Food And Drug Administration Science Advisory Board Meeting - Nov 16 2001 Pharmaceutical Industry -...

Food And Drug AdministrationScience Advisory Board Meeting - Nov 16

2001Pharmaceutical Industry - where to?Pharmaceutical Industry - where to?

• More real time process controlMore real time process control

• More real time non destructive product testingMore real time non destructive product testing

• Parametric releaseParametric release

Expected ResultsExpected Results

• Higher product quality and securityHigher product quality and security

• Substantial cost reductionSubstantial cost reduction

• Benefits to share holdersBenefits to share holders

• Benefits to the publicBenefits to the public

CAN WE LEARN FROM OTHER INDUSTRIES?CAN WE LEARN FROM OTHER INDUSTRIES?

Pharmaceutical IndustryPharmaceutical Industry Aircraft Engines Industry Aircraft Engines Industry

• Both “hold” people’s lives in their hands Both “hold” people’s lives in their hands • Both are Federally regulatedBoth are Federally regulated• Both are very competitiveBoth are very competitive• Both drive their products to extreme performance limitsBoth drive their products to extreme performance limits• Both are being “chased” by generic productsBoth are being “chased” by generic products• Both are driven to lower prices by government and users Both are driven to lower prices by government and users


2001


2001


Aircraft Engine Industry in the mid-1970’sAircraft Engine Industry in the mid-1970’s

• Product testing - Major Quality thrust during productionProduct testing - Major Quality thrust during production

• P&W incoming/in-house testing lab - 600 people at East Hartford onlyP&W incoming/in-house testing lab - 600 people at East Hartford only

• Ratio inspectors/operators - about 2 to 3Ratio inspectors/operators - about 2 to 3

• Operators not responsible for quality - inspectors areOperators not responsible for quality - inspectors are

• Statistical Process Control - non existentStatistical Process Control - non existent

• Scrap factory - about 20 to 30%Scrap factory - about 20 to 30%


2001CAN WE LEARN FROM OTHER INDUSTRIES?CAN WE LEARN FROM OTHER INDUSTRIES?

Aircraft Engine Industry since the early-1980’sAircraft Engine Industry since the early-1980’s

• Active and statistical process control - Major Quality thrust (TQM)Active and statistical process control - Major Quality thrust (TQM)

• P&W incoming/in-house testing - 100 people world wideP&W incoming/in-house testing - 100 people world wide

• Ratio inspectors/operators - about 1 to 8Ratio inspectors/operators - about 1 to 8

• Operators responsible for quality Operators responsible for quality

• Scrap factory - down to 5 to 8%Scrap factory - down to 5 to 8%

• Quality - dramatic increase, engine failures became rareQuality - dramatic increase, engine failures became rare

• Cost - dramatic reduction (typical cast blade down by factor of 3-4)Cost - dramatic reduction (typical cast blade down by factor of 3-4)


2001


Pharmaceutical Industry TodayPharmaceutical Industry Today

• Product testing - Major Quality thrustProduct testing - Major Quality thrust

• On line active process control - minimalOn line active process control - minimal

• Ratio QC /operators - about 1 to 2????Ratio QC /operators - about 1 to 2????

• Statistical Process Control - practically non existentStatistical Process Control - practically non existent

• Scrap factory - ????Scrap factory - ????

• Still too many recalls - about 200 per year.Still too many recalls - about 200 per year.

• Product uniformity - still an unresolved issueProduct uniformity - still an unresolved issue


2001


Engine Industry - Drivers for ChangeEngine Industry - Drivers for Change

• Government and customer pressure to reduce cost to own/operateGovernment and customer pressure to reduce cost to own/operate

• Competition for performanceCompetition for performance

• Pressure to maintain profitability/share ownersPressure to maintain profitability/share owners

• Sense of “dead end” in doing more of the sameSense of “dead end” in doing more of the same

• FAA provided strong support anticipating the benefits to the publicFAA provided strong support anticipating the benefits to the public


2001

CONCLUSIONCONCLUSION

THE PHARMA INDUSTRY WILL FOLLOW THE SAME THE PHARMA INDUSTRY WILL FOLLOW THE SAME PATH TAKEN BY THE AIRCRAFT ENGINE INDUSTRY IN PATH TAKEN BY THE AIRCRAFT ENGINE INDUSTRY IN ITS BID TO MORE COST EFFECTIVE AND ABOVE ALL :ITS BID TO MORE COST EFFECTIVE AND ABOVE ALL :

MORE PROFITABLEMORE PROFITABLE


2001

FACTSFACTS

•The Same drivers for change are thereThe Same drivers for change are there

•The FDA is providing increasing support realizing theThe FDA is providing increasing support realizing the benefits to the public benefits to the public

•The industry is getting the sense of “dead end” doing The industry is getting the sense of “dead end” doing more of the same more of the same


2001

HOW?HOW?

• There is more than one tool, but NIR is probably the most There is more than one tool, but NIR is probably the most significant of themsignificant of them

• Success will create new and improved tools, soon we will not Success will create new and improved tools, soon we will not understand how it could be otherwiseunderstand how it could be otherwise


2001

WHY IS NIR SO IMPORTANT?WHY IS NIR SO IMPORTANT?

• It is the only method that provides significant chemical and It is the only method that provides significant chemical and physical information of the bulk of the product, not just physical information of the bulk of the product, not just surfacesurface

• It is the only method to allow transmission through tablets It is the only method to allow transmission through tablets and capsules for complete bulk characterizationand capsules for complete bulk characterization

• It provides information on all ingredients, not just the activeIt provides information on all ingredients, not just the active


2001

2 - 4 mm

Depth of penetration and collection of reflected light depends on density and wavelengths. At NIR wavelengths, depth can easily reach 4 mm and more. “Sample” size is a combination of depth and illuminated area


2001

WHY IS BRIMROSE AOTF-NIR SO IMPORTANT?WHY IS BRIMROSE AOTF-NIR SO IMPORTANT?

• It is fast - 30 scans/sec (excellent wavelength repeatability)It is fast - 30 scans/sec (excellent wavelength repeatability)

• It is extremely rugged - can drop to the floor and still operateIt is extremely rugged - can drop to the floor and still operate

• It is dual beam for real time ratioIt is dual beam for real time ratio

• It is full scanning to provide information on all ingredients, not It is full scanning to provide information on all ingredients, not just active (and process all algorithms on board)just active (and process all algorithms on board)

• It is miniaturized to do blenders (battery operated)It is miniaturized to do blenders (battery operated)

• It is insensitive to ambient light variationsIt is insensitive to ambient light variations

• It is backed by 21CFR11 tested software from BrimroseIt is backed by 21CFR11 tested software from Brimrose


2001

WHY IS BRIMROSE AOTF-NIR SO IMPORTANT?WHY IS BRIMROSE AOTF-NIR SO IMPORTANT?

THE ONLY ANALYZER THAT CAN DO THEM ALL, FROM A TO ZTHE ONLY ANALYZER THAT CAN DO THEM ALL, FROM A TO Z

• Incoming raw materials Incoming raw materials

• Fluidized bedsFluidized beds

• Rotating blendersRotating blenders

• Tablets and capsulesTablets and capsules

• Vials, lyophilizersVials, lyophilizers

• Spray dryersSpray dryers

• Blister packsBlister packs

• Transdermal patchesTransdermal patches


2001


2001

16” (400)

18” (450)


2001

Food And Drug Administration Science Advisory Board Meeting - Nov 16 2001 Pharmaceutical Industry -...

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