pharmaceutical validation pharmaceutical engineering validation

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VALIDATION
Introduction to pharmaceutical validation,
scope & merits of validation

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CONTENTS:
 Introduction
 Definition
 Why validation is required
 Documentation of validation
 Validation master plan
 Scope of validation
 Types of validation
 Advantages
 Disadvantages
 Conclusion

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INTRODUCTION :
 Pharmaceutical validation is the process of establishing
documentary evidence to show that a process, system, or
equipment consistently produces the expected results and
meets predefined quality standards and regulatory
requirements.
 It ensures drug products are safe, effective, and of high
quality, forming a fundamental component of
current Good Manufacturing Practices (cGMP).

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DEFINITION:
validation is the documented process of proving that a specific
process, system, or equipment consistently produces a product
meeting predetermined specifications and quality attributes.

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WHY VALIDATION IS REQUIRED!
The pharmaceutical industry uses expensive material, advanced facilities and equipment and highly qualified personals.
It would not be feasible to use equipment not knowing if it will produce the product we want, not to employ the people with no assurance that they can do or fail to implement process checks or examination to assure that product meet specification.
 Customer satisfaction
 Product liability
 Control production cost
 The development of next generation
 Safety

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DOCUMENTATION OF VALIDATION
The validation activity cannot be completed without proper
documentation of each and every minute activity with utmost
details.
Documentation of validation is generally of different types
such as:
Validation Master Plan(VMP)
Validation Protocol(VP)
Validation Reports(VR)
Standard Operating Procedure(SOP)

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VALIDATION MASTER PLAN
 A Validation Master Plan is a document that summarizes the firm's
overall philosophy, intention and approaches to be used for
establishing performance adequacy.
 A tool to track progress.
 Assignment of responsibility and team work.
 It identifies acceptance criteria before the start of validation.
 V.M.P gives idea about future performance:
 What activities are to be performed?
 Who is going to perform these activities?
 When the activities should start and when they should get over?
 What documents will be generated?
 What the policy on revalidation?

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V.M.P. includes
 Premises
 Processes
 Products
 Format for protocol and other documentation
 List of relevant SOPs
 Planning and scheduling
 Location
 Estimation of staffing requirements
 A time plan of the project

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SCOPE OF VALIDATION:
:
 Selection of raw material i.e. raw materials of desired quality attributes.
 Product design based on the expected performance.
 Process design to build the desired quality attributes in the product.
 Design of control parameters, such as change control, acceptance criteria, tolerance limits, etc.
 In process quality control parameters and sampling plans
 Finished product testing or evaluation criteria.
 Validation of related analytical process, facility and equipment.
 Personnel training.
 Validation involves careful determination of criteria variable of the process, such as moisture content of granules, drying temperature of time, etc.

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URS, FAT and SAT:
User Requirement Specifications- Manufacturers should prepare a document that describes, for example, the utility or equipment to be sourced.
The requirements and specifications for the utility or equipment should be defined by the user and should be documented in the URS.
Factory Acceptance Test and Site Acceptance Test- Where appropriate, FAT and SAT should be performed to verify the suitability of the system
at site, prior to the subsequent stages of qualification. This should be appropriately documented.

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TYPES:

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CLEANING VALIDATION:
• Cleaning validation in the pharmaceutical industry is a
documented process that proves a cleaning procedure
consistently removes residues of previous products, cleaning
agents, and microorganisms to acceptable, safe levels.
• It ensures equipment is free from contaminants, thereby
preventing cross-contamination and protecting patient safety

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Prospective validation should include the following:
1. Short description of the process
2. summary of the critical processing steps to be investigated
3. List of the equipment’s to be used along with their calibration
status
4. Finished product specifications for release
5. List of analytical methods
6. Proposed in-process controls with acceptance criteria
7. Additional testing to be carried out
8.Sampling plan
9.Methods for recording and evaluating results
10.Functions and responsibilities

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B) Concurrent Process Validation:
The concurrent process validation establishes documented
evidence that the process is in a state of control during the actual
execution of the process
It is a process where current production batches are used to
monitor processing parameters.
It gives of the present batch being studied, and offers limited
assurance regarding consistency of quality from batch to batch.
This time the in-process quality control parameter are also decided
and monitored.

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C) Retrospective Process validation:
It is defined as established documented evidence that a system
does what it supports to do on the review and analysis of historical
information. This is achieved through the review of the historical
manufacturing testing data to prove that the process has always
remained in control
It is conducted for a product already being marketed, and is based
on extensive data accumulated over several lots and over time.
Retrospective Validation is only acceptable for well established
detailed processes and will be Inappropriate where there have
recent changes in the formulation of the products, operating
procedures, equipment and facility.

