Transcript Basic Principles of GMP Contract Production and Analysis Section 7 Module 6 | Slide 1 of 14 January 2006

Basic Principles of GMP
Contract Production
and Analysis
Section 7
Module 6
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Slide 1 of 14
January 2006
Contract Production and Analysis
Objectives
 To review general issues
 To understand the responsibilities of:
 Contract giver
 Contract acceptor
 To understand the contract
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Slide 2 of 14
January 2006
Contract Production and Analysis
Principle
Contract production and analysis must be correctly defined,
agreed, and controlled:
 To avoid misunderstandings that could result in unsatisfactory
products, work or analysis
 A written contract should clearly describe:
 Each party's duties and responsibilities including audits
 Clearly state how the authorized person, when exercising his
or her full responsibility, releases each batch or issues
certificate of analysis
7.1 – 7.4
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Slide 3 of 14
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Contract Production and Analysis
Responsibilities of the Contract Giver (1)
 Must assess competence of contract acceptor to do the work or
analysis
 Must assess contract acceptor for compliance with GMP
 Approve contracted activities
7.5
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Slide 4 of 14
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Contract Production and Analysis
Responsibilities of the Contract Giver (2)
 Provide all the necessary information to the contract acceptor in
order to:
 have the operations carried out correctly in accordance with the
manufacturing authorization and other legal requirements
 be fully aware of any problems with the product, work, tests that
might pose a hazard to premises, equipment, personnel, other
materials or other products
 Ensure that materials and products supplied by the contract
acceptor are in compliance with specifications, or
 Products are released by the authorized person
7.6 – 7.7
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Slide 5 of 14
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Contract Production and Analysis
Responsibilities of
the Contract Acceptor (1)
 Must have a manufacturing authorization
 Competence:
 Have the necessary facilities, premises and equipment to
undertake the work
 Staff should have the necessary qualifications, knowledge,
training and experience to be able to do the work
7.8
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Slide 6 of 14
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Contract Production and Analysis
Responsibilities of
the Contract Acceptor (2)
 No subcontracting without prior approval to a third party
(The contract giver must be able to undertake audits needed to
reassure that the third party is competent and approve
subcontracting)
 All the required information should be given to the third party
 No conflicting activities or practices that could adversely affect
the product(s)
7.9 - 7.10
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Slide 7 of 14
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Contract Production and Analysis
The Contract (1)
 Written: Defining each party’s responsibilities
 Technical aspects drawn up by competent persons with
knowledge in pharmaceutical technology, analysis and GMP
 Batch release/COA issued by the authorized person, compliance
with marketing authorization
 Production and analysis arrangements as in marketing
authorization – agreed to by both parties
 Describe handling of rejected materials
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Slide 8 of 14
January 2006
7.11 - 7.14, 7.17
Contract Production and Analysis
The Contract (2)
Who is responsible for:
 Material purchasing, testing and releasing
 Production and quality control including in-process quality control
(IPQC)
 Sampling and analysis
In the case of contract analysis:
 Who takes the sample?
7.15, 7.17
 Where is the sample taken?
 Describe procedure if a tested product must be rejected
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Slide 9 of 14
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Contract Production and Analysis
The Contract (3)
The contract giver should keep or have access to:
 Reference standards and retention samples
 Records of:
 manufacturing
 analysis
 distribution
 In case of recalls, complaints and suspected defects:
 all relevant records
 described in SOP
7.16
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Slide 10 of 14
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Contract Production and Analysis
Group Session
 Identify the items that should be included in a contract
 Why should these items be included?
 What should you do if you find a contract that does not include
these items?
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Slide 11 of 14
January 2006
Contract Production and Analysis
Possible Issues – I
 Owners insist on using unsuitable facilities
 Owners insist on using relatives’ facilities
 No time to validate new facilities
 Contract acceptor takes on inappropriate new product
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Contract Production and Analysis
Possible Issues – II
 Contract acceptor does not have all specified equipment
 Contract acceptor uses incorrect equipment
 Contract acceptor does not follow agreed procedures
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Slide 13 of 14
January 2006
Contract Production and Analysis
Possible Issues – III
 Contract acceptor uses an alternative material supplier
 Contract acceptor working with out-of-date specifications
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Slide 14 of 14
January 2006