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An independence
Quality organization is a fundamental
requirement for regulatory compliance under cGMPs, QSRs,
GTPs and GLPs. We assist in the development and
review of our clients' quality organizations and
participate in preparation of suitable documents and
document control systems. The quality organization
must have the authority to fulfill the following
regulatory tasks and responsibilities:
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Approve or reject all
components, materials, containers / closures,
in-process materials, packaging materials and labeling.
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Approve or reject all bulk
substance (active pharmaceutical ingredient -
API) and final products.
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Establishment, operation and control
(approval/rejection) of documentation systems.
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Standard Operating
Procedures (SOPs) - Approximately 80 general
procedures are required by cGMPs and
approximately 50 are required by QSRs. In
addition, facility and manufacturing specific
procedures may increase the total number from a
few hundred to over a thousand for larger
operations. |
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Specifications for
components, materials, containers / closures,
in-process materials, packaging materials,
labeling and for API and final products.
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Master and batch production
and control records (cGMPs), device history
records (QSRs), HCT/P manufacturing and tracking
records (GTPs) or non-clinical study protocols
and reports (GLPs). |
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Validation/qualification
protocols, calibration and maintenance records,
as-built facility drawings and other documents.
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Documented training of employees and/or control
(approval/rejection) of training performed by
others. |
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Auditing (both internal and external)
to ensure regulatory compliance and to qualify
contractors and vendors.
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Quality control
laboratories for analytical and microbiological
testing. |
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Interaction with regulatory authorities,
agencies and
inspectors (although this is responsibility is
often performed by a separate regulatory
organization). |
The
QSIT
(Quality System Inspection Technique)
process used for FDA inspections by the Office
of Regulatory Affairs looks at the Quality
organization first and then at one or more other
cGMP / QSR functions.
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