| Good
Manufacturing Practice (GMP) |
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Reviews,
development and implementation of plans for new facilities and proposed
facility upgrades to ensure cGMP requirements are met, covering:
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Buildings
layout and internal construction/surface finishes |
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Materials
flow and personnel movement |
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Product
and materials storage |
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Equipment
|
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HVAC
Systems |
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Water
Systems |
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Sterilization
Systems |
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Preparation
of documentation, such as Standard Operating Procedures (SOPs), manufacturing
and packaging records, Quality Control specifications and test methods
and validation protocols
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Assessment
of GMP compliance to International Regulatory Standards, covering
the manufacture of :
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Nonsterile
formulations, such as tablets, capsules, creams, ointments,
external and internal liquids. |
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Sterile
formulations |
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Biotechnology
formulations |
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Active
Pharmaceutical Ingredients (API's) |
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Conducting
mock GMP audits, prior to regulatory authority audits, to assess the
level of GMP compliance
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Participation
in GMP audits by regulatory agencies and post audit follow up activities,
such as the preparation of a response to any issued audit report
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Development
of maintenance and equipment calibration programs
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|
GMP
training
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