Personnel
Part One, 10
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Personnel
Objectives
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Principle
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Personnel
General - I
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Personnel
General - II
Organization Chart
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Personnel
General - III
Motivated to
support the establishment
maintain high-quality standards
Part One 10.4
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Personnel
General - IV
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Personnel
Key Personnel - I
Key personnel (which normally should be
full-time) positions include:
Head of Production
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Personnel
Key Personnel - II
Key personnel should posses the qualifications of:
Practical experience.
under professional guidance
Part One 10.7
able to take difficult decisions in a professional and scientific
way,
resolve the problems encountered in manufacturing and QC.
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Personnel
Shared Responsibilities I
Heads of Production and Quality Control may share
some responsibilities depending on national
regulations:
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Shared Responsibilities II
retention of records
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Head of Production Responsibilities - I
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Head of Production Responsibilities - II
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Head of Quality Control Responsibilities - I
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Head of Quality Control Responsibilities II
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Personnel
Useful reference documents for
inspectors:
Organization Chart
Job descriptions
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Personnel
Training - I
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Training - II
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Visitors or Untrained Personnel
Preferable not to take them in. If this is unavoidable,
for example GMP inspectors:
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Personnel
Group Session
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Possible Issues I
Inadequate qualifications
Inadequate experience
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Personnel
Possible Issues II
Staff movement
Illness
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