Process Validation of Ointment Creams

 

A SEMINAR ON

PROCESS VALIDATION OF OINTMENT/CREAM FORMULATION

 

Why need of process va!da"!on for •

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o!n"#en"$crea#%

Product bio burden Product bu rden high? Multiple component? More adequate preservative preservative system? All have Netonian !o behavior?

History " #inc o$ide rash cream that as heated to a relatively high temperature solely by the action o% rotating rotating mi$ing plate&

 

Ointment  •

So%t' semisolid preparation intended %or application to s(in and mucus membrane&

 Appearance  Appearance"" Opaque

 )ype ype"" Oleaginous bases  )   Absorption bases    

Emulsion bases *ater soluble bases

Cream •

+iscous emulsion o% semisolid consistency intended %or application to s(in and mucus membrane&

 Appearance" )ranslucent  Appearance"  )ype ype"" oil,in,ater-o./  )   ater,in,oil-.o/

 

#&s" 'e va!da"ed !n 0 Processes #&s" 'e phar#ace&"!ca #an&fac"&r!n( are) 1leaning Saniti2ation

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3umigation 4epyrogenation Sterili2ation Sterile 5lling

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3ermentation 6ul( production Puri5cation 3illing' capping' sealing 7yophili2ation

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Process Va!da"!on •

4ocumented evidence' a high degree o% assurance that a speci5c process process   ill consistently produce a product that meets its predetermined speci5cation characteristics&

and

quality

 

Process +alidation Program

 

cont&&

 

Process va!da"!on •

*89 EN3OR1E I)?

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*8EN IS I) PER3ORME4?

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*8O PER3ORMS I)?

 

Why% •

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Ma(es Ma( es good engineering sense& Results in %%eer eer product recalls and troubleshooting assignments in manu%acturing operations& Results in more technically and economically sound products and their manu%acturing processes&

 

When% Deveop#en" s"a(e

*a"ch s!+e

Product design

:; batch si2e

Product characteri2ation

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3ormula selection Process design

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Product optimi2ation

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