Product Development
Department
Many companies market have same
drug products, but not all are identical in context to physical parameters
which in turn affect the biological aspects like absorption and distribution of
a drug. Quality of a drug product depends on quality of formulation. Product
Development Department successfully does it all.
Functions
of Product Development Department
Æ Launching
of a New product
Æ Reformulation
Æ Reprocess
Æ Trouble
shooting
Æ Preparation
of B.M.R. for a new product.
Æ Development
of existing product.
New
Product launching:
For launching a new
product, product development department follow the following steps-
The pre formulation study consists of:
1.
Raw material specification
2.
Product specification
3.
Pharmacological action
4.
Toxicology
5.
Formulation
6.
Manufacturing
7.
Market product study: if the product is
new for our country or the product is exsting in the local market.
8.
Packaging.
9.
Stability testing
10.
Analysis
Development of existing
product:
Existing
products demand research in order to:
Ä Increasing
the quality of the product.
Ä Prevention
of any type of problem existing in the product.
Ä To
save time and cost.
Increasing the patient
acceptance
Reprocessing:
Reprocessing
is done for finished product if it fails quality control test due to shortage
of any excipient or active ingredient. In such case the finished product is
crushed and shortage amount is mixed is processed and a new BMR is prepared.
Trouble shooting:
Product Development also solves various in process
problem during a batch production.
Instruments available at PD core area
Granulation Room
Ä PMS
Fluid Bed Processor
Ä GHL
High Speed Mixer Granulator (SMG)
Ä Drum
Blender
Ä Electrical
Heater
Ä PMS
Granulator
Ä Electronic
Top Loading Balance
Ä Super
Mixer Grinder
Ä Vibro-Sifter
Ä Hot
Melt Granulator
Compression
Room
Ä Cadmach(CM3B)
Ä Hardness
Tester
Ä Hand
Filling Capsule Machine
Ä Mettler
Tolledo E. Balance
Ä Vacuum
Cleaner
Coating
Room
Ä Magnetic
Stirrer
Ä BOSCH
Stirrer
Ä Thai
Coater
Ä Coating
Machine (Kevin)
Wurster
Room
Æ Wurster
Coater
Core
Area
Ä Hot
Air Oven
Ä Hot
Air Sterilizer
Ä High
Shear Laboratory Mixer (Silverson)
Ä Adventurer
Electronic Balance
LCO
Æ Laminar
Air Flow Hood
Washing
and Sterilizing Area
Æ Water
Distillation Machine
Sterile
Filling Area
Ä Laboratory
Autoclave
Ä Laminar
Flow Unit
Ä Check
Station
Steps of
Product Development Personnel To Launching A New Product:
Phase: 01 - Information
[ NFD & Pre-NFD
information
Ä Fill-up
a pre-NFD form
Ä Approval
by engineering, production & QC department
Ä Approval
of NFD
Ä Send
approval NFD to PMD & QC
Ä Mention
if there are any other special criteria
Phase: 02 – Research
[ Literature Search & Project Planning
Ä Book
Research
Ä Internet
search
Ä Innovators
Web search
Ä PD
Project Planning
Ä Product
Development Requisition
[ Material Sourcing
Ä Sourcing
of active Raw material
Ä Potential
Supplier List
Ä Sample
for analytical development
Ä Reference
sample collection.
Ä API
analytical report.
Ä Excipients
testing (Special Items only) report
[ Active Purchasing/ Collection for PD
Ä Sourcing
of active Raw material
Ä Potential
Supplier List
Ä Support
of OSD
[ Active Testing &
Method validation
Ä Method
Validation for Active
Ä Method
validation for Finished Products
[ Pre-formulation studies
Ä Major Pre-formulation parameters of API
Ä Brand Products Formulation/Excipient Selection
Ä Binary Incompatibility study report
Ä Critical Pre-formulation research
[ Innovator’s/Brand Product
Purchasing
Ä Physician Desk Reference
Ä Out sourcing
[ Innovator’s/Brand leaders
Product Testing
Ä Physico-chemical
Testing
Ä Primary
Packaging component report
[ Primary Packaging
Material selection
Ä Incompatibility analysis with primary
packaging.
Ä Analysis
of Product Critical Factors
Ä Analysis
of Process critical factors
Ä Prototype
formulation
Ä Manufacturing
flow chart
[ Product Brief and
Specifications
Ä Drug
information Search
Ä Brand
and pilot batch Analysis Report
Ä Prototype
formulation
Ä BMR
of new product
Phase: 03 – Formulation
[ Lab batch & Stability Batch Preparation
Ä Preparation
of Laboratory Batch
Ä Packaging
of Laboratory Batch.
[ Analytical Evaluation of Finished Products
Ä Chemical
Analysis
Ä Physical
Analysis
Phase: 04 – Stability Study
[
Stability Study
Ä Stability
study report-1 Month
Ä Stability
study report-3 Month
Ä Stability
study report-6 Month
Review
and Specification Approval
Phase: 05 – Scalae-Up and Production
[ 1st Scale-up Batch Production
Ä Analysis
of 1st Scale-up Batch
[ 2nd Scale-up Batch Production
Ä Analysis
of 2nd Scale-up Batch
[ 3rd Scale-up Batch Production
Ä Analysis of 3rd Scale-up Batch
[ Process Validation & Reporting
Ä Process
Qualification
Ä Production
Facilities
Ä Production
& Packaging environment
Ä Batch
Documentation
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