Validation Protocol & Report Format + Types PDF PPT (2023)

Process validation principle incorporates the understanding that the following conditions exist:

• Quality, safety, and efficacy are designed or built into the product.
• Quality cannot be adequately assured merely by in-process and finished-product
inspection or testing.

Here are the details of Validation Protocol & Report Format + Types PDF PPT . Analytical validation seeks to demonstrate that the analytical methods yield results which permit an objective evaluation of the quality of the pharmaceutical product as specified. The person responsible for the quality control laboratory should ensure that test methods are validated. The analytical devices used for these tests should be qualified and the measuring instruments used for the qualification should be calibrated. Each new test procedure should be validated.

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the lifecycle of the product and process. This guidance describes process validation activities in three stages.
• Stage 1 – Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
• Stage 2 – Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
• Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

A suggested scheme for Validation protocol and report concerning any particular process in pharmaceutics is here:

Steps for writing Validation protocol and report:

Part 1. Purpose (the validation) and prerequisites
Part 2. Presentation of the entire process and subprocesses, flow diagram, critical steps/risks
Part 3. Validation protocol, approval
Part 4. Installation qualification, drawings
Part 5. Qualification protocol/report

5.1 Subprocess 1

5.1.1 Purpose

5.1.2 Methods/procedures

list of manufacturing methods, SOPs, and written procedures, as applicable

5.1.3 Sampling and testing procedures

Acceptance criteria (detailed description of, or reference to, established procedures, as described in pharmacopoeias)

(Video) VALIDATION OF ANALYTICAL METHOD | Method validation | Validation of an analytical procedure

5.1.4 Reporting Calibration

Calibration of test equipment used in the production process Test data (raw data) Results (summary)
5.1.5 Approval and requalification procedure
5.2 Subprocess 2 (same as for Subprocess 1)

5.n Subprocess

Part 6. Product characteristics, test data from validation batches

Part 7. Evaluation

Evaluation including comparison with the acceptance criteria and recommendations (including frequency of revalidation/requalification)

Part 8. Certification (approval)

Part 9.Abbreviated version of the validation report

If applicable, preparation of an abbreviated version of the validation report for external use, for example by the regulatory authority

The validation protocol and report may also include copies of the product stability report or a summary of it, validation documentation on cleaning, and analytical methods.

Depending on when it is performed in relation to production, validation can be prospective, concurrent, retrospective or revalidation (repeated validation).

  1. prospective
  2. concurrent
  3. retrospective
  4. revalidation

Type 1 – Prospective validation

Prospective validation is carried out during the development stage by means of a risk analysis of the production process, which is broken down into individual steps: these are then evaluated on the basis of past experience to determine whether they might lead to critical situations.

Where possible critical situations are identified, the risk is evaluated, the potential causes are investigated and assessed for probability and extent, the trial plans are drawn up, and the priorities set. The trials are then performed and evaluated, and an overall assessment is made. If, at the end, the results are acceptable, the process is satisfactory. Unsatisfactory processes must be modified and improved until a validation exercise proves them to be satisfactory. This form of validation is essential in order to limit the risk of errors occurring on the production scale, e.g. in the preparation of injectable products.

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Type 2-Concurrent validation

Concurrent validation is carried out during normal production. This method is effective only if the development stage has resulted in a proper understanding of the fundamentals of the process. The first three production-scale batches must be monitored as comprehensively as possible.1The nature and specifications of subsequent in-process and final tests are based on the evaluation of the results of such monitoring.

1 This careful monitoring of the first three production batches is sometimes regarded as prospective validation.
Concurrent validation together with a trend analysis including stability should be carried out to an appropriate extent throughout the life of the product.

Process validation template Types format PDF

Type 3-Retrospective validation

Retrospective validation involves the examination of past experience of production on the assumption that composition, procedures, and equipment remain unchanged; such experience and the results of in-process and final control tests are then evaluated. Recorded difficulties and failures in production are analysed to determine the limits of process parameters. A trend analysis may be conducted to determine the extent to which the process parameters are within the permissible range.

Retrospective validation is obviously not a quality assurance measure in itself, and should never be applied to new processes or products. It may be considered in special circumstances only, e.g. when validation requirements are first introduced in a company. Retrospective validation may then be useful in establishing the priorities for the validation programme. If the results of a retrospective validation are positive, this indicates that the process is not in need of immediate attention and may be validated in accordance with the normal schedule. For tablets which have been compressed under individual pressure-sensitive cells, and with qualified equipment, retrospective validation is the most comprehensive test of the overall manufacturing process of this dosage form. On the other hand, it should not be applied in the manufacture of sterile products.

Type 4-Revalidation

Revalidation is needed to ensure that changes in the process and/or in the process environment, whether intentional or unintentional, do not adversely affect process characteristics and product quality.

