Hold Time Study, Purpose:
Hold Time Study, To establish a procedure for determination of in-process holding time limits.
Hold Time Study, Scope:
This procedure is applicable for all products to be manufactured at both General block and Sterile block of XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]RH – Relative Humidity
[][]NMT – Not more than
[][]QA – Quality Assurance
[][]SOP – Standard Operating Procedure
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To ensure proper handling & storage of hold time sample following this SOP.
Executive, Quality Control
[][]To be responsible to provide analytical support
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
[][]Hold time study for dispensed materials (Active materials), blended granules, bulk tablet, coated tablets, bulk capsules, blister strips, filled bottles to be done.
[][]The sampling & testing frequency will be 7 days and 15 days. In addition for blister and filled bottles-60 days study to be performed. Based on the holding time study the holding period will be fixed.
[][]During holding time study all products were considered withstand the controlled environmental condition (The environmental condition is; %RH: NMT 55.0% and Temperature NMT 25deg.C).
[][]If the holding period of dispensed active materials, blended granules, bulk tablets/capsules, filled bottle and blister strips is more than the time period specified in this SOP then further assessment/retesting to be conducted before further proceeding.
[][]However in case of recoverable residue consumption of capsule products the h. study will be conducted up to four months and based on the analytical data the holding period will be fixed.
[][]The numbering of hold time study report for individual products shall be assigned as per
=>HSR/PXXXXX/YY
=>Where, HSR means Hold time Study Report
=>PXXXXX means the product code
=>YY means the version number of the study report.
[][]Sampling, analytical testing shall be conducted according to annexure- I.
[][]Hold time test of dispensed active materials for a product of different strengths will be done once.
[][]Data shall be compiled and used for establishing in-process holding time limits for different stages of product manufacturer.
[][]The H. study for equipment should be performed and both clean and unclean state of equipment also be considered. Based on the documented data the equipment holding time period will be established.
[][]After collecting all data the H. time study report will be generated for each product following the annexure-II.
Annexure:
Annexure-I: Sampling stage and testing frequency for hold time study
Annexure-III: Hold time study Report format