The document provides an overview of validation requirements in the pharmaceutical industry. It defines key terms like process validation, cleaning validation, and maximum allowable carryover. It describes the importance of validation in assuring quality and reducing costs. The document outlines the various stages of validation including process design, qualification, and continuous verification. It emphasizes that validation is an ongoing process to demonstrate consistency. Key aspects that must be addressed in a validation program are also summarized such as personnel training, change control procedures, and documentation.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
This document provides an overview of validation requirements in the pharmaceutical industry. It begins with definitions of validation from FDA guidelines in 1987 and 2011. Validation originated in the 1970s focused on sterilization, and has now expanded to all product, process, and facility matters. Validation is required to assure quality, is a regulatory requirement, and reduces costs. The stages of validation for a product and process are outlined, including process design, process qualification, and continuous process verification. Key aspects of validation like process validation, change control, and documentation are also summarized.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and discusses where the concept came from and why it is important. Validation helps ensure quality, reduces costs, and is a regulatory requirement. The document outlines various qualification stages including design qualification, installation qualification, operational qualification, and performance qualification. It provides details on what each stage involves and key parameters to test at each stage to ensure processes and equipment are functioning as intended.
Validation is a key process for ensuring quality in the pharmaceutical industry. It involves establishing documented evidence that a specific process or equipment will consistently produce a product meeting predetermined specifications. There are three main phases of validation: installation qualification, operational qualification, and performance qualification which are used to demonstrate a process can repeatedly produce the desired product results. Analytical method validation also plays an important role in demonstrating test methods are suitable for their intended use in supporting drug identity, strength, quality and purity. Proper documentation and management of calibration processes are important aspects of validation.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
The document discusses process validation in the pharmaceutical industry. It begins by defining process validation as establishing evidence through documentation that a process is capable of consistently producing a product meeting predetermined specifications and quality attributes. It then describes the three stages of process validation: process design, process qualification, and continued process verification. The document provides details about each stage and emphasizes that process validation is important for assuring pharmaceutical product quality since end product testing alone is not sufficient. It concludes by stating that if each step of production is validated, the final product quality can be assured.
validation is a technique of validating the final product either starting from the raw material or within the process, its all types cover the methods of validation and sequence in the product development.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and traces its origins back to the 1970s where it began with sterilization processes and has now expanded to all product, process, and facility matters. Validation is important as it assures quality, is a regulatory requirement, reduces costs, and is legally required. The document outlines the various stages of validation from user requirement specification to process validation and continuous process verification. It provides details on what each stage involves and its goals.
This document provides an overview of validation requirements in the pharmaceutical industry. It begins with definitions of validation from FDA guidelines in 1987 and 2011. Validation originated in the 1970s focused on sterilization, and has now expanded to all product, process, and facility matters. Validation is required to assure quality, is a regulatory requirement, and reduces costs. The stages of validation for a product and process are outlined, including process design, process qualification, and continuous process verification. Key aspects of validation like process validation, change control, and documentation are also summarized.
The document provides an overview of validation requirements in the pharmaceutical industry. It defines validation and discusses where the concept came from and why it is important. Validation helps ensure quality, reduces costs, and is a regulatory requirement. The document outlines various qualification stages including design qualification, installation qualification, operational qualification, and performance qualification. It provides details on what each stage involves and key parameters to test at each stage to ensure processes and equipment are functioning as intended.
Validation is a key process for ensuring quality in the pharmaceutical industry. It involves establishing documented evidence that a specific process or equipment will consistently produce a product meeting predetermined specifications. There are three main phases of validation: installation qualification, operational qualification, and performance qualification which are used to demonstrate a process can repeatedly produce the desired product results. Analytical method validation also plays an important role in demonstrating test methods are suitable for their intended use in supporting drug identity, strength, quality and purity. Proper documentation and management of calibration processes are important aspects of validation.
This document discusses process validation in the pharmaceutical industry. It defines process validation and describes it as having three stages: process design, process qualification, and continued process verification. The objectives and requirements of each stage are explained. Process validation helps ensure a process consistently produces products meeting specifications and quality attributes. It involves understanding and controlling sources of variation. Validation protocols, reports, teams, and the lifecycle are also reviewed to explain how process validation is planned and documented.
