This document discusses process validation for liquid oral dosage forms. It defines process validation and explains that it ensures consistent production of products meeting quality standards. The objectives are to assure product quality and reduce batch variation. Types of liquid orals include solutions, suspensions, and emulsions. Critical process parameters for equipment, processing, and acceptance criteria are identified. The validation operations described include testing of raw materials and monitoring of outputs like appearance, pH, and content uniformity. A validation report is prepared and changes may require revalidation.
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Process Validation of Liquid Orals
1. PROCESS VALIDATION
OF LIQUID ORALS
Presented by :- Sachin R. Naksakhare
Roll no: 536
M.Pharm Sem-II (QAT)
Guide by:-
Dr. Rupali Kale
Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research Pimpri , Pune-18
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2. Introduction
Process Validation:-
Definition :-“It is a documented program which provides a
high degree of assurance that a specific process will
consistently produce a product, meeting its pre-determined
specifications and quality attributes”.
Process validation starts only after the complete qualification
program (D.Q., I.Q., O.Q., and P.Q.) of facilities and
equipment is over.
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3. To conform Manufacturing to cGMP regulations.
To avoid the possibility of rejected or recalled
batches.
To ensure the product uniformity and quality.
Why Process Validation?
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4. expected or expecting to be the
specified thing in the future
existing, happening, or done at the
same time
looking back on or dealing with
past events or situations
repetition of a validation process
Types of process validation
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5. Objective of process validation
Assurance of quality of the product.
Reduces variation between various batches.
Improve employee awareness for processes.
Easier maintenance of equipment.
Easier scale-up from development work.
More rapid and reliable start-up of new equipment.
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6. Advantages Of Process Validation
Simple process
Consistent through output.
Reduction in rejections and reworks.
Fewer complaints about process related failure.
Easier maintenance of equipment.
More rapid and accurate investigations process deviation.
Increased confidence about process reproducibility and product
quality.
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7. Critical Factors Of Process
Validation
All the critical point of the process should be clearly
identified.
The process should run using the extremes of the system at
the critical points.
The quality system should support the validation effort by way
of document control, preventive maintenance, calibration, etc.
Adequate data are required to provide statistical support to
demonstrate product consistency.
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8. What Are Oral Liquids?
Oral Liquids are homogeneous liquid preparations, usually
consisting of a solution, an emulsion or a suspension of one or
more active ingredients in a suitable vehicle.
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12. Manufacturing Of Biphasic Liquids
Water
Continuous
Phase
Other
helping
agents
Mixing
Aqueous
solution
Dispersed
Phase
For
suspension
Preservatives
Surfactants
Drug solution
in oil
Grinding of
Drug and
other solids
Dissolved
drug in oil
For
emulsion
Milled
drug 12
14. Objectives of process validation for liquids
To do the process
systematically to assure the
quality of the product
Ensures that the product meet
the predetermined
specifications
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18. TEST PARAMETERS FOR SUSPENSIONS AND EMULSIONS
TEST PARAMETER SUSPENSION EMULSION
Appearance √ √
Viscosity √ √
pH √ √
Content uniformity √ √
Sedimentation √ ˟
Re-suspendability √ ˟
Particle size √ √
Release rate √ √ 18
19. Operations in process validation
Raw material validation
1. Particle size and size distribution
2. Particle shape or morphology
3. Microbial count
4. pH of the solvent or vehicle
Monitoring outputs
1. Appearance
2. pH value and Viscosity
3. Microbial count
4. Content uniformity
5. Dissolution testing
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20. Validation Report
Validation Team must prepare
the report
Report must be reviewed and
approved by QA.
Written Notification or either
successful completion or
failure of the process
validation must be issued to
top management.
In case of failure, an
investigation must be
completed and documented
prior to repeat the validation
study.
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21. Changes and Revalidation
1. Minor
2. Intermediate
3. Major
Change of any of the following may need revalidation
1. Formula Composition
2. Raw Material Source
3. Manufacturing Process
4. Manufacturing Location
5. Equipments
6. Batch Size
CHANGES
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22. The accurate and reliable method of estimation quality, identity,
strength, purity, stability, effectiveness and safety.
The better acceptability of the drug.
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23. References
M. A. Potdar “Pharmaceutical Quality Assurance” Nirali
Prakashan, Thired edition, page no:- 8.20-8.22
M. A. Potdar “ cGMP For Pharmaceuticals” page no:- 469-484
Atmaram Pawar and R. S. Gaud “Modern Dispensing
Pharmacy” Career Publications, Page no:- 140-155
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