GxP Lifeline

5 Key Questions About Quality Agreements

Quality agreements between organizations and contract manufacturing organizations (CMO), particularly in pharma, can be crucial to increasing ROI for a manufacturer. But there is a right way and a wrong way to approach quality agreements. Learn some best practices on how to produce more efficient and effective quality agreements.

How Blockchain May Affect Manufacturing

Although it’s a relatively new technology, blockchain has many promising use cases for manufacturers, and new applications of the technology are being introduced at an accelerated pace. Just as digital and cloud technology have caused a major disruption for paper-based enterprises, blockchain has emerged as the next-gen technology disruptor, meaning manufacturers must acknowledge and prepare for the transformation ahead.

Supply Chains Are High Risk For Hardware Hacking

The discovery of a mysterious microchip in servers used in U.S. government offices further blurred the line between fiction and reality. While network and software hacking dominates the cybersecurity spotlight, hardware often goes unnoticed and unprotected. Hence, companies are highly encouraged to give some much-needed attention to supply chain security.

5 Ways to Digitally Transform Your Supply Chain

Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

Call and Response: RFPs and Vendor Proposals

In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.

Need Help With Vendor Selection? Don’t Pick Up the Phone Until You Answer 3 Simple Questions

Vendor selection in pharmaceutical manufacturing and related life sciences sectors is never an easy process. But incorporating comprehensive SOPs that answer three key questions can make for much smoother discussions during the selection process and contract negotiations.

A Risk-Based Approach to Auditing and Qualifying Suppliers and Vendors

For a manufacturer, qualifying vendors and suppliers can be challenging due to varying philosophies and expectations. To avoid ambiguity and uncertainty, manufacturers should have SOPs and policies for interacting with vendors and suppliers. Audits and quality assurance assessments will go smoother with open and clear channels of communication between all parties that will result in improved compliance.

Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 2

A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

Beyond the Mandates: The Business Value of Mass Serialization and Supply Process Visibility, Part 1

A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

Using a QMS to Qualify Your Suppliers

Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

Best Practices for Supplier Evaluation and Rationalization

Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design

Medical device manufacturers must rely on more than their buyers or procurement group to provide supply quality. In order to be successful, companies must implement risk-based design controls in order to minimize risk and maximize benefits to their supply quality process.

What Biotech Startups Need to Do to Slay the Competition

Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

Medtech Startups: How to Survive Cutthroat Competition

In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

Strategic Design of the Supply Chain: Too Little, Too Late for Pharma?

Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.

4 Ways an EQMS Can Help You Improve Supplier Visibility

Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.

5 Areas of Focus When Conducting Supplier Audits

Conducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits. In a recent article for Pharmaceutical Manufacturing, MasterControl Senior Product Manager Terrance Holbrook recommended five actions take to to better conduct onsite supplier audits.

Supplier Qualification: An Important - and Often Neglected - Validation Component

Supply Chain Risk Management: An Ever-Changing Mosaic

We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

Supplier Quality Agreements: Benefits to You and Your Supplier

Note: The views expressed in this article are those of the author and do not necessarily represent those of his/her employer, GxP Lifeline, its editor or MasterControl, Inc."