Revalidation may be divided into two broad categories:

• Revalidation after any change having a bearing on product quality.
• Periodic revalidation carried out at scheduled intervals.
Revalidation after changes. Revalidation must be performed on introduction of any changes affecting a manufacturing and/or standard procedure having a bearing on the established product performance characteristics. Such changes may include those in starting material, packaging material, manufacturing processes, equipment, in-process controls, manufacturing areas, or support systems (water, steam, etc.). Every such change requested should be reviewed by a qualified validation group, which will decide whether it is significant enough to justify revalidation and, if so, its extent.

(Video) Process Validation in Pharmaceutical Manufacturing

Re-validation after changes may be based on the performance of the same tests and activities as those used during the original validation, including tests on sub-processes and on the equipment concerned. Some typical changes which require revalidation include the following:

• Changes in the starting material(s). Changes in the physical properties, such as density, viscosity, particle size distribution, and crystal type and modification, of the active ingredients or excipients may affect the mechanical properties of the material; as a consequence, they may adversely affect the process or the product.

• Changes in the packaging material, e.g. replacing plastics by glass, may require changes in the packaging procedure and therefore affect product stability.

• Changes in the process, e.g. changes in mixing time, drying temperature and cooling regime, may affect subsequent process steps and product quality.

Process validation template Types format PPT Power Point

• Changes in equipment, including measuring instruments, may affect both the process and the product; repair and maintenance work, such as the replacement of major equipment components, may affect the process.

• Changes in the production area and support system, e.g. the rearrangement of manufacturing areas and/or support systems, may result in changes in the process. The repair and maintenance of support systems, such as ventilation, may change the environmental conditions and, as a consequence, revalidation/requalification may be necessary, mainly in the manufacture of sterile products.

• Unexpected changes and deviations may be observed during self-inspection or audit, or during the continuous trend analysis of process data.
Periodic revalidation. It is well known that process changes may occur gradually even if experienced operators work correctly according to established methods. Similarly, equipment wear may also cause gradual changes. Consequently, revalidation at scheduled times is advisable even if no changes have been deliberately made.

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The decision to introduce periodic revalidation should be based essentially on a review of historical data, i.e. data generated during in-process and finished product testing after the latest validation, aimed at verifying that the process is under control. During the review of such historical data, any trend in the data collected should be evaluated.

In some processes, such as sterilization, additional process testing is required to complement the historical data. The degree of testing required will be apparent from the original validation.

Read more about Process Validation

Additionally, the following points should be checked at the time of a scheduled revalidation:

• Have any changes in master formula and methods, batch size, etc., occurred? If so, has their impact on the product been assessed?

• Have calibrations been made in accordance with the established programme and time schedule?

• Has preventive maintenance been performed in accordance with the programme and time schedule?

• Have the standard operating procedures (SOPs) been properly updated?

(Video) 3 stages and 4 types of Process Validation | FDA Guidance on process validation

• Have the SOPs been implemented?

• Have the cleaning and hygiene programmes been carried out?

• Have any changes been made in the analytical control methods?


What is validation protocol and validation report? ›

Validation Protocol is defined as a written plan describing the process to be validated, including production equipment and how validation will be conducted. A Validation Protocol is necessary to define the specific items and activities that will constitute a cleaning validation study.

What is validation and its types? ›

The guidelines on general principles of process validation mentions four types of validation: A) Prospective validation (or premarket validation) B) Retrospective validation. C) Concurrent validation. D) Revalidation.

How many types of validation are there in pharma? ›

Based on this description, there are 4 types of process validation: prospective validation, retrospective validation, concurrent validation, and revalidation.

What are the 5 major phases in validation process? ›

  • Stage 1 – Process Design.
  • Stage 2 – Qualification. Part 1 – Facility Design. Part 2 – Qualification of Utilities & Equipment. Subsection 1 – Installation Qualification. Subsection 2 – Operational Qualification. Subsection 3 – Performance Qualification. ...
  • Stage 3 – Continued Process Verification.

What is report validation? ›

Validation Report means a document in which the records, results and evaluation of a completed validation program and proposals for the improvement of processes or equipment are assembled.

What are the 3 stages of process validation? ›

The Three Stages of Process Validation are: Stage 1 – Process Design. Stage 2 – Process Validation or Process Qualification. Stage 3 – Continued Process Validation.

What are the 3 types of data validation? ›

Different kinds
  • Data type validation;
  • Range and constraint validation;
  • Code and cross-reference validation;
  • Structured validation; and.
  • Consistency validation.

What is validation method? ›

Method validation is a demonstration of the method suitability by determining an accuracy of the test results as well as an uncertainty and a traceability of measurements. Method validation is needed for proving whether new method is fit for purpose or specified samples.