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The retrospective process validation should contain the following:
• Batches manufactured for a defined period (minimum of
10 last consecutive batches)
• Number of lots released per year
• Batch size/strength/manufacturer/year/period
• Master manufacturing/packaging documents
• Current specifications for active materials/finished
products
• List of process deviations, corrective actions and changes
to manufacturing documents

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D) Revalidation:
Required when there is a change in any of the critical process parameters,
formulation, primary packaging components, raw material fabricator, major
equipment or premises.
Failure to meet product and process specifications in batches would also require
process re- validation.
Revalidation becomes necessary in certain situations.
 Changes in raw materials
 Changes in the source of active raw material manufacturer. • Changes in
packaging material
 Changes in the process

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Types of Equipment Validation:

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A) Design Qualification:
It is a documented verification that the proposed design is
suitable for intended purpose.” The design qualification outline
the key features of the system designed to address the user
requirements, regulatory compliance and selection rationale of a
particular supplier.
Important DQ consideration include:
1.GMP s and regulatory requirements.
‟
2.Performance criteria.
3. Facility air flow, movement flow and pressure regimens.

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B) Installation Qualification:
It is a documented verification that all the aspects of a facility,
utility or equipment that can affect product quality adhere to
approved specifications and are correctly installed.
Important IQ consideration include:
1.Installation conditions (wiring, utilities, and functionality)
2. Calibration, Preventive maintenance, cleaning schedules.
3. Safety features.
4. Supplier documentation, prints, drawings and manuals.
5. Software documentation
6. Spare parts list.

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C) Operational Qualification:
It is a documented verification that all aspects of a facility, utility or
equipment that can affect product quality
OQ considerations include:
 Process control limits (time, temperature, pressure, line speed, and setup
conditions).
 Raw material specification.
 Process operating procedures
 Material handling requirements.
 Process change control
 Training
 Short term stability and capability of the process

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D) Performance Qualification:
It is a documented verification that all aspects of a facility, utility
or equipment perform as intended in meeting predetermined
acceptance criteria.
PQ consideration include:
1.Actual product and process parameters and procedures
established in OQ.
2. Acceptability of the product.
3. Assurance of process capability as established in OQ.
4. Process repeatability, long term process stability

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Advantages of validation:
1.Consistent through output.
2. Reduction in rejections and reworks.
3. Reduction in utility cost.
4. Avoidance of capital expenditures.
5. Fewer complaints about process related failure.
6. Reduced testing process and finished goods.

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Disadvantages of validation:
1.Validation is time consuming process.
2. The process for manufacture is often complex and
costly.
3. Validation also has practical limit and related cost.

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• Reduction of quality cost
• Process Optimization
• Assurance of quality
• Safety
• Better consumer quality
Application of validation

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CONCLUSION:
This review gives an idea about the validation in pharmaceutical industry.
Validation is an essential component of GMP. Validation helps assure product
will meet standard quality, safety, efficacy, purity, effectiveness according to
GMP.
Validation is commonly used in drug development, manufacturing and
specification of final product.
Validation is helps in eliminating the chances of batch failure as the product
are manufactured under optimizing each manufacturing stage.
Validation helps in reduce the cost of quality which gives the best quality of
product.

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REFERENCES:
1. Anju G, Pandey P. Process Validation of Pharmaceutical Dosages Form: A Review.
Biomedical Journal of Scientific and Technical Research. 2017;1(5):1467–75.
2. 2. Ahir KB, Singh KD, Yadav SP, Patel HS, Poyahari CB. Overview of Validation and
Basic Concepts of Process Validation. Scholars Academic Journal of Pharmacy
(SAJP). 2014;3(2):178–90.
3. 3. Harpreet K, Gurpreet S, Nimrata S. Pharmaceutical Process validation: A Review.
Journal of Drug Delivery and Therapeutics. 2013;3(4):189–94.
4. .Jain K, Agrawal P, Bharkatiya M. A Review on Pharmaceutical Validation and Its
Implication. International Journal of Pharmacy and Biological Sciences.
2018;8(2):117–26.
5. Sharma M, Agarwal S, Agarwal S, Sharma M. Prospective Validation: A Review. The
Pharma Innovation. 2015;4(3):1–7.
6. Mead, W. J., Process validation in cosmetic manufacture, Drug Cosmet. Ind., (Sep
tember 1981).
7. Chapman, K. G., A history of validation in the United States, Part I, Pharm. Tech.,
(November 1991).
8. Nash, R. A., The essentials of pharmaceutical validation in Pharmaceutical Dosage
Forms: Tablets, Vol. 3, 2nd ed., Lieberman, H. A., Lachman, L. and Schwartz, J. B.,
eds., Marcel Dekker, New York (1990).

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