Product Development Process

Product Development Process

• The product development process of an

establishment should be established and
approved by management to ensure
smooth flow of activities.
• It is also very important to assign
responsible parties to each activity
• Tracking of the development process
should be conducted
NEW PRODUCT DIRECTION ISSUED

Action Party: Sales & Marketing

New product direction to include
benchmark samples, target cost,
packaging materials to be used,
product form, product claims,
estimated launch quantity and
delivery/launch dates
 FEASIBILITY REVIEW

Action Party: Sales & Marketing, R&D,

Regulatory Affairs
• Concerned parties to discuss
feasibility of the product. A
development timetable for the product
shall be prepared.
 PRODUCT DEVELOPMENT
(formula and packaging)
R&D to do the ff:
• Provide list of raw materials for
sourcing to Sourcing Department
• Prepare laboratory batches for
approval
• Provide samples for usage tests and
clinical testing
 PRODUCT DEVELOPMENT
(Formula and packaging)
R&D to do the ff:
• Establish product shelf-life by
accelerated stability studies and
compatibility tests with packaging
materials
 PRODUCT DEVELOPMENT
(Formula and packaging
SALES and MARKETING to do the ff:
• Define final product and packaging
specifications
• Provide approved packaging
materials to QA, approved laboratory
batch samples to R&D, and standard
samples to Production for reference
 PRODUCT DEVELOPMENT
(Formula and packaging)

SALES and MARKETING to do the ff:

• Provide client feedback and
evaluation to R&D (if applicable)
 PRODUCT DEVELOPMENT
(Formula and packaging
SALES and MARKETING to do the ff:
• Provide product and label claims based on
ingredients (if required).
• Provide ingredients list for packaging
copy.
• Issue technical documents to client
(ingredients list, product claims, Part I of
PIF documents)
 PLANT VALIDATION
Action Party: R&D, Production, QA
• Manufacturing feasibility studies
completed. The machines for the products
shall be established by R&D and
Production
• Manufacturing documents issued by R&D
• Pilot production batches produced and QA
documents/standards established.
 LEGAL AND REGULATORY

Action Party: Sales & Marketing, R&D,

Regulatory
• Legal requirements such as patents,
trademarks and tradenames handled
by client
 LEGAL AND REGULATORY

Action Party: Sales & Marketing, R&D,

Regulatory Affairs
• Notification requirements issued by
Regulatory affairs (list of ingredients
for packaging copy, qualitative and
quantitative formula, function &
percentage of restricted ingredients)
 FINANCIAL ANALYSIS

Action Party: Cost Accounting

• Product cost to be determined based
on packaging, formula and
manufacturing costs by Cost
Accounting
 PRODUCTION
Action Party: R&D/Production/QA
• R&D to monitor first three commercial
batches. Product properties to be
checked by QA
• R&D to adjust manufacturing
documents, formula and
specifications if required.
 QUALITY ASSURANCE

Action Party: Sales and Marketing,

R&D, QA, Production
• Sales/Marketing to provide client
approved samples to QA for
inspection reference
• R&D to provide specification sheets
to QA
 QUALITY ASSURANCE
• QA to provide test results to R&D for
three production batches
• QA to conduct real-time stability
studies (after compounding and every
six months until the expiry date is
reached); and provide copies of
stability test results to R&D for any
variation in specifications
 POST-LAUNCH EVALUATION

Action Party: Marketing/Sales

• Sales and Marketing to provide client

and consumer feedback.
 PRODUCT PROFILE
The following information shall be indicated in the product
profile:
• Product name/description, Date Issued,
Launch date, Issued by,
Product Claims, Benchmark, Target Price
• Primary (bottle, jar, etc.) Packaging directions/specifications
• Secondary (labels, boxes, etc.) Packaging
directions/specifications
• Initial order quantity/forecast
• Other directions:
 PRODUCT AND PACKAGE
EVALUATION FORM
The following information shall be indicated
in the product and package evaluation
form:
• Item name, Item description, Date
submitted, Submitted by
• Properties, comments/evaluation, Final
disposition
• Evaluated/approved by, date