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