Section 2-Quality Management ISPE India

ICH Q7A GMP
Guidance for APIs

Section 2
Quality
Management
Quality Management
ICH Q7A GMP GUIDANCE FOR APIs
• Principles
• Responsibilities of the Quality Unit
• Responsibility for Production Activities
• Internal Audits (Self Inspection)
• Product Quality Review
2
Quality Management
Most of the guidance in this

section is not new….
But in some cases, puts into writing

or clarifies current expectations
3
2.1 Principles
• Quality should be the

responsibility of ALL
• A quality system is
needed
• Independence of
Quality Unit(s)
• All activities recorded
at the time performed
4
2.1 Principles
Release of Materials
• Persons authorized to release intermediates
and APIs should be specified
5
Release Under Quarantine
No materials released or used before

satisfactory completion of evaluation by
Quality Unless appropriate systems in place to
allow for such use
API released to third parties only after
release by Quality
May be transferred under quarantine to
another unit under company control when
authorized by Quality with appropriate
controls/documentation (10.2) 6
Glossary Definition
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
Deviations
• Deviations documented and explained
• Critical deviations investigated
and documented
8
2 Responsibilities
2.2 Responsibilities of the Quality Unit

• Involved in all quality-related activities
• Review and approve all quality related documents
• Non-delegatable activities
2.3 Responsibility for Production Activities
• Intentionally did not refer to “Production Unit”
• Depending on company some of these functions are
performed by production, engineering, technical
maintenance, etc
• Did not want to impose organizational structure
9
2 Responsibilities
Responsibilities that
should NOT be
delegated
10
Clarification of terms
Release: final authority
Review and approval: authority but this may

be shared authority. More than one group or
person may be required to review and approve.
Making sure: that other group performs and

quality oversees or checks
11
2.2 Quality Responsibilities
Responsibilities that should NOT be delegated

• Releasing or rejecting all APIs
• Releasing or rejecting intermediates for use
outside the control of the manufacturing company
• Reviewing completed batch production and lab
control records of critical process steps before
release of the API
• Performing product quality reviews
12

Approving
• All specifications and master production instructions
• All procedures impacting the quality of APIs or
intermediates
• Contract manufacturers
• Changes that potentially impact the quality of APIs
or intermediates
• Validation protocols and reports
13

Making sure that
• critical deviations are investigated and resolved
• internal audits are performed
• effective systems are used for maintaining and calibrating critical
equipment
• materials are appropriately tested and the results reported
• there is stability data to support retest or expiry dates and storage
conditions
14
2.3 Quality and Production
Responsibilities
Some similarities, but intentional differences
QU P
• Approving all • Preparing, reviewing,
specifications and master approving instructions for
production instructions the production of APIs
and intermediates
15
Responsibilities
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
16
Responsibilities
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
17
2.4 Internal Audits
• To verify compliance with the

principles of GMP for APIs
• Performed regularly in
accordance with an approved
schedule
18
2.4 Internal Audits
• Audit findings and corrective action

– documented
– brought to attention of responsible
management
• Corrective actions completed in

timely and effective manner
19
2.5 Product Quality Review
(Annual Product Review)
• Regular quality review

to verify the consistency
of the process
• Normally conducted
and documented
annually
20
Review should include:

• critical in-process controls and critical API test results
• batches failing specifications
• critical deviations or non-conformances
• changes to process or analytical methods
• results of stability monitoring program
• quality related returns, complaints, recalls
• adequacy of corrective actions
21
(Annual Product Review)
Results should be evaluated

and an assessment made of
need for corrective action or
revalidation
22
ICH Q7A GMP
Guidance for APIs
Section 2
Quality
Management

Section 2-Quality Management ISPE India

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Verfügbare Formate

Section 2-Quality Management ISPE India

Hochgeladen von

Copyright:

Verfügbare Formate

ICH Q7A GMP

Guidance for APIs

Most of the guidance in this

But in some cases, puts into writing

• Quality should be the

No materials released or used before

2.2 Responsibilities of the Quality Unit

Release: final authority

Review and approval: authority but this may

Making sure: that other group performs and

Responsibilities that should NOT be delegated

Responsibilities that should NOT be delegated

Responsibilities that should NOT be delegated

Some similarities, but intentional differences

Some similarities, but intentional differences

Some similarities, but intentional differences

• To verify compliance with the

• Audit findings and corrective action

• Corrective actions completed in

• Regular quality review

Review should include:

Results should be evaluated

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