Hold time-1

HOLD TIME STUDY PROTOCOL

OF

CLEANED MANUFACTURING EQUIPMENT

AWAITING FOR USE

COMPANY NAME

DOCUMENT NUMBER :

ISSUE DATE :

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 2 of 11

TABLE OF CONTENTS

1. PREAPPROVAL...................................................................................................................................................03

2. OBJECTIVE....................................................................................................04

3. SCOPE...........................................................................................................04

4. RESPONSIBILITIES.......................................................................................04

5. EXECUTION PLAN….....................................................................................................05

6. DOCUMENTATION OF THE VALIDATION EXPERIMENT..............................................06

7. REVIEW OF TEST RESULTS ........................................................................................08

8. EXECUTIVE SUMMARY................................................................................09

9. REPORT APPROVAL....................................................................................10

10. GLOSSARY....................................................................................................10

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 3 of 11

1.0 PREAPPROVAL: 1

The pre-approval of this Hold Time Study Protocol shall be the joint responsibility of the following:

_______________________________ _____________

DateHead Production

_______________________________ ___________ Date:

Officer Quality Control

_________________________________ ___________ . Date:

Executive Quality Assurance

_______________________________ ___________ Date:

Works Manager

__________________________________ ____________

. Date: Manager – Corporate Quality System

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 4 of 11

2.0 OBJECTIVE:

The protocol is intended to prove with a high degree of confidence, by providing the

suitable documented evidence for hold time study of Cleaned Manufacturing Equipment

awaiting for use.

The cleaned Manufacturing equipments with hold time for minimum 3 days do not have

effect on quality attributes.

3.0 SCOPE

The protocol shall specify the responsibilities for the activities related to Hold Time

Study.

The sampling and testing plan shall explained in this protocol and shall be executed in

order to achieve the objective

4.0 Responsibilities

Quality Assurance:

Quality Assurance (QA) Head is responsible for preparation, checking and approval of

Hold Time Validation protocol. He is also responsible to ensuring execution, verification

of proper sampling and testing activities, and review of study data .He is responsible for

final review and approval of the Hold Time Study report. Quality Assurance Officer is

responsible for sampling of the samples at the specified stages of the study. Quality

Assurance Officer is responsible for recording for temperature and humidity of the

concern area. Executive Quality Assurance is responsible for checking and verification

related to storage conditions monitoring during Hold time.

Quality Control

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 5 of 11

The Quality Control personnel are responsible for testing and release of the samples at

the specified stages of the study.

The Hold Time Study shall comprise of the following team members.

NAME OF PERSON DEPARTMENT DESIGNATION

5.0 EXECUTION PLAN :

Initiation Date : _______________

Completion Date : _______________

Keep aside cleaned manufacturing equipments in clean and dry polybags in a proper place intended for storage. Analyze the manufacturing equipment on 1st day for microbial limit test.

Hold the cleaned manufacturing equipment for a period of 3 days under proper storage conditions.

At the end of 1st day, 2nd day and 3rd day again analyze the manufacturing equipment for microbial limit test and compare the results.

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 6 of 11

5.1 Sampling Plan :Take the swab 100 cm2 of the manufacturing equipment and place it in a sterile tube .

Equipment Sampling Locations

Vibratory Sifter1. Discharge Valve2. Edges of Sieve

Binder Preparation Vessel 1. Bowl of Binder Preparation Vessel

IPC Container 1. Discharge Valve

Saizoner Mixer Granulator1. Base of Chopper2. Base of Mixer

Fluidized Bed Drier

1. Edges of sieve of FBD bowl2. View Glass of Bowl3. View Glass of Body4. Rim of the Sieve of Bowl

Sifter cum Multimill1. Sieve of Sifter2. Sieve of Multimill

Conta Bin 1. Discharge Valve

Tippler 1. Discharge Valve

Compression Machine

1. Hopper 12. Hopper 23. Forced Feeder 14. Force Feeder 25. Turret6. Deduster 17. Deduster 28. Chute

Auto-Coater1. Baffle2. Pan

Coating Solution Preparation Vessel 1. Coating Vessel

Colloidal Mill1.Sieve of Grinding slit2. Hopper

Blister Machine1. Hopper2. Disc3. Nozzle of Hopper

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 7 of 11

Strip Sealing Machine1. Hopper2. Disc3. Nozzle of Hopper

Before taking the swab sampling verify that the equipment is visually clean to the eye and it

should be free from traces of previous product.

Label the samples appropriately after taking the swab.

5.2 Description of the Experiment:

1. Determine the microbial count of the Manufacturing equipment.

5.3 Microbial Procedure:

Sr. No Test Acceptance criteria Reference

1. Visual observation Clean to Eye. Inhouse

2.Microbial Limit Test:Total Aerobic Microbial Count

NMT 100 cfu / 100 cm2 Inhouse

DESCRIPTION OF THE EXPERIMENT:

Carry out a visual inspection & microbiological examination for cleaned manufacturing equipment.The samples should be tested for total microbial count as a microbiological examination.

6.0 DOCUMENTATION OF THE VALIDATION EXPERIMENT

Sampling details and microbiological results of the validation experiment are documented respective protocol.

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 8 of 11

7.0 REVIEW OF TEST RESULTS:

The following table summarizes of visual inspection & microbiological examination

manufacturing equipment for hold period time of 3 days.

Equipments after Cleaning and Awaiting for Use

Manufacturing Equipments

( Meets Acceptance Criteria Yes / No )

SUMMARY OF VISUALINSPECTION

SUMMARY OF MICROBIO –LOGICAL EXAMINATION

INITIALDAY

1st DAY

2nd

DAY3rd

DAYINITIAL

DAY1st

DAY2nd

DAY3rd

DAY

Vibratory Sifter

Binder Preparation Vessel

IPC Container

Saizoner Mixer Granulator

Fluidized Bed Dryer

Sifter cum Multimill

Conta Bin

Tippler

Compression Machine

Auto-Coater

Coating Solution Preparation Vessel

Colloidal Mill

Blister Machine

Strip Sealing Machine

Reference Report No.:

Report No.:

Report No.:

Report No.:

Report No.:

Report No.:

Report No.:

Report No.:

Date

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 9 of 11

Remark:

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

Checked By: ________________________ Date: ___________________

Reviewed By: ________________________ Date: ___________________

8.0 EXECUTIVE SUMMARY:

Note: Use additional pages if required.

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

______________________________________________________________________

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

Protocol No. : XXXXXXXX Issue Date : XXXXXXXVersion No : 00 Page No. : Page 10 of 11

______________________________________________________________________

Written By: ________________________ Date: ___________________

Approved By: ______________________ Date: ___________________

9.0 REPORT APPROVAL:

_______________________________ ___________

DateHead Production

_______________________________ ___________

Date:Officer Quality Control

_________________________________ ___________

Date:Executive Quality Assurance

_______________________________ ___________

. Date:Works Manager

__________________________________ ____________ Date:

Manager – Corporate Quality System

10.0 GLOSSARY:

GLOSSARY CFU’S Colony Forming Units

cm Centimeter

CME Cleaned Manufacturing Equipment

HTS Hold Time Study

QA Quality Assurance

QC Quality Control

HOLD TIME STUDY PROTOCOL OFCLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

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