Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.

1. QUALITY SQUARE INDUSTRY
Process Validation
Mr. Hardik Mistry
Quality Square Industry

2. Hester
Biosciences
Ltd
Business
Profit
Prestige
GMP
QUALITY SYSTEM
- VALIDATION
Customer
satisfaction
Customer
2

3.  Introduction
 Objectives
 Benefits
 Types of Validation
 Phases of Validation
 Process Validation
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4. Validation
 “Validation is establishing documented evidence which provides a
high degree of assurance that a specific process or equipment will
consistently produce a product or result meeting its pre-determined
specification and quality attributes .”
 Validation is a key process for effective Quality Assurance.
 QA is the heart and soul of Quality control
QA = QC + GMP
 Quality Control is incomplete without coordination of Production.
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5.  An exercise to create as much paper as possible
 Another unnecessarily burdensome regulatory requirement
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6.  Confirmation by examination and provision of objective
evidence that the specified requirements have been
fulfilled.
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7.  To form basis for written procedures for production and process
control which are designed to assure that the drug products have
the identity, strength, quality, and purity they purport or are
represented to possess.
 To determine that process consistently performs as intended by
repeatedly running the system on its intended schedules and
reporting all relevant information and data.
Results must demonstrate that the process meets pre-determined
specifications under normal conditions.
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8.  Quality :
- Customer satisfaction : Non-conforming product can lead to lost
customers.
- Customer mandated: Provision for securing good business
 Product liability: Conformance to product specifications must be
maintained.
 Understanding Equipment, System, Processes :
- Process improvement, technology transfer, related product
validation, rapid failure investigations, increased employee
awareness
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9.  Cost reduction :
- Increased efficiency, shortening lead-time resulting in lower
inventories.
- Fewer rejects and reworks
- Longer equipment life by operating the equipment as per
manufacturer’s specification and establishment of cost effective
preventive maintenance schedules.
- Possible reduced testing of raw materials, bulk formulations and
finished products.
 Regulatory requirement
o Successful inspections
o Approved products
o For export
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12. Prospective Validation
 This if performed for all new equipment, products and processes.
 It is a proactive approach of documenting the design, specifications
and performances before the system is operational.
 This is the most defendable type of validation.
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13. Concurrent Validation
 This if performed in two instances i.e. for existing equipment,
verification of proper installation along with specific operational test
is done.
 In case of existing, infrequently made product, data is gathered
from at least three successful trials.
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14. Retrospective Validation
 This is established documented evidence that the process has
performed satisfactorily and consistently over time, based on review
and analysis of historical data.
 The source of such data is production and QA/QC records.
Retrospective validation generally not accepted Because…..
 The issues to be addressed here are changes to equipment, process,
specification and other relevant changes in the past.
 Lack of validation protocols usually indicates a lack of
documentation, and often data is reported as only pass or fail which
does not permit statistical analysis which can only be performed on
numeric data.
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15. Revalidation
 Consider periodic revalidation where cumulative minor changes to
process and raw materials may eventually affect process.
 Sterilization processes typically are revalidated periodically (once a
year or as needed).
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16. Some reasons for revalidation
 Change in process that may affect quality or validation status
 Negative trend in quality indicators
 Change in the product design that affects the process
 Process is moved within facility or transferred from one facility to
another
 Change in the application of the process
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17.  Design Qualification (DQ)
Documented verification of the design of equipment and manufacturing
facilities.
 Installation Qualification (IQ)
Documented verification that equipment is installed and operating
properly.
 Operational Qualification (OQ)
Documented verification of equipment or system performance in the target
operating range.
 Process Performance Qualification (PQ)
Documented verification that equipment or systems operate as expected
under routine production conditions. The operation is reproducible, reliable
and in a state of control.
 Process / Product Validation
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18.  Document stating how validation will be conducted, including test parameters,
product characteristics, manufacturing equipment, and decision points on what
constitutes acceptable test results.
o General information
o Objective
o Background/ Pre validation Activities
Summary of development and technology transfer (from R&D or another site)
activities to justify in-process testing and controls; any previous
validations.
o List of equipment and their qualification status
o Facilities qualification
o Process flow chart
o Manufacturing procedure narrative
o List of critical processing parameters and critical excipients
o Sampling, tests and specifications
o Acceptance criteria
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19. Quality Square Industry 19

20.  Dr. U. K. Jani
 Mr. Kaushal Parekh
Quality Square Industry
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