Lesson 2: Introduction to Product Life Cycle Management

Product life cycle management

Is a holistic approach to manage products from early concept through all stages of development and production to the end of product life

ICH

• Has gradually evolved, to respond to the increasingly glocal face of drug development

• Its mission id to achieve greater harmonisation worldwide to ensure that safety, effective, and high quality medicines are developed and registered in the most resource efficient manner

Stability

ICH Q1A-Q1F

Analytical validation

ICH Q2

Impurities

ICH Q3A-Q3D

Pharmacopeias

ICH Q4 -Q4B

Quality of Biotechnological Products

ICH Q5A-Q5E

Specifications

ICH Q6A-Q6B

Good manufacturing practice

ICH Q7

Pharmaceutical development

ICH Q8

Quality risk management

ICH Q9

Pharmaceutical quality system

ICH Q10

Development and manufacture of drug substances

ICH Q11

Product lifecycle management

ICH Q12

Quality by design

• A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management

• Means designing ans developing manufacturing processes during the product development stage to consistently ensure a predefined quality at the end of the manufacturing process.

• A quality system provides a sound framework for the transfer of process knowledge from development to the commercial manufacturing processes and for post development changes and optimization

Quality target product profile

• A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product

Critical quality attribute

• A physical,chemical, biological or microbiological property that should be within an appropriate limit, range or distribution to ensure the desired product quality

Critical process parameters

• A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure that the process produces the desired quality

Ishikawa diagram

Is a diagram that shows the causes of an event and is often used in manufacturing and product development to outline the different step in a process, demonstrate where quality control issues might arise and determine which resources are required at specific times

New drug

• New/noble discovery

• Sysnthesis of existing biological/botanicals

• New use/application of known drugs/chemicals

• Modification of existing drugs

• New excipients

• Isolation of active principles

• New dosage form for new route of administration

• Synergistic combination

• Literature survey

• Natural products

• Gene therapy

• Formulation studies

• Chemical synthesis

• Study patents

• Budget and procurement consideration

• Market researches

• Statistical studies

• Laboratory

• Accidents

Sources of Ideas

Pre-discovery

Is the stage of research involving the understanding the disease, target identification and target validation. The research can take up to 6 years

Drug discovery

Is the stage of finding the lead compound, the promising molecule. During this stage, scientist analyze 5,00-10,000 natural and synthetic compounds made in labs or through bioengineering to narrow it down to a single targeted compound or biologic

Preclinical testing

• Is the extensive laboratory testing to determine initial safety and efficacy of new therapeutics.

• This stage includes in vitro and in vivo pharmacological tests, scale up, toxicological tests, biopharmaceutical tests, and environmental safety tests

Clinical testing

Takes place after IND application is submitted

Phase 1

• Uses healthy volunteers to determine drug tolerance and toxicity.

• A simple hard gelatin capsules formulatiion containing the API is usually used for the IND studies

Phase 2

• A limited number of patients with the disease or condition for which the drug was developed are treated under close supervision

• Dose response and safety studies are performed

• A final drug formulation is developed

Phase 3

• Are performed with the final dosage form developed in Phase 2

• Studies are done in a large patient population with the disease or condition

• Side effects are monitored

NDA

Is submitted to the FDA for review and approval after clinical trials

Post marketing surveillane

Is also known as phase 4. After the FDA grants market approval of the drug, product development may continue