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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5737_Библиотеки_им_академика_М_И_Перельмана
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149Qualication and Its Segments
ATTACHMENT I
IQ Data Sheets - Instrument Calibration Program
Critical Process Instruments
List all process instrumentation requiring calibration.
Prepared By: Date:
Reviewed By: Date:
Instrument Type
Manufacturer
Serial Number
Model Number
Equipment Tag ID
Calibration Tag ID
Calibration Frequency
Pre-OQ Calibration Date
Post OQ Calibration Date
Instrument Type
Manufacturer
Serial Number
Model Number
Equipment Tag ID
Calibration Tag ID
Calibration Frequency
Pre-OQ Calibration Date
Post OQ Calibration Date
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150 Basics of Pharmaceutical Manufacturing and Quality Operations
ATTACHMENT I
IQ Data Sheets - Instrument Calibration Program
Not for Calibration Instrumentation
List all process instrumentation which does not require calibration.
IQ Data Sheets - Lubricants
In Product/Critical Component Surface Contact
List all lubricants that come in product contact or in contact with critical components.
Type Manufacturer / Model
Prepared By: Date:
Reviewed By: Date:
Name Description Used For
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151Qualication and Its Segments
ATTACHMENT I
IQ Data Sheets–Lubricants
Not In Product/Critical Component Surface Contact
List lubricants that do not come in product contact.
ATTACHMENT I
IQ Data Sheets
Engineering Drawings
Identify engineering drawings that are associated with the equipment being
validated
Controls, Alarms and Interlocks
Identify controls, alarms and interlocks that are associated with the item being
validated.
Enter the name of the control, alarm or interlock in “Name”, describe what it
does in “Function Description” and specically identify its physical location in
“Location”. Include asset numbers or instrument IDs in “Name”.
Prepared By: Date:
Reviewed By: Date:
Name Description Used For
Drawing # and
Storage Location Title Rev. # Date
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152 Basics of Pharmaceutical Manufacturing and Quality Operations
ATTACHMENT I
IQ Data Sheets
Initial Cleaning
Describe and document all cleaning activities required to make this item ready
for service.
1. Initiate the OQ Protocol for a manufacturing equipment.
Answer:
Completion of the following signature block signies that the appropriate parties
have reviewed this validation protocol and agree with the methodology and accep-
tance criteria. A complete report with will be issued for separate approval.
Protocol Aut h or: ________________________ Date: ____________
Prepared By: Date:
Reviewed By: Date:
Title
Purpose
Equipment
Process/Product
Component
Location
Department
Documents Included
Prepared By: Date:
Reviewed By: Date:
Name Function Description Location
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153Qualication and Its Segments
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 Equipment and Operations
2.1 Process Equipment Studied
2.2 Critical Parameters
2.3 Critical Results
2.4 Apparatus, Equipment and Raw Materials Required
2.5 Calibrations
3 Responsibilities
3.1 Validation
3.2 Operations
3.3 Engineering
3.4 Quality Assurance
3.5 Regulatory Compliance
3.6 Technical Development
4 Sample Handling and Laboratory Results
4.1 Sample Identication and Labels
4.2 Laboratory Requirements
4.3 General
5 Evaluations
5.1 Evaluation 1
Attachments
Attachment 1- Sample Evaluation Summary
Attachment 2- Resolution of Problem Form
Name/Title Signature Date
Manager Validation
Manager Engineering
Manager Quality Operations
Director Quality Assurance
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154 Basics of Pharmaceutical Manufacturing and Quality Operations
1 INTRODUCTION
1.1 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.
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. Like:
• Electric pump to transfer water in manufacturing.
•
Jacketed stainless steel pressure vessel for boiling water in manufacturing
process.
•
Clean steam generator to convert Puried Water, USP into clean steam
using plant steam as the heat source. Attached to uid bed dryers.
1.2 PurPose
Describe the purpose of the validation program, why it is required and how it will
affect the business.
1.3 scoPe
Describe where this work applies (like a specic facility) or a set of specic condi‑
tions (like when a specic process condition occurs). Precisely dene the equipment,
system, process or product affected by the work
1.4 references
Validation SOP# ABC123 “Validation Program”
List appropriate local policies, SOPs, procedures or other documents that are
affected by this study or the item being studied.
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155Qualication and Its Segments
1.5 excePtionaL conditions and deviations
Any minor changes or deviations that are necessary to comply with this protocol will
be documented in the nal report. Any signicant changes or deviations altering the
scope or intent of this protocol require prior approval by the original signatories and
documentation in the nal report.
