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Guideline
and Standards |
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Description |
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21 CFR Part 11
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This Regulation provides criteria for
acceptance by Federal Drug Administration
(FDA), under certain circumstances, of
electronic records, electronic signatures,
and handwritten signatures executed to
electronic records as equivalent to paper
records and handwritten signatures executed
on paper. |
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Part 11 Guidance
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This document provides guidance to persons
who, in fulfillment of a requirement in a
statute or another part of FDA's regulations
to maintain records or submit information to
FDA, have chosen to maintain the records or
submit designated information electronically
and, as a result, have become subject to
part 11. |
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Pharmaceutical
CGMP's for the 21st Century
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In August 2002, the Food and Drug
Administration (FDA or the Agency) announced
a significant new initiative, Pharmaceutical
Current Good Manufacturing Practices (CGMPs)
for the 21st Century, to enhance and
modernize the regulation of pharmaceutical
manufacturing and product quality — to bring
a 21st century focus to this critical FDA
responsibility. The initiative, which this
final report describes in detail, was
intended to modernize FDA’s regulation of
pharmaceutical quality for veterinary and
human drugs and select human biological
products such as vaccines.
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General
Principles of Software Validation
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This guidance outlines general validation
principles that the FDA considers to be
applicable to the validation of medical
device software or the validation of
software used to design, develop, or
manufacture medical devices.
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21 CFR
Part 210 and 211 |
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The minimum current good manufacturing
practice for methods to be used in, and the
facilities or controls to be used for, the
manufacture, processing, packing, or holding
of a drug to assure that such drug meets the
requirements of the act as to safety, and
has the identity and strength and meets the
quality and purity characteristics that it
purports or is represented to possess. |
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21 CFR
Part 820 |
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The
FDA
issued a final ruling prescribing current
good manufacturing practices (cGMP) for the
method used in, and the facilities and
controls used for the manufacture, packing,
storage and installation of medical devices.
This regulation became effective in and is
codified under Title 21 Code of Federal
Regulations (CFR) 820. |
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Guidance
to Inspection of Computerized Systems in Drug Processing |
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The purpose of this guide is to provide the
field investigator with a framework upon
which to build an inspection of drug
establishments which utilize computer
systems.
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Computerized
Systems Used in Clinical Trials |
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This guidance addresses how these elements
of data quality might be satisfied where
computerized systems are being used to
create, modify, maintain, archive, retrieve,
or transmit clinical data. |
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Good Automated
Laboratory Practices (GALPs) |
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Environmental Protection Agency's (EPA)
GALP's have been developed long before 21CFR
Part 11 has been released. However, it
includes many elements related to electronic
records and can be used as an additional
guidance on how to implement electronic
records in laboratories.
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Guideline
on General Principles of Process Validation |
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This guideline outlines general principles
that FDA considers to be acceptable elements
of process validation for the preparation of
human and animal drug products and medical
devices. |
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Guide
to Inspections Validation Of Cleaning Processes |
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This guide is designed to establish
inspection consistency and uniformity by
discussing practices that have been found
acceptable (or unacceptable).
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Good Laboratory Practices (21
CFR 58) |
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Prescribes good Laboratory practices for
conducting non-clinical laboratory studies
that support or are intended to support
applications for research or marketing
permits for products regulated by the FDA.
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Good Clinical Practices |
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An international ethical and scientific
quality standard for designing, conducting,
recording and reporting trails that involve
the participation of human subjects. |
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Quality System
Regulation |
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The Food and Drug Administration (FDA) is
revising the current good manufacturing
practice (CGMP) requirements for medical
devices and incorporating them into a
quality system regulation. The quality
system regulation includes requirements
related to the methods used in, and the
facilities and controls used for, designing,
manufacturing, packaging, labeling, storing,
installing, and servicing of medical devices
intended for human use. |
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Sarbanes Oxley Act of 2002 |
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The Sarbanes-Oxley Act of 2002, sponsored by
US Senator Paul Sarbanes and US
Representative Michael Oxley, represents the
biggest change to federal securities laws in
a long time. It came as a result of the
large corporate financial scandals involving
Enron, WorldCom, Global Crossing and Arthur
Andersen. Effective in 2004, all
publicly-traded companies are required to
submit an annual report of the effectiveness
of their internal accounting controls to the
SEC. |