Validation ( process validation, TT from R&D to pilot plant)RushikeshPalkar1
The document discusses process validation in the pharmaceutical industry. It begins by defining process validation as establishing evidence through documentation that a process is capable of consistently producing a product meeting predetermined specifications and quality attributes. It then describes the three stages of process validation: process design, process qualification, and continued process verification. The document provides details about each stage and emphasizes that process validation is important for assuring pharmaceutical product quality since end product testing alone is not sufficient. It concludes by stating that if each step of production is validated, the final product quality can be assured.
Validation is an essential part of good manufacturing practices in the pharmaceutical industry to ensure products are safe and effective. There are several types of validation including prospective validation during development, concurrent validation during production, and retrospective validation reviewing past data. Key aspects of validation include design qualification to ensure proper design, installation qualification confirming proper installation, and operational qualification to establish equipment operates as intended. The overall goal is to scientifically prove processes consistently produce quality products meeting specifications.
Validation is required by the FDA to demonstrate that pharmaceutical manufacturing processes and equipment consistently produce quality products meeting specifications. It involves establishing documented evidence through qualification protocols that address installation, operation, and performance of processes and systems. The goals of validation are to prove quality, functionality, and reproducibility and provide high assurance that specific processes and equipment reliably produce the intended results. Pharmaceutical companies must conduct validation according to FDA guidelines tailored to their unique systems and operations.
Process validation involves three key stages:
1) Process design to define the commercial manufacturing process based on development and scale-up.
2) Process qualification to evaluate the design and determine if reproducible commercial manufacturing is possible.
3) Continued process verification to ensure the process remains in control during routine production through monitoring and adjustment.
Qualification and Validation have big Weightage in the Regulatory Compliance and GMP. Qualification and Validation only can guarantee about the Product Safety, Integrity, Strength, Purity and Quality assurance.
The document discusses pharmaceutical validation, including its history, purpose, and key aspects. It provides definitions for validation, describing it as demonstrating and documenting that a process will consistently produce the expected results. The summary is as follows:
Validation aims to ensure quality is built into pharmaceutical systems and processes at every step. It includes qualification of equipment and facilities. Key parts of validation include process design, qualification, and continued verification to maintain process control. Validation is required by regulations and improves quality, efficiency and compliance for the pharmaceutical industry.
This document discusses validation, including definitions, purposes, types, and processes. It provides details on:
1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
2. Validation is important for new processes and equipment, changes to existing processes/equipment, and where product testing alone cannot ensure quality. It occurs in three phases: pre-validation qualification, process validation, and validation maintenance.
3. A validation master plan is a comprehensive document that describes validation requirements for a facility and provides a validation plan. It covers qualifications, personnel, schedules, and documentation for the validation process.
This document provides an overview of validation in the pharmaceutical industry. It discusses the concepts, types, elements and phases of validation including design qualification, installation qualification, operational qualification, performance qualification and process validation. Validation is required to ensure manufacturing processes are capable of consistently producing quality products and involves establishing documented evidence through qualification and monitoring activities. The document outlines the key principles and guidelines for validation as well as the roles and responsibilities of those involved.
The document discusses validation in the pharmaceutical industry. It begins with an introduction to validation and defines it as documented evidence that a process, equipment, or system consistently produces a product meeting its predetermined specifications and quality attributes. It then covers topics such as why validation is needed, elements of validation like process qualification and equipment qualification, validation protocols, and dosage form validation.
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
The document discusses validation in pharmaceutical manufacturing. It defines validation and equipment qualification, which includes design qualification, installation qualification, operational qualification, and performance qualification. The goals of equipment qualification are to ensure equipment works correctly and produces accurate results through documentation and control of any changes. Specific validation processes for an autoclave used in stem sterilization are also outlined.
This document discusses concepts related to validation in the pharmaceutical industry. It begins by defining validation as proving that a process consistently produces the expected results. There are three phases of validation: pre-validation to establish the design; process qualification to evaluate the design; and continued process verification. Validation is important for quality assurance and regulatory compliance. The key types of validation discussed are process validation, cleaning validation, and analytical method validation.
