Pharmaceutical labeling requirements
Purpose
To describe the procedure for status labeling system
during various stages of operation.
Procedure
Status labeling is defined as identification of the
materials, equipment’s, containers, instruments for the intended purpose and
present status. This is required to prevent the mixing, cross contamination,
proper handling, storage and smooth working to maintain the cGMP requirements.
All labels shall be designed with respect to
Description, Color name & colour band given in reference label summary.
Status label shall confirm to status of
Material/Product/Equipment/Area.
Various label description and their application with
responsibility shall be.
User department shall indent for the label &
maintain inventory and handling of label.
Label receipt and issuance shall be maintained
Labels shall be affixed on defined place after filling
the required information in respective columns.
Concern Department Head shall be responsible for
handling of relevant labels. QA shall ensure the adherence of issuance and
consumption record.
Electronic labeling storage in case of unavailability
of printed label.