What is GMP validation? ›

GMP validation is the act of documenting objective evidence that offers a high level of assurance that a specific cleanroom process will consistently deliver products that meet predetermined specifications. It follows these four steps: Performance/Process Validation, which is step #4 of the qualification process above.

What are the types of validation testing? ›

Common types of database validation testing include:
  • Data mapping.
  • ACID validation.
  • Data integrity checks.
  • Business rule compliance tests.
  • Data accuracy tests.
  • Data completeness tests.
  • Data transformation tests.
  • Data quality tests.
9 Nov 2020

What is IQ OQ PQ validation protocol? ›

IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.

What is the validation life cycle? ›

The Validation Life Cycle is an implementation mechanism which can assist pharmaceutical (and other types of medical product) manufacturers in the organization and execution of validation activities. A considerable body of work exists which identifies how to validate processes of various type and description.

What is an example of validation? ›

To validate is to confirm, legalize, or prove the accuracy of something. Research showing that smoking is dangerous is an example of something that validates claims that smoking is dangerous.

What is the purpose of validation report? ›

The Validation Report includes general purpose (not error specific) messages to inform data providers of specific circumstances of the validation flow instance.

What are the two key elements of validation? ›

The Validation phase consists of two key elements: Conducting data analysis of collected data to identify conclusions, insights, and trends. Reporting analyses, observations, and potential COAs.

What is the purpose of validation process? ›

The purpose of process validation is ultimately to demonstrate with a high degree of assurance that the process can produce products that can be consistently manufactured while meeting predetermined specifications within stated parameters.

Why are there only 3 batches for validation? ›

When two batches are taken as validation the data will not be sufficient for evaluation and to prove reproducibility because statistical evaluation cannot be done on two points, it needs minimum three points because two points always draw a straight line.

What are the 8 types of data validation rules? ›

Types of Data Validation
  • Data Type Check.
  • Code Check.
  • Range Check.
  • Format Check.
  • Consistency Check.
  • Uniqueness Check.
  • Presence Check.
  • Length Check.
7 Apr 2022

What are validation tools? ›

The TSDS Validation Tool is a an application that users download to their local systems (#1 in the diagram below). The tool allows user to convert data from spreadsheet format to XML (for limited data sets). It also allows users to validate their XML files before loading to TSDS.

What are the 4 step processes of data validation? ›

The data Validation process consists of four significant steps.
  • Detail Plan. It is the most critical step, to create the proper roadmap for it. ...
  • Validate the Database. This is responsible for ensuring that all the applicable data is present from source to sink. ...
  • Validate Data Formatting. ...
  • Sampling.
29 Sept 2022

WHO guideline process validation? ›

process validation.

The collection and evaluation of data, throughout the product life-cycle, which provides documented scientific evidence that a process is capable of consistently delivering quality products.

What is quality validation? ›

"Validation—Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (6)."

What is full validation? ›

Full validation including all accuracy, precision and bench top stability, freeze thaw stability, and where appropriate extract stability is required.

What are the validation parameters? ›

Validation parameter is used for establishing documented evidence which proves that performance characteristics of the method meet the requirements for the intended analytical applications.

What are the steps of method validation? ›

2.1. Parameters to be checked for method validation
  1. Selectivity/Specificity.
  2. Precision.
  3. Accuracy.
  4. Linearity.
  5. Range.
  6. Stability.
  7. Limit of Detection (LOD) and Limit of Quantitation (LOQ)

What is CSV in pharma? ›

Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and ...

What is API validation? ›

API validation is the process of checking to see if an API meets certain requirements for how it works, how well it performs, how safe it is, and other things. It is an important part of developing software because it helps make sure that an API meets the needs of its users and works as expected.

What is QA validation in pharma? ›

Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.

What is the first step in report validation? ›

Depending on the risk and complexity of the software, different levels of validation rigor should be performed.
  1. Step 1: Create the Validation Plan. ...
  2. Step 2: Define System Requirements. ...
  3. Step 3: Create the Validation Protocol & Test Specifications. ...
  4. Step 4: Testing. ...
  5. Step 5: Develop/Revise Procedures & Final Report.
2 May 2020

What is a validation test? ›

Validation testing is the Quality Assurance (QA) process of verifying that a software application meets the needs and requirements of its stakeholders. The main goal of validation testing is to verify whether a software product meets its acceptance criteria.

What is validation testing example? ›

Validation tests must be run after every feature or step in the development process is completed. For example, unit tests, a form of validation tests, are run after every unit of code has been created. Integration tests are run after multiple modules have been completed individually and are ready to be combined.

Is a type of validation? ›

Prospective Validation. Concurrent Validation. Retrospective Validation. Revalidation (Periodic and After Change)

What is type check? ›

Type checking is the process of verifying and enforcing constraints of types in values. A compiler must check that the source program should follow the syntactic and semantic conventions of the source language and it should also check the type rules of the language.

