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Chapter 7 Contract Production & Testing (The Contract Acceptor (no…
Chapter 7 Contract Production & Testing
The Contract Acceptor
carry out satisfactorily work
ordered by Contract Giver
has adequate premises, equipment, knowledge & experience, competent personnel
products @ materials
delivered to Contract Giver
suitable for their intended purpose
not pass to a third party
any of work entrusted to him
under the contract without Contract Giver’s prior evaluation & approval of arrangements
refrain from any activity
may adversely affect quality of product manufactured @ tested for contract giver
no batch of products
released for sale @ supply
certification by an authorized person
accordance with the requirements of Product Registration
arrangements made between CA & third party
manufacturing & analytical information
available in same way
as between original CG & CA
The Contract Giver
responsible for assessing
successfully carrying out work @ test required by Contract Acceptor
for ensuring by means of contract that principles of GMP described in guide be followed
provide all information necessary
to carry out contracted operations correctly
accordance with Product Registration documents
to Contract Acceptor
ensure CA fully aware of any problems
associated with product @ work
might pose a hazard to premises, equipment, personnel, other materials @ products
ensure material & finished product
delivered by the Contract Acceptor
comply with their specifications
Contract Testing
correctly defined, agreed & controlled
avoid misunderstandings
may result in a test of unsatisfactory quality
written contract agreement
between Contract Giver & Contract Acceptor
clearly establishes duties of each party
authorised person
clearly state the way
i.e. the chemist of the Contract Acceptor, exercises his @ her full responsibilities
Contract Production
correctly defined, agreed & controlled
avoid misunderstanding
may result in a product @ work of unsatisfactory quality
arrangement for contract manufacture
any proposed changes in technical @ other arrangements
accordance with registration requirements
for product concerned
Contract Giver
manufacturing & distribution records
reference samples
written contract agreement
between Contract Giver & Contract Acceptor
clearly establishes duties of each party
The Contract
specify the way
which head of QC Department
releasing batch for sale
ensures that each batch has been manufactured & checked
compliance with requirements of Product Registration
describe clearly
who is responsible
for purchasing materials, testing & releasing materials, undertaking production, QC
include IPQC, sampling & analysis
state whether @ not CA should take samples at premises of manufacturer
records
manufacturing, analytical & distribution records, reference samples
kept & available by Contract Giver
any records relevant to assessing quality of a product (complaints @ a suspected defect)
be accessible & specified in defect @ recall procedures of Contract Giver
permit
Contract Giver to visit facilities of Contract Acceptor
contract analysis
Contract Acceptor should understand
subject to inspection
by competent Authorities
be drawn up
contract
between CG & CA
specifies their respective responsibilities
relate to manufacture & control of product
technical aspects
by competent persons suitably knowledgeable
in manufacturing, analysis & GMP
arrangement for manufacturer & analysis
accordance with marketing authorization
agreed by both parties