All products and services have certain life cycles. The life cycle refers to the period from the product’s first launch into the market until its final withdrawal. During this period significant changes are made in the way that the product is behaving into the market i.e. its reflection in respect of sales to the company that introduced it into the market. The understanding of a product’s life cycle can help a company to understand and realize its position in the market compared to competitors and the product’s success or failure.
Today’s current challenge within the pharmaceutical industry is to focus on Product Lifecycle Management (PLM) and it is a business transformation approach to manage products and related information across the industry. Pharmaceutical industry is looking at more holistic approaches to improve processes to bring new products to market that can accelerate product development while lowering operational costs.
This is challenging because of the complex value chain and business processes required in this highly regulated environment. Being able to aggregate and analyze all elements of a given compound or drug from a central location allows pharmaceutical companies and their partners to quickly address industry challenges. In this article we have tried to highlight key challenges in pharmaceutical product lifecycle management which are as follows -
Increasing Internal and External Complexity
In managing the entire product lifecycle from product inception to phase out, the simple fact is that that many pharmaceutical organizations suffer from silos of information across the different functional areas leading to different complexities.
No Single Data Source for Products and Related Information
Due to a variety of different data sources and lack of collaboration across the organization often results in disparate, redundant and inaccurate product information depending on functional area.
Research and Development Improvement
Opportunities exist in increasingly competitive landscape for innovative pharma companies looking for transforming their business that lead to profitability and growth. Companies that successfully manage the transformation process to address these challenges will realize improved business performance and differentiation in the market place and technology.
Production of drug product is highly iterative hence control must be established for each lot from scale-up, validation, quality assurance till commercialization of the final approved product. Effective scale-up of drug production requires collaboration across many interrelated activities and dependences.
Integrated Quality and Risk Management
Quality and risk management continues to be a challenge creating significant business impact when deficiencies are identified during regulatory audits. An effective Enterprise Quality Management requires the integration and management of quality beginning from product development to commercialization.
Pharmaceutical packaging is highly regulated and must focus on product safety, integrity and ingredients as well as adverse event labeling. International distribution also forces pharmaceutical companies to address multiple regulatory and language requirements as well as counterfeit controls. In today’s highly competitive environment, controlling costs and maintaining maximum flexibility is vital to a drug’s commercial success. Creation of a global repository for all packaging components, digital assets such as logos and artwork and marketing collateral that references development evidence will improve regulatory integrity of all associated commercial content.
Global Product Registration
This is complex, constantly evolving and making drug molecule registration management difficult. This creates delays in market launch and significantly impacts the anticipated product revenue.
Intellectual Property Portfolio
A significant amount of time under patent protection for a new drug is typically consumed in clinical trial and regulatory approval phases. To remain competitive, pharmaceutical companies must bring a portfolio of new drugs and drug extensions to market more quickly to take advantage of the patent protected period.
Managing Complex Collaborative Outsourcing Networks
Pharmaceutical companies rely more heavily on contract service providers to maximize efficiencies, focus on core strengths and leverage the collective expertise. Collaborative capabilities bring together the knowledge and skills of all appropriate resources, quickly identify product and process issues and enact changes to solve the issue. Companies can remotely review and approve outsourced portions of products and projects by sharing data with their product development organization.
Corrective and Preventive Action (CAPA) System
With the responsibility for delivering a high quality product, many pharmaceutical companies found it necessary to implement additional quality management systems. To achieve compliance with CAPA requirements, companies need an infrastructure to detect existing or potential quality problems. Having CAPA procedures online and tightly integrated with core product information reduces costs by eliminating manual documentation requirements, increasing the effectiveness of root cause analysis and lengthy feedback procedures.
Burden of Systems Validation
Developing validation plans, protocols and executing them can be a time-consuming and expensive task. Often the cost to validate a system is as much or more than the system itself. Enabling service from recognized independent third-party firm to develop a suite of test protocols enables customers to review and approve a validation plan, execute the protocols and document the results thereby reducing the need for expensive consulting engagements.
To maximize profitability and efficient system utilization, the pharmaceutical companies may adopt:
- Accelerate new drug development, introduction and commercialization.
- Allocate R & D resources effectively by improving the ability to eliminate poor compounds early and oversee new drug.
- Collaborate efficiently with partners to accelerate innovation, reduce product and process costs and mitigate noncompliance risks.
- Manage effectively the change to products, packaging components and processes.
- Outsource without losing visibility and control of costs and risks across product lines and partners.
Pharmaceutical companies seek to have a unified view of their entire product development lifecycle with the ability to view and trace every product detail throughout the entire process. By providing a unified view of the products across the organization, industries can finally realize the benefits of cross-functional collaboration where product knowledge is transparent thus facilitating in product governance both internally and externally (compliance with regulatory agencies).
Early awareness of quality events and immediately assessing the impact across the industry will provide the foundation to leverage quality management resulting in improved business performance. An industry solution that enables analysis of drug product value chain including suppliers (materials and equipments) and processes will provide individual lot control and also facilitate the scale-up to commercial drug production volumes.
- Philip Needleman, “From a Twinkle in the Eye to a Blockbuster Drug”, Research-Technology Management, 2001.
- Kevin O’Marah, “Product Lifecycle Management: What’s Real Now”, AMR Research, 2002.
- Venkat Venkatsubramanian, “Prognostic and Diagnostic Monitoring of Complex Systems for Product Lifecycle Management: Challenges and Opportunities”.
- Ioannis Komninos, “Product Lifecycle Management”, Urban and Regional Innovation Research Unit, Aristotle University of Thessaloniki.
- Scope Of Risk Management For The Pharmaceutical Industry
- Operational Excellence and Process Evaluation In Pharmaceutical Manufacturing
- ASTM E2537 – Standard Guide for Application of Continuous Quality Verification
- Top Tips for Pharmaceutical Automation and Validation
- Mr. Umesh S. Patil, pursuing Masters in Pharmacy (Pharmaceutics) from Karnataka Lingayat Education Society’s College of Pharmacy, Vidyanagar, Hubli – 580 031, Karnataka, INDIA. E Mail: firstname.lastname@example.org, Mobile No. +91 96630 82065.
- Mr. Dayanand D. Kore, is graduate in Pharmacy and functioning as Quality Assurance Officer in Encube Ethicals Pvt. Ltd., Madkaim, Phonda, Goa – 403 404, INDIA. E Mail: email@example.com, Mobile No. +91 95031 75372.
Mr. Rajkumar P. Patil
Assistant Manager Production. Is PG in Industrial Chemistry and has a professional 8 years of experience in manufacturing Therapeutic Formulations.
Contact Details –
Om Pharmaceuticals Limited,
12th Mile, Old Madras Road,
Bangalore – 560 049. INDIA.
E Mail: firstname.lastname@example.org / email@example.com
Mobile No. +91 99456 42935.
Shakthi Prakash M R
Manager-Production and Development. Is PG in Chemistry and has got hands of 19 years experience in Pharmaceutical API Production, Formulations (Solid, Liquid dosage forms and Parenterals) and Quality Assurance. Presently engaged in development work of Silk based Biomaterials and Neutraceuticals.
Health Line (P) Ltd.,
IS-21, KHB (IA),
Yelahanka New Town,
Bangalore – 560 106.
E Mail: firstname.lastname@example.org
Mobile No. +91 99801 32898