Establishing a Remote Audit Process as a CDMO

Adara KurtzBest Practices, Industry

Remote Audits

The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite audits from occurring. As a CDMO, Singota had to pivot to provide clients with transparent and robust compliance audits. This article will dive into the process of establishing a remote audit process and how Singota implemented various changes to acclimate to the new norm.

The Dating Game – Trust & Compatibility in Outsourcing Partnerships

Laura EnglanderBest Practices, Industry

Outsourcing Partnerships

The journey through the clinical trial pipeline is hardly ever direct. Obstacles will present themselves that may or may not have been anticipated. By doing your due diligence in selecting an appropriate outsourcing partner, some of the challenges can be turned into planned objectives as you move closer to (hopefully) positive results in the clinic. Pre-selecting a contract development and manufacturing organization (CDMO) based on not only capabilities but compatibility and trust will help throughout the journey.

Developing a Raw Material Testing Program as a CDMO

Trae CarrollBest Practices, Testing

Raw Material Testing at Singota

Anyone with experience in the pharmaceutical industry knows that the APIs in drug products are tested rigorously for safety and efficacy before reaching the market. Before any raw material can be used for manufacturing, it must meet the requirements outlined in CFR chapter 211.84. Even minor issues with the API or a raw material could compromise the product’s integrity, leading to patient harm or expensive corrective actions such as recalls. Companies that perform drug product manufacturing and raw material testing take this responsibility seriously.

CMO Risk Mitigation: From Lab Scale to Manufacturing Scale

Eric SmartBest Practices, Manufacturing

This series of blog posts on CMO risk mitigation has been focused on the challenge of building an effective working relationship with the contractor a pharmaceutical company chooses to manufacture a drug. This third and final post in this series addresses the problem of bridging the gap from the laboratory to the manufacturing floor.

CMO Risk Mitigation: Managing Process Variables

Eric SmartBest Practices, Manufacturing

In the second of this series of three blog posts, the next objective is to identify Critical Process Parameters (CPPs) – the key variables in a production process that affect Critical Quality Attributes.

In sterile product manufacture, CPPs fall into two main categories: Formulation and Fill/Finish

Understand Your Process: A Key to CMO Risk Mitigation

Eric SmartBest Practices, Manufacturing

This post is the first in a series of three on the subject of CMO risk mitigation. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In these posts we will try to help managers evaluating contract manufacturing to:
-Determine how to work with the CMO to determine critical process parameters;
-Explore strategies to control or eliminate process variables; and
-Learn how to bridge the gap from lab scale to manufacturing scale

Chemical Safety is Designed In

Melanie LewisBest Practices

We began by examining the procedural documentation and training steps a CDMO must take in chemical safety. But some of the most important protective measures can be literally designed and built into to the facilities and equipment.