validation is an important documentation protocol used in most of the laboratories and industries which is used for validation and evaluating different research protocols and equipment used in product formulation and development

1. Under the guidance of Asst. Prof. Mrs. Komala
Presented By
Rakesh. G (18P6422)
B.Pharm, 4th Year, 7th Semester
KR College of Pharmacy, Bangalore

2. Contents
Introduction and History
Departments responsible for validation, advantages and scope of
validation.
Validation and its types.
Validation documentation
Validation Master Plan
Validation protocol
Validation report
Conclusion
References

3. VALIDATION
Definition:
Validation is a part of quality assurance which provides documented
evidence for any procedure, process, design, material, activity or system
which leads to yield the desired quality of results as approved.
As per FDA USFDA:
Validation is establishing documented evidence which provides a high
degree of assurance that a specific process, system, equipment or
assay will consistently produce the desired results accordingly to
predetermined specifications and quality attributes.

4. History of Validation
The concept of validation was first proposed by two FDA
officials, Ted Byers and Bud Loftus, in order to improve the
quality of pharmaceuticals.
In 1976 the FDA proposed a whole set of current GMP
(cGMP) regulations which were revised several times. In
several major countries GMP regulations are considered
official law and noncompliance in prosecutable.
USFDA was the pioneer in advocating the concept of process
validation, but till 29th September 1978 there was no definition
and no cGMP regulations talked anything about validation.

5. Departments responsible for Validation
 Site Validation Committee: Develop site Master Validation Plan (MVP).
 Manufacturing Department: Prepares the batches as though their routine
production batches and assist the collection of data.
 Quality Assurance: Approves protocols and reports. Checking the
compliance of documentation and procedures. Review of validation
documents.
 Quality Control: Perform testing contracts, validation testing, review
protocols and reports.
 R&D: Deals with product design.
 Engineering Department: Installation, quality and certify plant, facilities,
equipment and support systems

6. Advantages of Validation
 Process parameters and controls are determined during the validation of any process or system.
 It helps to determine the worst case and risks that may arise during the manufacturing of the quality
products.
 Validation helps to investigate the deviations caused during the process.
 Deep study and understanding of the system and equipment are made possible due to validation.
 The risk of regulatory non-compliance is minimized after the validation. A validated process
required less process control and the finished product testing.
 Batch to batch variation is minimized due to the validation of process, systems and equipment.
 Reduces the production cost of product
 Increases the production of manufacturing facility due to the minimized rework and rejection.
 A validated process required less process control and finished product testing.
 Decreases the chances of the failure of the batches.

7. Scope of Validation
 Appropriate and sufficient system of organizational and documentation
infrastructure, sufficient personnel and financial resources to perform validation
tasks in timely manner.
 Personnel with appropriate qualifications and experience should be responsible for
performing validation. They should represent different departments depending on
the validation work to be performed.
 There should be proper preparation and planning before validation performed.
 Validation should be performed:
 For new premises, equipment, utilities and systems, processes and procedures.
 At periodic intervals; and
 When major changes have been made.
 Validation should be performed in accordance with written protocols. A written report
on the outcome of the validation should be produced.

8.  Validation practically covers every aspect of pharmaceutical processing activities,
hence defining the Scope of Validation becomes a really difficult task. However, a
systematic look at the pharmaceutical operations will point out at least the following
areas for pharmaceutical validation.
 Packaging materials
 Analytical
 Instrument Calibration
 Process Utility services
 Raw materials
 Equipment
 Facilities
 Manufacturing operations
 Product Design
 Cleaning

9. Validation and its types
Types of
Validation
Process
Validation
Cleaning
Validation
Equipment
Validation
Validation of
Analytical
methods

10. Validation
Process
Validation
Prospective
Validation
Concurrent
Validation
Retrospective
Validation
Revalidation
Cleaning
Validation
Equipment
Validation
Design
Qualification
Installation
Qualification
Operational
Qualification
Performance
Qualification
Process
Qualification
Analytical
Method of
Validation

11. 1. Process Validation: It is defined as the collection and
evaluation of data, from the process of design stage
throughout production, which established scientific
evidence that a process is capable of consistently
delivering quality products.
2. Cleaning Validation: Cleaning validation provides
documented set up with a high degree of surety that
particular system/equipment or part of ids consistently
clean up to predetermined quality and acceptable limits.

12. 3. Equipment Validation: Equipment validation is established
documented set up that proves any equipment works correctly and
leads to accepted and accurate results (predetermined results).
The process of equipment validation is based on the principle that
equipment must be designed, constructed, maintained and adapted
to perform operations which are to be carried out.
4. Analytical Method of Validation: The purpose of analytical
validation is to verify that the selected analytical procedure will give
reliable results that are adequate for the intended purpose. There
are different parameters which come under this method are;
Accuracy, Precision, Reproducibility, Specification, Range,
Detection limit etc.

13. Validation Master Plan
Validation Master Plan is an internally approved document that describes I clear and
concise working about the general expectations, intensions, methods and approach to be
used during the entire validation process. VMP should be a summary document and
should be brief, concise and clear.
Format and Content:
 Introduction: Validation policy, scope, location and schedule.
 Organizational structure: personnel responsibilities
 Plant/process/product description.
 Specific process considerations that are critical and require extra attention.
 List of products/processes/system to be validated, summarized.
 Re-validation activities, actual status.
 Key acceptance criteria
 Documentation criteria and reference of the SOP’s.
 Time plans of each validation project and subproject.

14. Validation Protocol
It is defined as a written plan describing the process to be validated, including
production equipment and how validation will be conducted. Objectives, scope of
coverage of the validation study.
Outline of Validation Protocol:
 Objective and scope
 Process description
 Identification of critical parameters
 Description of analytical method
 Documentation
 Conclusion and Approval
 Final Report

15. Validation Report
A written report should be available after completion of the validation. If found
acceptable, it should be approved and authorized. If found acceptable, it should
be approved and authorized.
The report should include at least the following:
 Title and objective of study
 Reference to protocol
 Details of material Equipment
 Programmes and cycles used
 Details of procedures and test methods
 Results
 Recommendations on the limit and criteria to be applied on future basis

16. Conclusion
Pharmaceutical validation which incorporates assay
validation, cleaning validation, equipment validation
and additionally the general procedure of approval is
vital in strength examination, clinical improvement, like
example, bioavailability, bioequivalence.

17. References
 Jindal D, Kaur H, Patil RK, Patil HC. Validation – In pharmaceutical industry:
Equipment validation: A brief review. Adesh Univ J Med Sci Res 2020;2(2):94-8.
 Saroj Kumar Raul, Gopal Krishna Padhy, Anjan Kumar Mahapatra, Soudamini
Alekha Charan. An Overview of Concept of Pharmaceutical Validation. Research
J. Pharm. and Tech. 7(9): Sept. 2014 Page 1081-1090.
 Sharma PP. Validation in Pharmaceutical Industry (6th ed). United Kingdom:
Informa Healthcare Publication; 2016. p. 51-70.
 Haider SI. Pharmaceutical Master Validation Plan, The Ulimate Guide to FDA,
GMP and GLP Complience, Indian Special Edition, Informa Healthcare, p311

18. Thank You