5.1 Preparation of the Hold time study Protocol: 
5.1.1 Protocol for hold time study shall be prepared based on the technology transfer documents and manufacturing process. 
5.1.2 Protocol shall be prepared as per the “Template for preparation of protocol” and may consist of the following but not limited to:
5.1.2.1 Table of Contents
5.1.2.2 Protocol Approval
5.1.2.3 Objective.
5.1.2.4 Function and Responsibility.
5.1.2.5 Product description.
5.1.2.6 Procedure.
5.1.2.7 Compilation Review and Preparation of Hold time study Report.
5.1.2.8 Abbreviation
5.1.2.9 Annexure for data compilation.
5.2 Hold time studies will be carried out on any one or three batch of process optimization / submission / validation batches.
5.3 Hold time studies for sterile articles will be carried out during media fill.
5.4 In process hold time study will be carried out to study the stability of product from samples collected at various stages of (binder solution, granulation wet mass, blend, core tablets, coated tablets, coating solution, filled capsules manufacturing, filtered solution, manufacturing bulk etc.)
5.5 Collect the hold time study sample which is double the quantity of sample required for analysis.
5.6 Hold time sample shall be collected and preserved in double layered poly bags and or SS container and controlled at 23±2 ºC or at the temperature specified for the product.
5.7 The sample collected for hold time studies will be submitted for analysis to QC as per the sampling plan given in hold time study protocol along with test request form.
5.8 Hold time study sample shall be analyzed as per respective test procedures.
5.9 Quality assurance shall prepare the hold study time protocol for various stages of manufacturing as per “Template for preparation of protocol”
5.10 An annexure shall be prepared to each protocol for compilation of results and record the observation in the annexure.
5.11 After analysis of hold time samples, the results / observation shall compile in the respective annexure (Recording of observation) of the protocol.
5.12 Report shall be prepared by QA personnel as per “Template for preparation of report” and forward to concern departmental heads or their designees for review.
5.13 After review, Head QA or their designee should approve Hold time study reports.
5.14 QA personnel shall enter the Hold time study Protocol / report number as per “Template For Validation Protocol/Report Numbering Register”.
5.15 Revalidation:
5.15.1 Revalidation shall be carried out in any of the following circumstances.
5.15.2 Modification of the manufacturing formula for the product and alterations to the procedure or the quality of raw materials.
5.15.3 Change of equipment, installation of new equipment, major changes in the machinery or apparatus and breakdowns.
5.15.4 Major changes in process parameters.
5.15.4.2 On appearance of negative quality trends.
5.15.4.3 Change in storage condition
5.16 Hold time Study protocol and Hold time Study report Numbering system:
5.16.1 QA department shall assign the hold time study protocol / report numbers and record the same in “Template For Validation Protocol/Report Numbering Register”.
5.16.2 This is a unique number given to each Hold time study protocol and its corresponding report(s) as per “Template For Protocol / Report Numbering System”.
5.17 Product shall be referred from respective batch manufacturing record.