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.

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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9. 1. Topically
2. Orally
3. Parentrally (S.C., I.M., I.V.)
Liquid Dosage Forms Can Be Administered
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10. Classification Of Liquid Orals
Liquid orals
Monophasic
Solutions
Linctuses
Elixirs
Syrups
Liquid drops
Biphasic
Suspension
Emulsion
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11. Manufacturing Of Monophasic
Liquids
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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

13. Continuous
Phase
Dispersed
Phase
Pre-mix or crude
Dispersion
Fine Dispersed
Delivery System
pH adjustment
Other additives
(flavors and
coloring agents)
Volume
adjustment
Homogenize
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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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15. Validation Of Liquid orals
1. Equipment
2. Raw materials
3. Compounding
4. Microbiological quality
5. Oral suspension uniformity
6. Product specifications
7. Stability
8. Packaging
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16. Critical Parameters
Equipment
Mixing speed
Homogenizing speed
Mixing time
Heating/ cooling time
Flow rate
Processing
Mixing speed
Mixing time
Cooling time
Homogenizing speed
Homogenizing time 16

17. Acceptance Criteria
Dissolved
active
ingredient
Clear solution
Filtration No residue on filter
pH
adjustment
pH within specification
Final mixing
pH, viscometer,
appearance, assay
content 17

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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24. Thank
You
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