This section insures that there is a mechanism for handling unforeseen events. It
permits the study to continue if minor changes in the validation program or accep‑
tance criteria are required.
1.6 vaLidation aPProach
Describe the basic approach to validating this item. Mention general procedures,
evaluations and methods that will be employed. Explain how this approach charac‑
terizes the operation of the item.
2 EQUIPMENT AND OPERATIONS
Specically dene all items affected by and included in the validation.
2.1 Process eQuiPMent studied
2.2 criticaL ParaMeters
This is a subset of all the process control parameters. It includes only the parameters
that are directly responsible for product quality. For example, it might include mix‑
ing time, air temperature or machine speed. It might not include line voltage or room
positive pressure differential.
2.3 aPParatus, eQuiPMent and raW MateriaLs reQuired
List all items required to perform the validation program other than the equipment
being studied. This list would include: validation instruments, packaging compo‑
nents and process raw materials.
2.4 caLibrations
The following items require calibration to support this study:
Process Equipment
Process Instruments
Validation Instruments
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156 Basics of Pharmaceutical Manufacturing and Quality Operations
Note any and all calibration requirements. Process equipment, process instrumenta‑
tion, validation equipment, validation instruments, laborator y instruments, as required.
Calibration certicates or other evidence that the instruments were in calibration
at beginning and end of this study will be provided in the validation report.
3 RESPONSIBILITIES
List all departments that will be involved in the validation program and specically
describe their responsibilities.
3.1 vaLidation
Prepare validation protocol
Perform the OQ study and prepare the nal report
Review and approve validation protocol and report
3.2 oPerations
Review and approve validation protocol and nal report
Provide trained operators and other required resources to properly run necessary
equipment
3.3 enGineerinG
Review and approve validation protocol and nal report
Provide engineering and design specications for the associated systems and
equipment
3.4 QuaLity assurance
Review and approve validation protocol and nal report
3.5 reGuLatory coMPLiance
Review and approve validation protocol and nal report
3.6 technicaL deveLoPMent
Provide laboratory services for evaluation samples
Review and approve validation protocol and nal report
4 SAMPLE HANDLING AND LABORATORY RESULTS
Describe how samples will be identied and labeled. If necessary describe speci‑
cally which laboratories will handle which samples. Describe any on routine sample
handling requirements like “Hold under refrigeration or up to 24 hours”.
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157Qualication and Its Segments
4.1 saMPLe identification and LabeLs
Each evaluation sample is assigned a unique identication number. The sample is
described on the “Sample Evaluation Summary” in Attachment 1. The sample ID
and evaluations required are transferred to the sample’s label and recorded by the
laboratory staff in their laboratory notebooks with the evaluation results.
The person taking the sample is responsible for; properly completing the “Sample
Evaluation Summary”; preparation of a corresponding label; attaching the label to
the sample and sample submission to the laboratory.
4.2 Laboratory reQuireMents
Perform all analysis per approved SOPs and validated analytical methods. Record
results in laboratory notebooks referenced to Sample ID and Study Number. Provide
copies of laboratory notebook pages or an ofcial summary form to validation.
Describe how laboratory results will be recorded and reported. Specic forms
may be referenced in the Evaluations section.
4.3 GeneraL
All data sheets and test results will be signed by appropriate validation personnel,
analytical personnel and or process operators involved in this study, as required.
5 EVALUATIONS
Describe the planned evaluations and associated acceptance criteria.
5.1 evaLuation 1
Objective
Describe the reason this evaluation is being performed and what it reveals about
the item being evaluated.
The way the evaluation will be performed is described in Methodology.
Methodology
Describe how samples will be taken including the sampling interval and where in
the process samples will be taken from.
Identify specic evaluation methods either via an approved procedure or
describe the procedure in full detail. If required describe how to dispose of samples
afterwards.
Reference data sheets in Attachments if they are required.
Acceptance Criteria
List the specic acceptance criteria for this evaluation.
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158 Basics of Pharmaceutical Manufacturing and Quality Operations
ATTACHMENT 1
SAMPLE EVALUATION SUMMARY
Sample Evaluation Summary
Data By: Date:
Review By: Date:
Sample Description Sample ID
Batch ID .
Drum ID
Evaluation or Assay Required Sample Date
Sample Time
Sampled By
Sample Location Acceptance Criteria
Comments Lab Results
Sample Description Sample ID
Batch ID .
Drum ID
Evaluation or Assay Required Sample Date
Sample Time
Sampled By
Sample Location Acceptance Criteria
Comments Lab Results
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