1. GMP, QA AND
VALIDATION
OF
EMULSIONS
PRESENTED BY -
SHRAVAN PASWAN
paswanshravan@gmail.com

2. CONTENTS
1.Introduction
 Advantage
 Disadvantage
 Application
2. GMP-
 Building and personal, raw materials
 Equipments, process, package
 Label, containers $ closures
 IPQC
3. Quality control
4.Quality assurance
5. stability( USFDA GUIDELINE)
5. Validation
6. Conclusion
7. References

3. 1. Emulsion
An emulsion is a thermodynamically unstable system consisting of at least two
immiscible liquid phases, one of which is dispersed as globules in the other
liquid phase, stabilized by the presence of an emulsifying agent.
The phase that is present as fine droplets is called the disperse phase that is
present as fine droplets is called the disperse phase and the phase in which the
droplets are suspended is the continuous phase.

4. 2. Pharmaceutical
applications of emulsions
 Many medicinal agents have objectionable taste or texture,
as a result mineral oil based laxative, oil administered as
O/W emulsion.
 W/O emulsions are employed more rudely for treatment of
dry skin & emollient application.
 Used for intravenous administration of lipid nutrients.
 Radio opaque emulsions have been used as diagnostic
agents in X-ray examination.
 W/o emulsions have been employed to disperse water
soluble antigenic materials in minerals oil for intramuscular
depot injection

5. Advantage &
disadvantage
ADVANTAGE DISADVANTAGE
Patient acceptance is more. Creaming and
sedimentation
Emulsion posses a certain clergies of Cracking
elegance and easily washed off
whenever required.
Emulsions possess an important cost Phase inversion
advantage over single phase
preparation.

6. 3. Emulsion types and
identification tests
Types
 Oil-in-water (OW) eg.Gum acacia
 Water-in-oil (W/O) eg. lotion & cream
 Oil-in-water-in-oil (O/W/O)
 Water-in-oil-in-water (W/O/W)
Identification tests of O/W or W/O
 Dilution test
 Dye test
 CoCl2 filter Paper test
 Fluorescence
 Conductivity

7. GMP
 Adequate space for equipment
 Proper light ,water & drainage facilities
 Adequate labors force
 Trained & qualified personal
 Manufacturing should be under proper conditions
 Proper control measures should be taken
 Equipment design ,size & location
 Proper cleaning and maintenance

8. Raw materials
 Emulsifying agents reduces interfacial tension
eg. Benzalkonium chloride
 Density modifiers prevents drying eg. Glycerol
 Antioxidants protects oils & fats eg. Tocopherol ,
gallic acid
 Sweetening agents eg. Vanillin , benzaldehyde
 Preservatives are rapid in action eg. Benzoic acid +
chloroform

9. Equipment
 Equipment design, size & location
 Equipment construction
 Equipment cleaning & maintenance
 Proper spacing between equipments
 Automatic, mechanical & electronic equipment
Processing
Continental or dry gum method
English of wet gum method

10. Packaging material
 CONTAINERS -
Plastic - a) Thermoplastic
b) Thermosetting
Metals – a) Aluminium
b) Stainless steel
c) Tinplated steel
 CLOSURE –
Threaded screw cap
Roll on
Torque
Closure Liner
Friction

11. LABELLING
SPECIAL LABELLING & ADVICE FOR EMULSIONS:--
 Shake well before use
 Store in a cool place
 Expiry Date
 For external use only
Shelf Life & Storage:---
 Store in a cool dry place
 Labelled as “ Cod Liver Oil 30% V/V emulsion.”
Advice & Labelling:--
 A normal dose in 10 ml 3 times a day with or after meal.

12. IPQC
 Phase inversion temperature
 Low energy emulsification
 Timing
 heat

13. Quality control &
Quality assurance
 Reduction in density difference between two
phases
 Increase in viscosity of continious phase
 Production of small droplet size
 Adverse storage condition
 Microbial contamination
 Coalescence
 Flocculation
 Creaming

14. Preservation of
emulsions
 Growth of microorganisms in emulsions
 Preservatives should be in aqueous
phase.
 Preservatives should be in unionized
state to penetrate the bacteria
 Preservatives must not bind to other
components of the emulsion

15. VALIDATION
 Documented process,which provides high degree of
assurance that a specific process will consistently
produce,a product meeting its pre-determined
specification & quality attributes.
 Obtained through the collection & evaluation of data.
 Importance of validation –
1)Reduction of quality cost
2)Process optimization
3)Assurance quality
4)Safety
 Limitation of validation –
Validation has a practical limit and related cost.

16. CONCLUSION
 Pharmaceutics is a tool of whose potential appears
limitless the word pharmaceutics is used in pharmacy
& pharmaceutical sciences to encompass many
subject areas, which are all associated with the steps
to which a drug is subjected towards the end of its
development my project has undergone on one such
topic of pharmaceutics i.e. emulsions.
 In the project I have tried to dealt with the various
emulsions procedures like its introduction, uses, GMP,
manufacturing procedures etc. this project
concentrates on various subjects related to emulsions .

17. REFERENCES
 Jain, Akalank Kumar “Drug & Cosmetic” Publish by Akalank
Publication edition 8rd 2006
 Martin Alford, “physical pharmacy” B. I. Publication Pvt.Ltd. IVth
edition Indian Reprint 1994, Reprint 2004.
 Aulton M.E “Pharmaceutics the Science of Dosage form
Design” Published by Churchill Livingstone, Edition IInd.
 Lachman L., Lieberman H.A, Kanig J.L, Theory and Practice of
Industrial Pharmacy, Lea & Febiger, Philadelphia, U.S.A..
 Nash, Robert A & Wachter Alfred H “Pharmaceutical Process
Validation an International, edition IIIrd Valume-29
 www.google.com
 www.jyoticapsule.com
 www.pharmamachine.com
 www.pii.com
 www.capssugel.com

18. THANK YOU