Category: Other
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GMP Term of the Week – Drug Substance/Drug Product Container Labeling
GMP Term of the Week – Drug Substance/Drug Production Production Labels By: Greg Weilersbacher, EQC Founder & President | 5-min read Drug Substance/Drug Product Production Labels Drug Substance / Drug Product Production Labels – GMP labels applied to drug substance or clinically packaged drug product containers that identify the material name, lot/batch number, retest/expiry, storage…
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5 Best Practices for Maximizing the Benefits of a Supplier Audit
By: Greg Weilersbacher, EQC Founder & President | 10-min read Every business nowadays uses some form of outsourcing. Recognizing that you can’t handle everything on your own is a sobering realization. Allocating funds to create and maintain some activities in-house while opting to contract higher-cost operations to qualified providers who already possess the knowledge and…
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Evaluating How Your CDMO Operations Will Be Affected By New Equipment
By: Greg Weilersbacher, EQC Founder & President | 10-min read New equipment is exciting for everyone, not just engineers and production workers. Investing in new equipment allows a contract development and manufacturing organization (CDMO) to expand its service offerings and increase its output, both of which are useful for creating new marketing content to bring…
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How Virtual Businesses Can Leverage Strategic Outsourcing
By: Greg Weilersbacher, EQC Founder & President | 8-min read Navigating Outsourced Solutions & Providers Various obstacles exist for a virtual business trying to advance a drug candidate into commercial development. The lack of skills and expertise are two of the most challenging obstacles a virtual business needs to overcome since no one is an…
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Sponsor Selection Criteria for CDMOs – Part 1 of 3
By: Greg Weilersbacher, EQC Founder & President | 7-min read Facility Design What Pharmaceutical Organizations Need to Know This is the first article of a three-part series that discusses aspects of the production facility and laboratory architecture that improve the sponsor experience, safeguard the product from cross-contamination, and guarantee that the product will be made…
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Sponsor Selection Criteria for CDMOs – Part 2 of 3
By: Greg Weilersbacher, EQC Founder & President | 6-min read How Well-Versed Are You in the Equipment of Your CDMO? How Well-Versed Should You Be? As was covered in the first part of this series, sponsors often have specific requirements they want to be met by contract development and manufacturing organizations (CDMOs). In this second part,…
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Sponsor Selection Criteria for CDMOs – Part 3 of 3
By: Greg Weilersbacher, EQC Founder & President | 7-min read Improving the Sponsor Experience Audit Transparency for Sponsors In the first two articles of this series, we discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs), as well as sponsor requirements for equipment redundancy, immediate…
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GMP Production Facilities Equipment Change Control – Part 1 of 2
By: Greg Weilersbacher, EQC Founder & President | 8-min read Getting Started This is the first of two articles that will lay out a comprehensive framework that businesses can use to create effective equipment change control processes that adhere to relevant regulations. According to Annex 15 of the EU GMP Guidelines, “change control” is defined…
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GMP Production Facilities Equipment Change Control – Part 2 of 2
By: Greg Weilersbacher, EQC Founder & President | 8-min read Confirming That the System Works Part one of this two-part series introduced the six main stages involved in equipment change control and addressed the first two of those stages in detail: Determining equipment utility requirements Conducting a pre-installation assessment, utility evaluation, and addressing problems. Emphasis…