requirements of GMP for commercial products

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Summary of manufacturing and quality control for CTM

Sponsor；prepare all of information for manufacturing and quality control

Manufacturing site;arrange standards for Control of Manufacturing and for control of quality to reflect the Sponsor ‘s information