Hold Time Study Report Template of Dispensed Raw Material

REPORT ON HOLD TIME STUDY OF DISPENSED RAW MATERIAL
Location
Ref. Protocol No.
Technical Manufacturing Document Reference No.
Report contains pages

TABLE OF CONTENT

Sr. No.	Subject	Page No.
1	Report Approval Sheet
2	Objective
3	Scope
4	Validation Team
5	Responsibility
6	Procedure
7	Acceptance criteria
8	Annexure – 1
9	Summary, Conclusion & Approval Report

REPORT APPROVAL SHEET

	Prepared By	Checked By	Approved By
Signature
Name
Date
Department	Microbiologist	QC – Head	QA – Head

OBJECTIVE

The objective of this report is to establish the holding period for dispensed raw material of a batch with respect to the quality of the raw material.

ALSO READ: Process Validation Protocol for Parenteral

SCOPE

The report describes the responsibility, procedure for hold time study of the dispensed raw material, acceptance criteria, summary & approval report.

VALIDATION TEAM

A representative from each of the following departments:

• Microbiologist
• Production Officer
• I.P.Q.An Officer

RESPONSIBILITY

• Microbiologist:  To study the bio-burden load in the product according to the laid down procedure and to prepare the report for the batch under study.
• Quality Control – Head: To check the report.
• Quality Assurance – Head: To review & approve the report.

PROCEDURE

• Dispense the batch of Oral Suspension for hold time study of dispensed material.
• Select the ingredient which is maximum susceptible to microbial growth for the hold time study.
• Collect samples of the selected ingredient for microbial analysis as per the sampling plan.
• Sampling Plan

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• Perform microbial analysis of the test samples as per SOP.
• Record the results in Annexure – 1.

ACCEPTANCE CRITERIA

Microbial Limits

1. Total Bacterial Count: Not more than 1000 CFU/gm
2. Total Fungal Count: Not more than 100 CFU/gm
3. Pathogens ( E.coli, Salmonella typhi): Absent

ANNEXURE

SUMMARY

1. The study for establishing the hold time period for dispensed raw material was carried out in accordance with the procedure in the protocol.  
2. There was no considerable increase in the bacterial & fungal count of sucrose in first three days of the study.
3. There was an increase in the bacterial & fungal counts of sucrose after the fourth day of the study, which however were observed within the acceptable limits.
4. There was a considerable decrease in the microbial count of sucrose analyzed after drying it on the eighth day of the study.

 

CONCLUSION

From the study carried out, a hold time period of seven days for dispensed raw material has been established.

Checked By	Approved By
Quality Control – Head	Quality Assurance – Head

ALSO READ: Hold Time Study Protocol