This document provides an overview of process validation according to FDA guidance. It defines process validation as collecting data from process design through commercial production to establish that a process is capable of consistently delivering quality products. The guidance outlines a lifecycle approach with three stages: process design, process qualification, and continued process verification. Process design defines the commercial process based on development knowledge. Process qualification evaluates the design and determines if the process is reproducible. Continued process verification ensures the process remains controlled during routine production. Critical quality attributes and critical process parameters are identified, and control strategies are established.
This document provides an overview of pharmaceutical validation and calibration processes. It discusses the objectives of validation which include reducing regulatory risks and defects. The scope of validation covers analytical, facilities, manufacturing, product design, cleaning, instrumentation, utilities, materials and equipment. A validation master plan outlines the validation strategy and includes qualification methods, personnel responsibilities, schedules, documentation and change control. Similarly, a calibration master plan ensures equipment is routinely calibrated against reference standards to ensure proper performance and measurement traceability.
the various categories of qualifications necessary for Validating an equipment or instrument before & after installation. Those are
DQ(Design Qualification)
IQ(Installation Qualification)
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PQ(Performance Qualification)
Pharmaceutical Validation ( As per M.Pharm 1st sem Syllabus).pptxMariaSaifee
The document discusses pharmaceutical validation, including definitions, types, and elements of validation. It provides definitions of validation from WHO, FDA, and ICH. The main types of validation discussed are process validation (prospective, concurrent, retrospective), analytical method validation, equipment validation (design qualification, installation qualification, operational qualification, performance qualification), and revalidation. The key elements of validation discussed are specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness. Validation is presented as an important part of ensuring consistent and quality pharmaceutical production.
Complete discussion about the Pharmaceutical validation, its types, difference between calibration and validation, validation master & calibration master plan
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1. Validation is the process of proving that any procedure, process, equipment, or system achieves expected results. It involves establishing evidence that quality requirements are fulfilled.
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validationksd-140930004558-phpapp01 (1).pdf
1. Overview of Validation Requirements
in
Pharmaceutical Industry
Kaushik Desai
Chairman,
Industrial Pharmacy Division
Indian Pharmaceutical Association
www.ipapharma.org
1
2. A definition
Where did validation come from ?
Why do it ?
What are the benefits ?
How far do we have to go ?
2
3. “ Establishing the documented evidence which
provides a high degree of assurance that a
specific process will consistently produce a
product of predetermined specifications and
quality attributes.”
(FDA Guidelines 1987)
3
4. “Process validation is defined as the collection
& evaluation of data, from the process design
stage through commercial production, which
establishes scientific evidence that process is
capable of consistently delivering quality
product.”
(FDA Guidelines, 2011)
4
5. “Action of proving, in accordance with the
principles of Good Manufacturing Practice
(GMP), that any procedure, process,
equipment, material, activity or system
actually leads to expected results.”
(EU GMP 1997)
5
6. Began in 1970’s
Originally sterilized based.
Now evolved into all Product, Process and Facility
matters.
6
11. Calibration
Site Acceptance Testing
Operational Qualification
Standard Operating Procedures
Performance Qualification
Process Validation
Change Control
11
12. User Requirement Specification (URS)
A description of the requirements of the facility
(project) in terms of product to be manufactured,
required throughput and conditions in which the
product should be manufactured.
Approved statements prepared by the user which
defines what is required by the project.
12
13. Design Qualification (DQ)
Documented review of the design, at an
appropriate stage in a project, for conformance
to operational and regulatory expectations.
(Note : Not an obligation)
13
14. Impact Assessment
The process of evaluating the impact of the
operating, controlling, alarming and failure
conditions of a system on the quality of a
product
14
15. Factory Acceptance Testing (FAT)
Inspection and static and/or dynamic testing of
systems or major system components to
support the qualification of an equipment
system conducted and documented at a
supplier site.
(Note : Not an obligation)
15
16. Documented verification that all aspects of a facility,
utility or equipment that can affect the product
quality adhere to approved specifications and are
correctly installed.
The process of checking/verifying the installation to
ensure that the critical components meet the
approved specifications and that they are installed
correctly in accordance with design documentation.
16
17. To establish that the critical components are installed
correctly and in accordance with design
documentation requirements (i.e. PO’s, Contracts
etc.), that supporting documentation is in place and of
suitable quality.
