PRINCIPLE
Contract manufacture
and analysis must be correctly defined, agreed and controlled in order to avoid
misunderstandings which could result in a product or work of unsatisfactory
quality. There must be a written contract between the Contract Giver and the
Contract Acceptor which clearly establishes the duties of each party. The
contract must clearly state the way in which the head of Quality Management
(Quality Assurance) releasing each batch of product for sale exercises his full
responsibility.
Note: This Chapter
deals with the responsibilities of manufacturers towards the Drug Regulatory
Authority (DRA) with respect to the granting of marketing and manufacturing
authorizations. It is not intended in any way to affect the respective
liability of contract acceptors and contract givers to consumers.
GENERAL
There should be a
written contract covering the manufacture and/or analysis arranged under
contract and any technical arrangements made in connection with it.
All arrangements for
contract manufacture and analysis including any proposed changes in technical
or other arrangements should be in accordance with the marketing authorization
for the product concerned.
The contract should
permit the contract giver to audit the facilities of the contract acceptor.
In the case of
contract analysis, the final approval for release must be given by the head of
Quality Management (Quality Assurance) of the contract giver.
THE CONTRACT GIVER
The Contract Giver is
responsible for assessing the competence of the Contract Acceptor to carry out
successfully the work or tests required and for ensuring by means of the
contract that the principles and Good Manufacturing Practices Guidelines as
interpreted in these Guidelines are followed.
The Contract Giver
should provide the Contract Acceptor with all the information necessary to
carry out the contracted operations correctly in accordance with the marketing
authorization and any other legal requirements. The Contract Giver should
ensure that the Contract Acceptor is fully aware of any problems associated
with the product or the work or tests which might pose a hazard to his
premises, equipment, personnel, other materials or other products.
The Contract Giver
should ensure that all processed products and materials delivered to him by the
Contract Acceptor comply with their specifications or that the products have
been released by the head of Quality Management (Quality Assurance).
THE CONTRACT ACCEPTOR
The Contract Acceptor
must have adequate premises and equipment, knowledge and experience, and
competent personnel to carry out satisfactorily the work ordered by the
Contract Giver. Contract manufacture may be undertaken only by a manufacturer
holding GMP certificate issued by the Drug Regulatory Authority (DRA).
The Contract Acceptor
should ensure that all products or materials delivered to him are suitable for
their intended purpose.
The Contract Acceptor
should not pass to a third party any of the work or tests entrusted to him
under the contract without the Contract Giver's prior evaluation and approval
of the arrangements. Arrangements made between the Contract Acceptor and any
third party should ensure that the manufacturing and analytical information is
made available in the same way as between the original Contract Giver and
Contract Acceptor.
The Contract Acceptor
should refrain from any activity which may adversely affect the quality of the
product manufactured and/or analyzed for the Contract Giver.
THE CONTRACT
A contract should be
drawn up between the Contract Giver and the Contract Acceptor which specifies
their respective responsibilities relating to the manufacture and control of
the product. Technical aspects of the contract should be drawn up by competent
persons suitably knowledgeable in pharmaceutical technology, analysis and Good
Manufacturing Practices. All arrangements for manufacture and analysis must be
in accordance with the marketing authorization and agreed by both parties.
The contract should
specify the way in which the head of Quality Management (Quality Assurance)
releasing the batch for sale ensures that each batch has been manufactured and
checked for compliance with the requirements of Marketing Authorization.
The contract should
describe clearly who is responsible for purchasing materials, testing and
releasing materials, undertaking production and quality controls, including
in-process controls, and who has responsibility for sampling and analysis. In
the case of contract analysis, the contract should state whether or not the
Contract Acceptor should take samples at the premises of the manufacturer.
Manufacturing,
analytical and distribution records, and reference samples should be kept by,
or be available to, the Contract Giver. Any records relevant to assessing the
quality of a product in the event of complaints or a suspected defect must be
accessible and specified in the defect / recall procedures of the Contract
Giver.
The contract should
permit the Contract Giver to visit the facilities of the Contract Acceptor.
In case of contract
analysis, the Contract Acceptor should understand that he is subject to
inspection by the Drug Regulatory Authority (DRA).
The contract should
describe the handling of starting materials, packaging materials, intermediate
and bulk products and finished products if they are rejected. It should also
describe the procedure to be followed if the contract analysis shows that the
tested product must be rejected.
