Research & Development Dept.

and New Product Development

A Basic Concept

Prepared by: Riaz Ali

Head R&D (Don Valley Pharmaceuticals, Lahore, Pakistan)
riaz.pharmachemist@gmail.com
 Contents
Contents:
1. Role of R&D in industry
2. New product development
project declaration
project feasibility
3. Working on new product development
Phase 1: Literature Search
Phase 2: Raw material characterization
Phase 3: PD & AMD
Phase 4: Analytical Method Validation/verification
Phase 5: Exhibit batch manufacturing, testing and
charging of samples at stability
Phase 6: Technology Transfer
 Role of R&D
• 1. The backbone of an industry
• 2. The business growth depends upon the
R&D
• 3. Stronger the R&D, greater the revenue
• 4. A good sign of industry’s reputation
• 5. We can handle problems at R&D platform
identified by market or govt. So, it reduces the
chances of product rejection and loss.
 New Product Development
Project declaration based on:
• 1. local market need
• 2. export market
• 3. on any urgent basis by regulatory or govt.
Project Feasibility Determination:
To check if it is possible to carry out the project
in our facility so that we can save ourselves from
the loss of energy, resources and money
 Working on Project
Phase 1:
Literature Search
1. Innovator’s product study
2. Formulation Study
3. Research papers to find evidences of formulations and
testing method
4. To study from sites of different regulatory bodies about
the formulation and analytical method
5. To study the regulations imposed by drug regulatory
bodies for registration of product
 -Continued-

Phase 2:
Raw Material Study (API & Excipients):
1. QC testing
2. DMF study
3. API validation data
4. API CoA from manufacturer
5. Drug Excipients compatibility study
 -Continued-
Phase 3:
It has further 2 parts:
Phase 3A:
Trial batch manufacturing
1. There should be 3 trial batches one after the
other in order to confirm the formulation
2. If there is a problem, then the trial manufacturing
should be continued on trial and error basis until
the optimized and robust formulation and
manufacturing process are obtained
 -Continued-
Phase 3B:
Analytical Method Development (AMD) for the testing of trial product
and for RLD Characterization:
1. The proposed method should be such that it produces reliable and
robust results on the trial batch.
2. If there is a problem in testing method, the method should be
optimized until a robust and reliable method is developed.
3. The innovator’s product called RLD should also be tested along
with the trial batch using the same method in order to determine
if:
1.there is a compatibility between both the products
2.the method is applied accurately on both the products.
4. The RLD study will be called as RLD characterization. A separate
report will be prepared for RLD characterization.
 -Continued-
Finalized formulation, manufacturing process and testing method:
1. Once finalized, PD and AMD protocol will be prepared and a
final trial batch will be manufactured and will be tested as per
their respective protocols.
2. The samples of final trial batch will undergo stress study for 7
days in order to determine how much our product is stable.
3. Meanwhile, we will conduct forced degradation study on the
final trial samples to identify the impurities generation and any
degradation.
4. Specificity study will be also carried out at this stage in order
to identify each and every substance in the product.
5. System suitability criteria will also be defined at this stage.
 -Continued-
GO, NO GO DECISION:
1. If there will be problem in the results of stress
study, forced degradation and specificity at
this stage, then we will start study again on
product starting from phase 3 and study will
be continued until we get suitable results.
2. If the results and product behavior is found
okay at this stage, then the PD and AMD will
be closed with their proper final reports and
we will move towards phase 4.
 -

Phase 4:
Analytical Method Validation/ Verification
1. It will be carried out to determine if the developed
method is suitable for its intended purpose.
2. A protocol will be prepared to carry the AMV.
3. Following parameters will be performed for AMV:
System Suitability, Batch Analysis, Specificity, forced
degradation, linearity, accuracy, LOD/LOQ (for impurities),
precision and repeatability, intermediate precision, solution
stability and robustness.
4. Analytical method validation/ verification report will be
prepared after performing all the parameters.
 -
Phase 5:
Exhibit Batches:
1. After the successful completion of AMV study,
exhibit scale batches will be manufactured.
2. They will be tested as per the final testing
method.
3. If the results of the exhibit batches are found
within limit, the samples of the batches will be
placed in stability chamber to carry out
stability study.
 -

Phase 6:
Technology Transfer:
1. The tech transfer activity will be performed
and the technology will be transferred, at
commercial level to production and Quality
Control, with all the development data. This all
will be done as per a tech transfer protocol.
2. In case the tech transfer is for abroad
company, there will a separate tech transfer
protocol.
 -

After the technology transfer has been

transferred, the product is ready for
manufacturing for commercial market.
 -

Process Flow in Short:

Literature Search →
Raw Material Characterization →
Product Development & Method Development→
Analytical Method Validation →
Exhibit Batches manufacturing, testing and charging
of samples at stability →
Technology Transfer
 -

Thank You