Professional Documents
Culture Documents
• Principles
• Responsibilities of the Quality Unit
• Responsibility for Production Activities
• Internal Audits (Self Inspection)
• Product Quality Review
2
Quality Management
ICH Q7A GMP GUIDANCE FOR APIs
3
2.1 Principles
ICH Q7A GMP GUIDANCE FOR APIs
4
2.1 Principles
ICH Q7A GMP GUIDANCE FOR APIs
Release of Materials
• Persons authorized to release intermediates
and APIs should be specified
5
Release Under Quarantine
ICH Q7A GMP GUIDANCE FOR APIs
Critical:
Describes a process step, process
condition, test requirement, or other
relevant parameter or item that must be
controlled within predetermined
criteria to ensure that the API meets
its specification.
7
2.1 Principles
ICH Q7A GMP GUIDANCE FOR APIs
Deviations
• Deviations documented and explained
• Critical deviations investigated
and documented
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2 Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
Responsibilities that
should NOT be
delegated
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Clarification of terms
ICH Q7A GMP GUIDANCE FOR APIs
12
2.2 Quality Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
13
2.2 Quality Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
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2.3 Quality and Production
Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
QU P
• Approving all • Preparing, reviewing,
specifications and master approving instructions for
production instructions the production of APIs
and intermediates
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2.3 Quality and Production
Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
QU P
• Reviewing completed • Reviewing all
mfg records for critical production records and
process steps before ensuring these are
release of API for completed and signed
distribution
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2.3 Quality and Production
Responsibilities
ICH Q7A GMP GUIDANCE FOR APIs
QU P
• Making sure that • Making sure that the
effective systems are necessary calibrations
used for maintaining and are performed and
calibrating critical records are kept
equipment
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2.4 Internal Audits
ICH Q7A GMP GUIDANCE FOR APIs
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2.4 Internal Audits
ICH Q7A GMP GUIDANCE FOR APIs
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2.5 Product Quality Review
(Annual Product Review)
ICH Q7A GMP GUIDANCE FOR APIs
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2.5 Product Quality Review
ICH Q7A GMP GUIDANCE FOR APIs
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ICH Q7A GMP
Guidance for APIs
Section 2
Quality
Management