To record the checks and verifications for critical
components in Direct Impact Systems.
17
18. Approval Page
Objectives
System Description
Responsibilities
Acceptance Criteria
Engineering Documentation Requirements
Records of Signatures
Qualification Test Equipment/Instrument List
Product Contact Materials Review
Utilities Verification
Control System Verification
18
19. Instrument/Control Devices Verification
Equipment Verification
Piping Installation Verification
Discrepancy/Justification and corrective Action
As built P&I Diagrams
Specifications
Conclusions
References
Modification/ Change Control
Attachments / Appendices
19
20. Parameters
Does the vessel meet the design specification?
Does the agitator assembly meet the design specification?
Is the motor housing earthed?
Is the motor over current device set to correct setting?
Is all the pipe work connected?
Are all instruments installed as per P&I diagram?
Have all the temperature indicators been calibrated?
Is calibration procedure available?
Are operation and maintenance manuals available?
all electrical connections securely and safely fitted?
Is insulation complete?
Is vessel clean and free from dirt?
20
21. After protocol execution is complete and
deviations evaluated, post execution approval
is required.
Requires sign off by original signatories.
IQ execution should be complete and approved
prior to the start of OQ.
21
22. Calibration
Demonstrating that a measuring device
produces results within the specified limits of
those produced by a reference standard over
an appropriate range of measurements.
The devices are normally tagged and
supported by a maintenance procedures.
22
23. Site Acceptance Testing (SAT)
Inspection and dynamic testing of systems or
major system components to support the
qualification of an equipment system
conducted at a client site.
(Note : Not an obligation)
23
24. Documented verification that all aspects of
a facility, utility or equipment that can affect
product quality operate as intended
throughout all anticipated ranges. It is the
process of testing to ensure that individual
components and systems operate as
specified, and how that information is
recorded.
24
25. To establish through documented testing, that all
critical components and direct impact systems are
capable of operating within established limits and
tolerances.
To test parameters that regulate the process or
product quality. To verify the proper operation of
controllers, indicators, recorders, alarms and
interlocks, is performed and documented during the
operational qualification testing.
25
26. Approval page
Pre-requisites
Objectives
System Description
Responsibilities
Acceptance Criteria
Records of signatures
Qualification test Equipment/Instruments list
Alarm and Interlocks test
Operation testing
Capacity testing
Power failure testing
26
27. Sequence testing
Test data sheets
SOP’s
Conclusions
Modification / change control
Discrepancy/Justification and corrective action
Operational Qualification Summary
References
Attachments/Appendices
- Verification of test instruments
- Chart recordings
- P&I diagrams
- Printouts
27
28. Parameters
Have all Installation Qualification been completed for this system?
Is the system clean and free from dirt?
Is the direction of the rotation of agitator correct?
Check the operation of the agitator emergency stop?
Check the operation of all agitator controls, both on the main and local
panels?
Check that the agitator in the vessel free to turn?
Pressurize the vessel and record the pressure drop for 10 min.
Perform a vacuum test and record the vacuum drop.
28
29. Documented verification that all aspects of
a facility, utility or equipment that can
affect the product quality perform as
intended in meeting the predetermined
acceptance criteria.
29
30. To integrate procedures, personnel, systems
and materials to verify that the utility /
environment / equipment / support systems
produces the required output. This output
may be a product contact utility, sterilization
condition or environment.
30
31. Approval page
Pre-requisites
Objectives
System Description
Responsibilities
Acceptance Criteria
PQ test plan
Challenge test plan
Records of signatures
Test equipment/Instrument list
Test data sheets
SOP’s
References
Conclusions
Attachments
31
32. Process Validation
The documented verification providing a high
degree of assurance that a specific process will
consistently produce a product meeting its
predetermined specifications and quality
attributes.
The new guidelines aligns process validation
activities with a product life cycle concept.
32
34. Life Cycle of the product & the process
Stage 1 – Process Design
Stage 2 – Process qualification
Stage 3 - Continuous process verification
34
35. It is the activity of defining the commercial manufacturing
process that will be reflected in planned master production
and control records.
The goal of this stage is to design a process suitable for
routine commercial manufacturing that can consistently
deliver a product that meets its quality attributes.
It is based on the knowledge gained through development &
scale-up activities.
35
36. During this stage, the process design is evaluated to
determine if the process is capable of reproducible
commercial manufacturing. The products
manufactured during this stage, if acceptable , can be
released for distribution.
Two Aspects
Design of facility and qualification of equipment and
utilities.
Process Performance Qualification ( PPQ).
36
37. Def.: “Releasing for distribution a lot of finished
product, manufactured following a qualification
protocol, that meets the standards established in
the protocol, but before the entire study has been
executed”.
Orphan Drugs
Specific drug for specific use
Short Shelf-life radio pharmaceuticals
37
38. The goal of this stage is continual assurance that the
process remains in a state of control ( the validated state)
during commercial manufacture.
The cGMP requirements, specifically the collection &
evaluation of information & data about the performance
of the process will allow detection of undesired process
variability.
This stage is also applicable for legacy products.
38
39. Change Control
Formal evaluation of the potential impact of
planned modifications on the validated status
of a product, process or facility.
39
40. Training personnel for IQ/OQ execution.
The purpose of the equipment/ system.
Use of test equipment
Applicable SOP’s
cGMP documentation of training
Document all training
Periodically review training requirements
40
41. A document that summarizes and analyses
the test results at the end of PQ.
Provides a conclusion about the ability of the
system to consistently meet acceptance
criteria.
May be a stand alone document at each
stage of IQ/OQ and PQ to summarize results.
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42. Commissioning and Qualification
Project Phases Validation Phases
Technology Transfer Collecting data
Conceptual Design
Basic Design Preliminary VMP
Detailed Design Detailed VMP
Procurement Detailed planning,DQ
Construction IQ
Pre commissioning
Commissioning OQ
Process operation / Validation
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43. 43
Introduction Qualification Personnel Schedule
Preventive
Maintenance
Installation
Operation
Process
Responsibilities
Training
Change
Control
Procedures
Documents
Appendices
44. The company’s overall policy, intentions and
approach to validation, including :
Validation of production processes
Cleaning procedures
Analytical methods
In-process control test procedures
Computerized systems
Persons responsible for design, review, approval
Documentation of each validation phase
44
45. Product validation is NOT ……
- just 3 batches that meet specifications
Product validation is ……
- an ongoing process to build confidence into
the manufacturing activities
- an ability to demonstrate consistency at any
time.
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46. Cleaning validation is establishing
documented evidence that the equipment
is consistently cleaned from product,
microbial and cleaning agent residues to
predetermined acceptable levels.
46
47. A written procedure for cleaning validation
which includes :
Responsibility for development, performance and
approval of the validation study.
Establishment of SOP’s
Acceptance criteria
- defined to prevent cross contamination
- definition of residue limits
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48. Cleaning procedure for each piece of equipment
- Flow charts and diagrams
- Cleaning agents, concentration, volume
- Frequency
- time left ‘dirty’
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50. Validation report
- Results Vs. acceptance criteria
- Deviations and how handled
- Conclusion that cleaning process is
validated
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51. Major change in cleaning procedure
Change in cleaning agent
New equipment
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52. Knowledge of the materials
- Potency of the drug
- Pharmacological and toxic properties
- Degradation products
- Cleaning agents
- Micro residues
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53. Residual Limits must be………….
Practical
Achievable
Verifiable
Safe
FDA does not set acceptance specifications
(limits).
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54. MAC = TD x BS x SF / LDD
MAC = Maximum Allowable Carryover
TD = Single Therapeutic Dose
BS = Batch size of next product to be
manufactured on the same equipment.
SF = Safety Factor
LDD = Largest Daily Dose of the next product
in the same equipment.
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55. Ranitidine Tablets - Ibuprofen Tablets
TD = Single Therapeutic Dose = 150 mg Ranitidine-Tab
BS = Batch Size = 100 kg of Ibuprofen
SF = Safety Factor = 1/1000
LDD = Largest Daily Dose of the next product in the same
equipment = 200 mg X 5 tablets of Ibuprofen
MAC = Max Allowable Carryover = 150 X 100 X 1000 x
1000 X 1/1000 X 1/1000
i.e 15000 mg in 100 kg Batch size
i.e 150 mg in 1 kg = 150 ppm
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