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Now you have full access to the PDF document library. I will not personally recommend you to limit your thoughts based on the interpretation of what I have mentioned in the document. You can use these papers as a key document or idea to initiate your brainstorming based on your product or process specific scenario. Happy Reading !
Survey of Moist Heat Terminal Sterilization
Review on the moist heat terminal sterilization process.
Industrial Data Integrity case study
Untouched area of Data Integrity in Pharmaceutical Industry
How different automation and manual activity
Troubleshooting in pharmaceutical industry automation Vs Manual
Techno Gear
First issue (revision 00) of PRES technical guidance magazine
Success Mantra for pharmaceuticals
A thought process to improve Pharmaceutical operation through collaboration
Sterilisation Math
Understand physical and biological lethality calculations.
BI used for Filling line Isolator
Rationale for using triplicate biological indicators during VHP decontamination in Isolator
FMEA Purified Water system
Purified Water generation and distribution system criticality assessment
Validation plan for Depyrogenation tunnel
One Slider for Qualification and validation of depyrogenation and sterilization tunnel
Residual seal force (RSF)
Importance of Residual seal force (RSF) for establishing Vial capping parameter
Remote Inspection readiness
Hosting remote inspection at pharmaceutical facilities considering COVID travel restrictions
Hand Book for Fish Bone
Get classic examples of different Fish bone evaluation
Isolator Gloves Maintenance
Guidance on the best practices for isolator gloves maintenance
Global Challenges for Indian Pharmaceutical Industry
A white paper on the Global Challenges for Indian Pharmaceutical Industry.
US FDA inspection readiness
A white paper on the reediness of the upcoming inspection at your facility
FMEA on HVAC system
Failure mode analysis for HVAC system
F0 and Equivalent exposure time of sterilisation
Guidance to evaluate and compare between F0 and Exposure time at 121 degree centigrade temperature
483 on “Injectable Visual inspection program”
Discussion on the 483 observation provided by FDA for visualization inspection of injectables
Quality risk management for Critical equipment
Presentation on the risk management for the critical Equipment use in manufacturing environment
Visula Inspection Program
A Review Article on Visual Inspection program for sterile injectable product
An Approach To Review CPMS
About continues particle monitoring system (CPMS) installed at Grade A
Dead or Alive
Death kinetics of Microorganism during moist heat sterilization process
Cool Zone Sterilization in Tunnel
Whitepaper on the cool zone sterilization for Depyrogenation and sterilization tunnel
Guidance on Sterile filling Line isolator
Design, qualification and operational approach for Aseptic processing Isolator
Depyrogenation Tunnel - Myth or Facts ?
Exposure of 3 min at 300 degree is necessary for Performance Qualification?
Aseptic or Terminal Sterilization ?
Difference between Aseptic and Terminal sterilization Process.
Q&V Manual
Qualification and Validation Manual for sterile drug manufacturing
Download editable copy
Purified Water generation and distribution system criticality assesment
FMEA Approach on Purified Water generation and distribution system
HVAC & BMS controls criticality assessment
FMEA approach on HVAC & BMS controls