Impact of cGMP on Supply Chain - Incorporating regulatory requirements into the product life cycle is crucial. - BioPharm International

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Impact of cGMP on Supply Chain
Incorporating regulatory requirements into the product life cycle is crucial.


BioPharm International
Volume 24, Issue 7, pp. 15-17

PLAN AHEAD

The product life cycle for most life-sciences products is long, thereby providing adequate time to develop a detailed strategy for product introduction, manufacturing, and distribution. The ideal time to think about an end-to-end product supply chain is during product research and development (R&D). The ability to ensure quality product delivery to the end user is as much a part of the product as any aspect of development.

Evaluating and selecting suppliers of ingredients and components should be done holistically. Questions to ask include, Is this supplier able to support our needs for increased supply? If not, what alternatives should be considered to ensure a sustainable product—at the detailed bill-of-material level?

Including a supply-chain component in the company's market and commercialization strategy makes it possible to identify areas of risk and concern up front and facilitate any needed remedial action. This process should involve a team approach to ensure that all appropriate participants are included in the planning and implementation stages of development. In addition to scientists and product development specialists who understand the go-to-market strategy, the team should include:
  • Sourcing personnel to identify alternative suppliers for single or sole source materials, while working closely with strategic suppliers to assist them in developing capabilities to meet projected demand.
  • Quality and regulatory compliance personnel to incorporate a quality-by-design approach. Quality progams need to take into account product level quality not only for the components and finished product, but also for material handling equipment, packaging, and cross-contamination concerns. Inclusion of quality assurance and compliance personnel at the R&D stage will enable development of guidelines that can be used throughout the product life cycle.
  • Packaging experts for product protection. They can ensure that storage, handling, and packaging requirements are formalized and incorporated into the product master file and supplier master file. Special handling requirements should be included in SOPs as well as in all product labeling and documentation. Language and literacy requirements across the extended supply network should be taken into account as well.
  • Risk-management, legal and finance experts to identify, qualify, and quantify risk factors. Participation by legal counsel and financial personnel can facilitate the development of a strategy that takes into account global trade legislation, including but not limited to rules of origin, denied parties, the Sarbanes–Oxley Act of 2002, the Foreign Corrupt Practices Act, and foreign currency rates of exchange. Legislation should be incorporated into contractual terms and conditions for suppliers, distributors, and end users.
  • Logistics and trade compliance personnel to consider modes of transportation across origin and destination pairs. Logistics includes many players—be sure to understand the weakest link in the chain and plan for potential problems.

There are additional packaging and distribution considerations to keep in mind when considering the product life cycle and its supply-chain. For example:

  • Consider and provide protective packaging and monitoring devices for products that move through highly variable environments.
  • Define a cold-chain compliance program that takes into account seasonal variations across the possible trade lane configurations.
  • Consider locations where product could be exposed to hazards (e.g., the runway at an airport) during trans-shipment points across the network and implement mitigation strategies and controls.
  • Become informed about product-level literature required for global customs and trade compliance. Product definition and classification has a large impact on rates of duty and tariffs, as well as on foreign customs inspections. Unforseen delays could take weeks or months to resolve, resulting in product degradation and, in some cases, total loss.
  • Understand the impact of shipping and transportation prior to a weekend or during a holiday period and build these factors into guidelines and SOPs.
  • Consider weather, including potential natural disasters, and have contingency plans in place to provide direction to logistics providers to enable them to make alternative arrangements. Cost should not be a reason to put product at risk.

COMMUNICATE, UPDATE, MONITOR

A plan is only as the good as its execution. When a product is approved for manufacturing and commercialization, planning documents should be reviewed to identify any changes and be adjusted accordingly. Detailed SOPs should be communicated to all participants, from suppliers of raw materials and components (and their supply-chain partners) to providers of packaging, storage, and distribution services.

A simple set of dashboard metrics should be developed and agreed upon, providing a framework for ongoing monitoring and control. Regular communication and adjustments will assist in fine-tuning the initial product-level planning and execution framework, thereby facilitating an environment of continuous improvement. The stakes—that is, patient safety—are high and so product planning must be equally thorough and stringent.

Carla Reed is a principal at Tunnell Consulting,
.


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