Chemical Safety Series

Melanie LewisBest Practices, Industry

While finished drug products are intended for eventual human consumption, many of the raw materials and chemicals used to make these products require special safety considerations. Here are some tools to help CDMOs safely manage these important materials:

4 Ways a Client Services Team Can Elevate Your Outsourcing Experience

Kelly BoatmanBest Practices

Client Services is the front door where you and the vendor meet and work together to accomplish your specific service goals. The role of the Client Services team is to fully understand your requirements and then translate those into terms the rest of the organization can act on. If Client Services does their job effectively, they set the stage for achieving the desired results and an exceptional customer experience.

Here are four specific ways that a vendor’s Client Services approach can contribute to the success of your outsourcing experience:

5 Qualifying Questions to Evaluate Solution Providers for Temperature-Controlled Shipping

Travis HudsonBest Practices, Supply Chain Management

Cold Chain Solutions

Life sciences companies with complex warehousing and shipping requirements have a lot of questions – particularly when their requirements include temperature-controlled shipping. For a potential solution provider, it’s not enough just to have a refrigerated warehouse and trucks. The product may not even need refrigeration – it may need to be kept at or near room temperature. How can the pharmaceutical company identify a logistics vendor with the right competency? Here are five basic questions a pharmaceutical company operations manager can use to evaluate a vendor’s qualifications to provide a high-value solution:

The ABCs of Pharmaceutical Labeling

Tammy SummervilleBest Practices, Production

Pharmaceutical Labeling

What’s one of the first lessons one learns as a child? The alphabet, of course! Remember those blocks with the letters on the sides? The ABCs are so important because they are the foundation of our language and communication. Labeling pharmaceutical products also has important Foundational Blocks used to build success. Here are the ABCs of labeling:

5 Keys to Avoid Drug Development Delays When Using CROs

Ken ChomistekBest Practices, Development

CRO

Dealing with contract research organizations (CROs) can be a nightmare for some drug developers. You may be a start-up pharmaceutical company with one molecule and you now need to hand over your baby to a cold and unfamiliar group of people who haven’t been nurturing this project for years. Maybe you are in academia and this is your first big chance to spin off your own company and you need a partner to help you with development. Whoever you are and whatever your situation; it can be daunting to select and partner with a CRO. Here are five key factors to keep in mind when trying to troubleshoot drug development delays by selecting the right CRO:

3 Steps to Determine Need for Performing a Shipping Lane Qualification

Travis HudsonBest Practices, Supply Chain Management

Risk Assesment

Materials moving through the Pharmaceutical Supply Chain encounter many threats which could negatively impact product integrity. In order to adequately determine the level of control required to ensure safe transport of products, one must perform various risk assessments. Performing a risk assessment will provide visibility into the different risk factors and allow for proper resource allocation to mitigate those risks based on their potential impact. Based on the findings of these risk assessments, you can determine if the need for performing a full shipping lane qualification is recommended.

Sampling and Dispensing: When to Request Each

Carl RushBest Practices, Supply Chain Management

Sampling and Dispensing

Do you know which type of aliquot of material to request when needing a portion of a batch or lot? Sampling and dispensing are two services provided to help release materials for use, as well as meet manufacturing goals. These materials include APIs (active ingredient in pharmaceutical products) and excipients (inactive substance, filler, bulking agent). To see if you know when to use sampling versus dispensing, test yourself with the following questions:

3 Steps to Strengthen Your Supply Chain Partnerships

Travis HudsonBest Practices, Supply Chain Management

Supply Chain Management

Regardless of where your organization operates in the pharmaceutical supply chain, chances are that your successful outcomes are a product of (1) internal expertise and (2) beneficial partnerships.

Synergies amongst these partnerships are a potential reality. But, if you’re struggling to achieve legitimate value, take advantage of this 3-step process to strengthen your supply chain partnerships:

5 Fixable Processes that Affect Pharmaceutical Shipping Metrics

Travis HudsonBest Practices, Supply Chain Management

While many industries have few repercussions for an occasional late shipment (minus an agitated customer or two), the pharmaceutical industry isn’t one of these. Late arrivals in the pharmaceutical realm can point to temperature excursions, product degradation, or even the loss of a life if an urgent treatment has been delayed.

Obviously, many things are out of your control once your product is in transit. So, analyze (and then fix) the processes that are in your control to improve your metrics. To get you started, here are five areas that may be worth evaluation:

5 Elements of a Successful Analytical Method Transfer

Tammy Thompson-MadsenBest Practices, Development

No matter where your product is in the pharmaceutical pipeline, from early formulation development to commercial production, analytical procedures will be used to ensure the identity, quality, purity and potency of the drug substance or product. As a product moves from research and development to manufacturing, it may be necessary to order an analytical method transfer of your established (validated) procedure from one laboratory to another to achieve product realization. Here are 5 elements to ensure success: