Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5737_Библиотеки_им_академика_М_И_Перельмана
.pdf
139Qualication and Its Segments
QUESTIONS AND ANSWERS
1. Dene qualication
Answer: Qualication can be dened as the process of establishing docu-
mented evidence to ensure that a specic equipment, facility or system are t
and ready for their intended use. Equipment qualication can also be dened
as the activities in which various inspections, tests, and assessments of the
entire system are performed to ensure that a given piece of equipment is com-
pliant and ensures reliable performance. It further conrms that the equip-
ment will continue to do, on a consistent basis, what it is supposed to do.
2. How many stages of qualication are there?
Answer: There are four stages of qualication that help determine if the
process being tested is capable of operating in its specic environment.
These stages are:
• Design Qualication (DQ)
• Installation Qualication (IQ)
• Operational Qualication (OQ)
• Performance Qualication (PQ)
3. What is the difference in validation, verication and qualication?
Answer: Validation is a process or instance to support a system or process
on a sound authoritative basis that the specied requirements for a spe-
cic intended use or application have been fullled. Whereas verication is
the process of establishing the reality of a system through the provision of
objective evidence that the specied requirements have been fullled. For
example, comparison of a new design specication with a similar proven
design specication. Qualication differs from validation and verication
in terms of the nature of the process that is executed to assure that a system
under question complies with specic requirements. Qualication can con-
cern persons, products, processes or systems.
4. What is the denition of performance qualication?
Answer: Performance qualication is dened by FDA as “Establishing
condence through appropriate testing that the nished product or process
produced by a specied process meets all release requirements for function-
ality and safety and that procedures are effective and reproducible”.
Performance qualication is the executed test protocol documenting
that a system meets the dened requirements to function in the production
environment.
5. What is a qualication protocol intended for?
Answer: An approved qualication protocol is required to dene the test
cases that will be used to verify the proper functioning of a system. The
qualication protocol has to be approved before execution where all parties
agree on the test requirements given in the protocol
https://t.me/med1917
140 Basics of Pharmaceutical Manufacturing and Quality Operations
6. Describe briey the general rules that should be looked into before
installation of an equipment?
When installing a new equipment, basic safety precautions should be fol-
lowed to reduce the risk of re, electric shock and personal injury including
the following:
1. The machine/system must be operated by person(s) familiar with the
respective process and technology.
2. Always refer to the layout/assembly drawing for the approximate weight
of the machine.
3. Know the rating of the area where the machine is to be used and consult
the specications and layout drawing for rating of electrical components
and location of sub-systems.
4. All electrical connections must be made by a qualied electrician and
must conform to local electrical codes and grounding practices.
5. Before connecting the machine to a power source, be sure that the volt-
age supply is the same as specied on electrical components.
6. Use the stop button to stop the machine and wait for rotating parts (if
any) to come to a complete stop.
7. Ensure that interlock switches are working correctly prior to using the
machine.
8. Lock out power before opening, adjusting, cleaning, servicing and chang-
ing parts.
7. Initiate an installation qualication protocol for a Production equipment.
Answer: The installation qualication protocol is generated as follows:
Completion of the following signature block signies that the appropriate
parties have reviewed this installation qualication report and agree that it
is correct and complete.
Title
Purpose
Equipment
Process/Product
Component
Location
Department
Documents Included
https://t.me/med1917
141Qualication and Its Segments
Proto col Autho r: ________________________ Date: ____________
TABLE OF CONTENTS
Title Page
Table of Contents
1. Introduction
1.1 Ba ckg round
1.2 Purpose
1.3 Scope
1.4 Referenc es
1.5 Exceptional Conditions and Deviations
1.6 Validation Approach
2. Evaluations
2.1 Gene ral
2.2 Equipment and System Utilities
2.3 Operation and Maintenance Program
2.4 Instrument Calibration Program
2.5 Lubricants
2.6 Engineering Drawings
2.7 Controls, Alarms, and Interlocks
2.8 Initial Cleaning
Attachments
Attachment 1
Attachment 2
1 INTRODUCTION
1.1 PurPose
Installation qualication identies an item or system, how it was actually installed
and what SOPs will be used to operate and maintain it in the operations environment
1.2 backGround
The reader needs to know what is being qualied, how it will be used, why it was
selected for this service and where it will be used. One or two paragraphs should sufce.
Reviewer and Approvers
NAME/TITLE Signature Date
Manager
Validation
Manager Engineering
Manager Quality Assurance
Director Quality Operations
https://t.me/med1917
142 Basics of Pharmaceutical Manufacturing and Quality Operations
This description may include (but is not limited to):
• Equipment name and model
• Basic capacity and ratings
• Fixed or portable operation
• New or used equipment (with previous use)
• Planned use
• Why this item was selected for this service and why we feel that it will meet
our needs
• Why the item requires validation
This section should include a basic description of the equipment and its intended
use. Some examples are as follows:
• Electric pump to transfer water in manufacturing.
• Jacketed stainless steel pressure vessel for boiling water in the process.
• Clean steam generator to convert Puried Water, USP into clean steam
using plant steam as the heat source. Attached to uid bed dryers.
1.3 Scope
1.4 Referenc es
1.5 Exceptional Conditions and Deviations
1.6 Validation Approach
2 EVALUATIONS
2.1 GeneraL
Complete data sheets in ATTACHMENT I including:
Equipment and System Description
Manufacturers Specications
Purchase Orders
Materials in Product Contact
2.2 eQuiPMent and systeM utiLities
Complete data sheets in ATTACHMENT I corresponding with the applicable items
below.
https://t.me/med1917
143Qualication and Its Segments
2.3 oPeration and Maintenance ProGraM
Complete data sheets in ATTACHMENT I including:
Equipment Operation Documents
Equipment Maintenance Documents
Equipment Sanitation Documents
2.4 instruMent caLibration ProGraM
Complete data sheets in ATTACHMENT I including:
Critical Process Instruments
Not for Calibration Instruments
2.5 Lubricants
Complete data sheets in ATTACHMENT I including:
In Product/Critical Component Surface Contact
Non In Product/Critical Component Surface Contact
2.6 enGineerinG draWinGs
Complete data sheets in ATTACHMENT I including:
Engineering Drawings
2.7 controLs, aLarMs and interLocks
Complete data sheets in ATTACHMENT I including:
Controls, Alarms and Interlocks
2.8 initiaL cLeaninG
Complete data sheets in ATTACHMENT I including:
Initial Cleaning
Applicable Not Applicable
Electrical
Plant Steam
Gasses
Oil Free Compressed Air
Compressed Air
Utility Heated Water
Cooling Water
Potable Water
Puried Water
Clean Steam
House Vacuum
https://t.me/med1917
144 Basics of Pharmaceutical Manufacturing and Quality Operations
ATTACHMENT I
IQ Data Sheets
ATTACHMENT I
IQ Data Sheets–General
Equipment and System Description
Identify and document all equipment associated with the system undergoing IQ.
Add additional pages if necessary. Make more tables like the following for all associ-
ated equipment.
Work Orders
Identify all work orders associated with the system.
ATTACHMENT I
Manufacturers Specications
Manufacturer
I. D. Number
Serial Number
Model Number
Location
Completed
By/Department Name WO # Description
Prepared By: Date:
Reviewed By: Date:
Document where specications associated with the system being
validated documents are led. Description
Location
https://t.me/med1917
145Qualication and Its Segments
Materials in Product Contact
List all materials in the equipment that come into product contact:
IQ Data Sheets - Equipment and System Utilities
Electrical
Identify and document the installation’s electrical requirements and the specic
connections to the facility electrical supply.
Equipment Description
Service Requirements Actual Supply
Safety Features
Part Material
Prepared By: Date:
Reviewed By: Date:
Voltage
Phase
Amperage
Frequency
Circuit Breaker Installed
Amperage Rating
Circuit Breaker Location
Circuit Breaker and Controls Properly Identied
Other Electrical Safety Devices
https://t.me/med1917
146 Basics of Pharmaceutical Manufacturing and Quality Operations
Supply Wiring Requirements Actual
ATTACHMENT I
IQ Data Sheets–Equipment and System Utilities
Gasses
Describe the source and connections of gasses used in manufacturing processes
to the installation.
Source System Description
Required Supply Characteristics
Actual Supply Characteristics
Local Drop
Prepared By: Date:
Reviewed By: Date:
System Description
Gas Type and Specication
Validation Study ID (If Validated)
Piping Material
Supply Valve ID
Flow Rate or Pipe Size Specied
Pressure Range Specied
Flow Rate or Pipe Size
Pressure Range
Piping Material
Dead Legs
Conductor Type
Conductor Size
Properly Grounded
https://t.me/med1917
147Qualication and Its Segments
Filters
Make more tables on next pages with one each for the following system utili‑
ties since the description for these systems will remain system.
Plant Steam
Oil Free Compressed Air
Compressed Air
Potable or Utility Water
Chilled Water
Clean Steam
House Vacuum
ATTACHMENT I
IQ Data Sheets–Equipment and System Utilities
Puried Water
Describe the source water system and its connections to the installation.
Source System
Required Supply Characteristics
Filter Type Manufacturer Model Porosity Location
Bldg./Room
Change
Frequency
Prepared By: Date:
Reviewed By: Date:
System Description
Validation Study ID (If Applicable)
PW Type (WFI, USP, DI, RO, etc.)
Hot or Cold Supply/Supply Temperature
Supply Piping Material
Most Recent Date Tested and Results
Supply Valve ID and Location
Flow Rate or Pipe Size Specied
Pressure Specied
Temperature Range Specied
https://t.me/med1917
148 Basics of Pharmaceutical Manufacturing and Quality Operations
Actual Supply Characteristics
Local Drop
ATTACHMENT I
IQ Data Sheets - Operation and Maintenance Program
Equipment Operation Documents
List SOPs, manuals and logs that are associated with operation of the system.
Make simila r tables to list the SOPs, manuals and logs associated with Maintenance
of the system and with cleaning, sanitation and sterilization of the system.
Flow Rate or Pipe Size
Pressure
Temperature Range
Piping Material
Dead Legs
Prepared By: Date:
Reviewed By: Date:
Document Number Document Title Revision
Prepared By: Date:
Reviewed By: Date:
https://t.me/med1917
Соседние файлы в папке Библиотека им академика М.И. Перельмана