-Definition:
-Hold time is defined as time period
for which materials (intermediates and bulk dosage form awaiting final packaging)
may be held under specified conditions and will remain within the defined
specifications.
-Following the objective of holding
time study:
Product
remains stable before processing to the next stage
meets
the acceptance criteria for the finished product
meets its stability specifications
-Hold-time studies establish the time
limits for holding the materials at different stages of production to
ensure that the quality of the product does not produce results outside the
acceptance criteria during the hold time.
-Hold times should normally be
determined prior to marketing of a product.
-Manufacturers
should gather sufficient data to demonstrate that a product for that
holding time study shall be performed.
-Written protocol of the holding time study
shall be prepared before the execution of the protocol.
-Protocol shall be include following
content, Purpose, scope, responsibility,
frequency for sampling, type of packing container and storage condition,
test parameters, acceptance criteria.
-Microbiological analysis shall be
performed if required.
-Hold
times should be determined prior to marketing of a product and following any
significant changes in processes, equipment, packaging materials, etc.
-Hold-time data under specified conditions
should demonstrate comparable stability to the dosage form in the marketed
package.
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