HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE

COMPANY NAME

DOCUMENT NUMBER ISSUE DATE

: :

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 TABLE OF CONTENTS Issue Date : XXXXXXX Page No. : Page 2 of 11

1. PREAPPROVAL............................................................................................03
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1.0

PREAPPROVAL:

000000001 The pre-approval of this Hold Time Study Protocol shall be the joint responsibility of the following:

_______________________________ Head Production

_____________ Date

_______________________________

___________

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 3 of 11
Date:

Officer Quality Control

_________________________________ . Executive Quality Assurance

___________ Date:

_______________________________ Works Manager

___________ Date:

__________________________________ . Manager Corporate Quality System

____________ Date:

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

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 4 of 11

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 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

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 5 of 11

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.

5.1 Sampling Plan : Take the swab 100 cm2 of the manufacturing equipment and place it in a sterile tube . Equipment Vibratory Sifter Binder Preparation Vessel IPC Container Saizoner Mixer Granulator Sampling Locations 1. Discharge Valve 2. Edges of Sieve 1. Bowl of Binder Preparation Vessel 1. Discharge Valve 1. Base of Chopper 2. Base of Mixer

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 6 of 11 1. Edges of sieve of FBD bowl 2. View Glass of Bowl 3. View Glass of Body 4. Rim of the Sieve of Bowl 1. Sieve of Sifter 2. Sieve of Multimill 1. Discharge Valve

Fluidized Bed Drier Sifter cum Multimill Conta Bin Tippler

1. Discharge Valve 1. Hopper 1 2. Hopper 2 3. Forced Feeder 1 4. Force Feeder 2 Compression Machine 5. Turret 6. Deduster 1 7. Deduster 2 8. Chute 1. Baffle Auto-Coater 2. Pan Coating Solution Preparation Vessel 1. Coating Vessel 1.Sieve of Grinding slit Colloidal Mill 2. Hopper 1. Hopper Blister Machine 2. Disc 3. Nozzle of Hopper 1. Hopper Strip Sealing Machine 2. Disc 3. 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 1. 5.3 Sr. No 1. Description of the Experiment: Determine the microbial count of the Manufacturing equipment. Microbial Procedure: Test Visual observation Acceptance criteria Clean to Eye. Inhouse Reference

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Microbial Limit Test: Total Aerobic Microbial Count Issue Date : XXXXXXX Page No. : Page 7 of 11

2.

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 OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX 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 ( Meets Acceptance Criteria Yes / No ) Manufacturing Equipments 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 Date Report No.: Report No.: Report No.: Report No.: Report No.: Report No.: Report No.: Report No.: SUMMARY OF VISUAL INSPECTION
INITIAL DAY 1st DAY 2nd DAY 3rd DAY

SUMMARY OF MICROBIO LOGICAL EXAMINATION

INITIAL DAY 1st DAY 2nd DAY 3rd DAY

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX 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 OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 10 of 11

______________________________________________________________________ Written By: ________________________ Approved By: ______________________ 9.0 REPORT APPROVAL:
_______________________________ Head Production _______________________________ Officer Quality Control _________________________________ Executive Quality Assurance _______________________________ Works Manager . ___________ Date

Date: ___________________ Date: ___________________

___________ Date:

___________ Date:

___________ Date: ____________ Date:

__________________________________ Manager Corporate Quality System

10.0 GLOSSARY: GLOSSARY CFUS cm CME HTS QA QC Colony Forming Units Centimeter Cleaned Manufacturing Equipment Hold Time Study Quality Assurance Quality Control

HOLD TIME STUDY PROTOCOL OF CLEANED MANUFACTURING EQUIPMENT AWAITING FOR USE Protocol No. : XXXXXXXX Version No : 00 Issue Date : XXXXXXX Page No. : Page 11 of 11