1.1 Basic Concepts of GLP/GMP
1.1.1 GLP/GMP
TOC-V Administrator’s Manual
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1.1 Basic Concepts of GLP/GMP
1.1.1 GLP/GMP
GLP (Good Laboratory Practice) is a quality system that ensures the reliability of
analysis and inspection data, and GMP (Good Manufacturing Practice) defines the
standards for ensuring quality control of manufactured pharmaceutical products as well
as proper manufacturing standards. GLP and GMP are defined in United States Title 21
Code of Federal Regulations.
Inspection reliability is ensured using a method that guarantees the transparency of the
inspection process. All documentation associated with the job of inspection is
standardized, and the inspection process is recorded and archived.
A department or section, separate from the actual inspection system, is established to
perform scheduled periodic checks on the equipment and system accuracy to ensure
reliability.
The key point of this method is to manage the entire process (validation, work flow,
data) used to obtain the results, and to leave a record of that process so that it can be
used as an audit trail for the purpose of verification.
TIP: GLP/GMP are regulations for performing proper analysis and inspection. It
incorporates effective ideas for conducting the work properly and is a useful tool even
in analytical laboratories where GLP/GMP is not required.
1.1.2 FDA 21 CFR Part 11
The FDA (Food and Drug Administration of the United States) Title 21 of the Code of
Federal Regulations Part 11 (abbreviated as FDA 21 CFR Part 11) stipulates the
compliance requirements by which “electronic records and electronic signatures” are
considered equivalent to “written records and hand written signatures”.
This regulation is used to speed up the FDA approval for new pharmaceuticals
marketed in the United States. Through this regulation, electronic signatures can be
legally used with documents in electronic format, such as global and commercial
transactions and documents output from a computer.
This regulation recognizes electronic data that is generated from computerized
analytical instruments that comply with the FDA 21 CFR Part 11 even if they are
located outside the United States. This regulation is not limited to the fields of
pharmaceuticals and food manufacturing. This regulation provides a means of
substituting electronic data for paper-based data and details proper record retention
procedures.
The FDA 21 CFR Part 11 regulation deals mainly with data integrity (security), data
completeness (data and metadata) and audit trail capability. The TOC-Control V
software supports the FDA 21 CFR Part 11 data regulations.
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