Unit 1- Product Life Cycle Management

Question 1

the length of time a product is introduced to consumers into the market until it’s removed from the shelves.

Answer 1

Product Life Cycle

Question 2

Utilized by management and marketing professionals as a factor in deciding when it is appropriate to increase advertising, reduce prices, expand to new markets, or redesign packaging

Answer 2

Product Life Cycle

Question 3

→ The process of strategizing ways to continuously support and maintain a product.
→ This refers to the handling of a good as it moves through the typical stages of its product life.
→ This handling involves both the manufacturing of the goods and the marketing of it.

Answer 3

PLCM (Product Life Cycle Management)

Question 4

Helps inform business decision-making, from pricing, and promotion to expansion or cost-cutting.

Answer 4

Product Life Cycle

Question 5

4 PHASES OF PLC:

Answer 5

Stage 1: Product Development/Introduction
Stage 2: Product Growth
Stage 3: Product Maturity
Stage 4: Product Decline

Question 6

The product is losing market share or becoming obsolete. It is well past its point of highest demand and the demand decreases.

Answer 6

Stage 4: Product Decline

Question 7

The product is widely available, and there are many competitors in the marketplace. You market the product to different segments, but more spending on advertising will have no impact on its demand.

Answer 7

Stage 3: Product Maturity

Question 8

The product is more than an idea or a prototype.
The product is manufactured, marketed, and released.
Distribution increases, demand increases, and competition also increase.

Answer 8

Stage 2: Product Growth

Question 9

The new product is introduced. This is when all the research and development happens.

Answer 9

Stage 1: Product Development/Introduction

Question 10

How to Measure and Evaluate Your Product Life Cycle Management Program Signs to look into:

Answer 10

▪There are too many non-value add tasks
▪Your staff resumes some of their old practices
▪Not all the decisions are unanimous
▪Everything seems like it is urgent
▪Everyone is making decisions - there are no gates
▪You have bad data

Question 11

Metrics for PLC Evaluation Innovation:

Answer 11

Innovation
Lead Time
Cycle Time
Product Life
Product Waste
Product Reliability

Question 12

The total sales or revenue coming from new products.

Answer 12

Innovation

Question 13

The time from order to delivery.

Answer 13

Lead Time

Question 14

The time from production start to completion (including any testing).

Answer 14

Cycle Time:

Question 15

The length of time the product is usable by the customer.

Answer 15

Product Life

Question 16

The amount of waste per product produced.

Answer 16

Product Waste

Question 17

The amount of your product found to be flawed or faulty within a period.

Answer 17

Product Reliability

Question 18

Phase 1

Answer 18

Pharmaceutical Product Development

Question 19

Phase 2

Answer 19

Production of pharmaceutical products

Question 20

Phase 3

Answer 20

Market and sell of pharmaceutical products (Pharmacies, Hospital units)

Question 21

Phase 4

Answer 21

Recycling of expired pharmaceutical products

Question 22

Development

Answer 22

Clinical: Phase 1, 2 &3, Phase 4
Formulation
Delivery

Question 23

Marketing Authorization

Answer 23

e CTD application
HA queries management
Labeling development and Launch plans

Question 24

Post Approval commitment

Answer 24

Safety: PV, PSUR, safety update
Stability
Renewals

Question 25

Variation Management

Answer 25

Site transfers
CMC changes
MAH transfer
New Indication

Question 26

ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

• ICH Q12 Expert Working Group
Diversity of technical expertise (small and large molecule, development, manufacturing, quality and regulatory, assessors and inspectors)
• Good collaboration, team commits to address difficult topics
-Q12 EWG team members (current status):
o EU/EMA, EFPIA, Swissmedic, APIC, FDA, PhRMA, Health Canada, IGPA, BIO, MHLW/PMDA, JPMA, WHO, WSMI, DOH Chinese Taipei, DRA Singapore

Scope of the Q12 Guideline: All pharmaceutical products including currently marketed chemical, biotechnological and biological products

Answer 26

N/A

Question 27

MAH

Answer 27

Marketing Authorisation Holder

Question 28

Notification

Answer 28

A change to an approved established condition that does not require approval prior to implementation.

Question 29

PACMP

Answer 29

Post-Approval Change Management Protocol

Question 30

PLCM

Answer 30

Product Lifecycle Management

Question 31

Post-approval CMC commitment

Answer 31

Commitment by the MAH to undertake specific CMC activities to be implemented during the commercial phase.

Question 32

Prior approval

Answer 32

Change to an approved established condition that requires regulatory review and approval prior to implementation

Question 33

PQR

Answer 33

Product Quality Review - regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements

Question 34

PQR

Answer 34

Product Quality Review - regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements

Question 35

QRM

Answer 35

Quality Risk Management

Question 36

Submission

Answer 36

Communication to a regulatory authority regarding a change to an established condition that could be prior approval or notification.