SHELF LIFE

PRODUCT REMAINS

STERILE & FUNCTIONAL

SHELF LIFE

• ENVIRONMENT

  - BIOBURDEN (AIR & SURFACE)

  - AIR FLOWS

  - PERSONNEL TRAFFIC PATTERN

  - STORAGE LOCATION

  - TEMPERATURE

  - HUMIDITY

• TIME :

  WE THINK, BUT IT IS REALLY NOT IT IS EVENTS & THEIR FREQUENCY

• PROCESS 

• PRODUCT 

• TRANSPORTATION & HANDLING

QUSTIONS BEFORE US 

• Who understands requirements

  - Customer                               NO   

  - Manufacturer                          NO   

  - Regulatory Agencies               NO                      

• Are we tuned to Developments   NO

CHALLENGE BEFORE US

• ISO 9000 (2000)

• WHO GMP

• CE MARKETING

• US FDA

Are we READY TODAY?                  `NO'

WHAT NEEDS TO BE DONE

That is why we all are here, let us start discussion