GMP Supplier Contract

Basic Principles of GMP
Contract Production,
Analysis and other
activities
Section 7
Contract Activities
Objectives
 To review general issues
 To understand the responsibilities of:

 Contract giver
 Contract acceptor
 To understand the contract
(Also referred to as “outsourced activities”)

Contract Activities
Principle
 Contract production, analysis and any other outsourced activity -
defined, agreed, and controlled.
 Should be in writing – to avoid misunderstandings
 Ensure work is done to GMP and as in marketing authorization
 Define duties and responsibilities of parties
 Address batch release (authorized person) and issue of certificate

of analysis
7.1 – 7.4
Contract Activities
Responsibilities of the Contract Giver (1)
 Must have a PQS in place, allowing for control and review of

outsourced activities. Assess legality, suitability, competence
 Ensure compliance with GMP and QRM principles applied
 Approve contracted activities
 Monitor and review its performance, including improvements

and effectiveness thereof.
7.5. – 7.9.
 Ensure understanding of inspections by regulators

Contract Activities
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 hazards with the product, work, tests that
might pose a risk to premises, equipment, personnel, other
materials or other products
 Ensure that materials and products supplied by the contract
acceptor are in compliance with specifications
 Products are released by the authorized person
7.6 – 7.7
Contract Activities
Responsibilities of
the Contract Acceptor (1)
 Must have a manufacturing authorization

 Must have:
 Adequate premises, equipment, knowledge,
experience
 Competent personnel
7.10
Contract Activities
Responsibilities of
the Contract Acceptor (2)
 No subcontracting to a third party without prior approval

(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)
7.11. - 7.12.
Contract Activities
The Contract (1)
 Written agreement defining each party’s responsibilities and
technical aspects – activities, products, operations,
communication process
 Prepared by competent persons with knowledge in
pharmaceutical technology, analysis and GMP
 Ensure compliance with marketing authorization
– Production and analysis
7.13., 7.15., 7.16.
– Batch release
– COA issued by the authorized person, compliance with marketing
authorization
– Flow of data and information for product quality review
Contract Activities
The Contract (2)

 Batch release, and issuing of COA described
 Knowledge management
 Technology transfer
 Supply chain
 Sub contracting
7.14., 7.17.
 Testing and release of material
 Production, quality control, in process control
Contract Activities
The Contract (3)

 How does it address rejected materials /products?
– starting materials
– intermediate and bulk products
– finished products
 What happens if the contract analysis shows that the
tested product must be rejected? 7.19.
Contract Activities
The Contract (4)
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?
 Where is the sample taken? 7.15, 7.17
 Describe procedure if a tested product must be rejected

Contract Activities
The Contract (4)
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
7.18.
Contract Activities
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?
Contract Activities
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

Contract Activities
Possible Issues – II
 Contract acceptor does not have all specified equipment
 Contract acceptor uses incorrect equipment
 Contract acceptor does not follow agreed procedures

Contract Activities
Possible Issues – III
 Contract acceptor uses an alternative material supplier
 Contract acceptor working with out-of-date specifications

GMP Supplier Contract

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Basic Principles of GMP

 To review general issues

 To understand the responsibilities of:

 To understand the contract

(Also referred to as “outsourced activities”)

 Should be in writing – to avoid misunderstandings

 Ensure work is done to GMP and as in marketing authorization

 Define duties and responsibilities of parties

 Address batch release (authorized person) and issue of certificate

 Must have a PQS in place, allowing for control and review of

 Ensure compliance with GMP and QRM principles applied

 Approve contracted activities

 Monitor and review its performance, including improvements

 Ensure understanding of inspections by regulators

 Must have a manufacturing authorization

 No subcontracting to a third party without prior approval

The Contract (2)

The Contract (3)

Who is responsible for:

In the case of contract analysis:

 Describe procedure if a tested product must be rejected

The contract giver should keep or have access to:

 In case of recalls, complaints and suspected defects:

 Identify the items that should be included in a contract

 Why should these items be included?

 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

 Contract acceptor does not have all specified equipment

 Contract acceptor uses incorrect equipment

 Contract acceptor does not follow agreed procedures

Possible Issues – III

 Contract acceptor uses an alternative material supplier

 Contract acceptor working with out-of-date specifications

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