Regulatory Sciences
CMC Expectations During Drug Substance Transfer from Ex-US Manufacturers
Regulatory Drivers for US-based API Manufacturers Recent shifts in US tariff policies have introduced new pressure points in the global pharmaceutical supply chain, particularly for manufacturers...
Quality & Compliance
Dealing with API and Excipients in a Time of Tariffs
The US Government recently modified its policy to utilize tariffs to support the US economy. Pharmaceutical tariffs have been forecasted, causing many global organizations to investigate the...
Quality & Compliance
Tech Transfer Readiness: Big Responsibility, Greater Reward
So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech...
Quality & Compliance
Technology Transfer Projects: Assessing Need and Readiness
So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing...
Quality & Compliance
Adapting Technology Transfer Strategies in Pharmaceutical Manufacturing Amidst New Tariff Regulations
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy causing many global organizations to investigate the consequences of the tariffs on their...
Quality & Compliance
Navigating the Impact of New Tariffs: Strategies for Success Amidst Recent Trade Policy Changes
The US Government recently modified their policy to utilize tariffs to in an effort to support the US economy. Significant changes have been announced causing many global organizations to investigate...
12 Critical Questions and Answers for a Successful Tech Transfer
12 Critical Questions and Answers for a Successful Tech Transfer Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time,...
Analytical Method Transfer Checklist
As you plan for an upcoming Tech Transfer, have you considered if you are appropriately prepared to conduct an analytical method transfer? With the simple analytical method transfer checklist...
Is Your Technical Transfer Process Aligned with Process Validation Requirements?
There has been a lot of discussion recently concerning process validation and technology transfer, including utilizing virtual technology transfers to quickly move products through the development...
How critical is the Technology Transfer phase of new drug development?
During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...
GAMP® 5 Concept 2 – System Life Cycle
So far in our series on GAMP 5 we’ve provided a high level overview of the five major GAMP concepts, and a more in depth discussion of Concept 1, Process Knowledge and Understanding. In this...
GAMP® 5 Concept – Process Understanding
In my previous blog I re-visited key GAMP® 5 concepts as they relate to establishing a compliant system validation methodology. My next few blogs will focus on each of these concepts in more detail....
Post-Validation: Gate Nine of the Nine Gate Transfer Process
As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...
GAMP® 5 Basis for Quality System Compliance
Next week I’ll be in San Francisco conducting an ISPE training class on Risk Based Approach to GxP Process Control Systems. Attendees will include employees from a variety of regulated life cycle...
Process Validation: Gate Eight of the Nine Gate Transfer Process
Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...
Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process
Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...