What is a validation table? ›

The _Validation table is a system table that contains the column names and the column values for all of the tables in the database. It is used during the database validation process to ensure that all columns are accounted for and have the correct values.

What is IQ in validation? ›

IQ stands for Installation Qualification. This is the first step in the validation process to ensure that the manufacturing process will live up to its expectations. In this phase you verify the equipment's design features and make sure it was installed correctly.

What is difference between OQ and PQ? ›

Operational Qualification (OQ) checks and documents that each individual function of the item performs as expected. For example, does it runs at the required speed or heats up a liquid to the required temperature. Performance Qualification (PQ) checks and documents that the equipment and systems meet the users' needs.

What comes first OQ or PQ? ›

Operational Qualification (OQ) involves identifying and inspecting equipment features that can impact final product quality. Performance Qualification (PQ) is the final step of qualifying equipment.

How do you maintain a computer system in a validated state? ›

  1. Develop Clear and Precise Functional and User Requirements. ...
  2. Perform risk-based CSV. ...
  3. Create a Good Validation Plan. ...
  4. Create a Good Team. ...
  5. Avoid Ambiguous Test Scripts. ...
  6. Create Good Documentation. ...
  7. Audit third-party Providers.
17 Jun 2018

What are validation rules? ›

A validation rule is one way to restrict input in a table field or a control (such as a text box) on a form. Validation text lets you provide a message to help users who input data that is not valid.

What do we mean by validation? ›

/ˌvæl.əˈdeɪ.ʃən/ [ U ] the act or process of making something officially or legally acceptable or approved: Parking is free with validation of your ticket by one of the outlets in the mall.

How do you use validation? ›

The court validated the contract. A judge still needs to validate the election. Customs officers validated our passports. The decline in sales only validated our concerns.

What is the purpose of a validation report? ›

The purpose of a Validation Summary Report (VSR) is to provide a concise overview of the entire validation effort and the results obtained. Additionally, the approval of the VSR authorizes the release of the system for operational use.

What is validation report in pharmaceutical industry? ›

The validation process is the documented evidence which provides a high degree of assurance to a desired result with predermined compliance. The term validation is widely used in pharmaceutical industries. This term comes from the word “valid or validity” which means “legally defined”.

What should be in a validation report? ›

The validation summary report should include: A description of the validation project, including the project scope. All test cases performed, including whether those test cases passed without issue. All deviations reported, including how those deviations were resolved.

What is validation based protocol? ›

Validation Based Protocol is also called Optimistic Concurrency Control Technique. This protocol is used in DBMS (Database Management System) for avoiding concurrency in transactions.

What is validation summary? ›

The ValidationSummary class is used to summarize the error messages from all validators on a Web page in a single location. You can summarize the error messages from a group of validators on a Web page by assigning the ValidationSummary control to a validation group by setting the ValidationGroup property.

What is GMP validation? ›

GMP validation is the act of documenting objective evidence that offers a high level of assurance that a specific cleanroom process will consistently deliver products that meet predetermined specifications. It follows these four steps: Performance/Process Validation, which is step #4 of the qualification process above.

Why do you need 3 batches for validation? ›

Generally, it is considered if we get the desired quality in the first batch, it is accidental, second batch quality is regulator and quality in the third batch is Validation.

What is validation method? ›

Method validation is a demonstration of the method suitability by determining an accuracy of the test results as well as an uncertainty and a traceability of measurements. Method validation is needed for proving whether new method is fit for purpose or specified samples.

What is software validation report? ›

Software validation is the process of establishing documented evidence that confirms a computer system has been installed correctly, will meet users' needs and functions according to its intended use.

What is a product validation report? ›

Product ExperienceFeedback AnalysisSurveys & Feedback Collection. Product validation is the process of determining whether a product concept or idea has the potential to meet the needs of customers, consumers, and stakeholders.

How do you write a validation plan? ›

A Validation Plan should include:
  1. Deliverables (documents) to be generated during the validation process.
  2. Resources, departments, and personnel to participate in the validation project.
  3. Time-lines for completing the validation project.
  4. Acceptance criteria to confirm that the system meets defined requirements.

What is multi version protocol? ›

Multiversion concurrency control (MVCC) is a database optimization technique that creates duplicate copies of records so that data can be safely read and updated at the same time. With MVCC, DBMS reads and writes don't block each other.

Which is optimistic protocol? ›

The protocol is "optimistic" in that transactions are processed without restrictions during the failure; conflicts are detected at repair time using a precedence graph and are resolved by backing out transactions according to some backout strategy.

How many times terms are associated in validation based protocol? ›

There are three timestamps that control the serializability of the validation based protocol in the database management system, such as. Start(Timestamp): The start timestamp is the initial timestamp when the data item being read and executed in the read phase of the validation protocol.


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