Category: Other
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Five Questions to Ask when Prioritizing GMP Audits
Five Questions to Ask when Prioritizing GMP Audits By: Greg Weilersbacher, EQC Founder & President | 5-min read For sponsors outsourcing all GMP activities it may seem as though all of your GMP suppliers are critical. However, not every supplier performs the same service, manufactures the same type of product, or provides services at the…
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De-Bunking the Myth – “21 CFR Part 11 is more of a Suggestion than a Requirement.”
De-Bunking the Myth – “21 CFR Part 11 is more of a Suggestion than a Requirement.” By: Greg Weilersbacher, EQC Founder & President | 5-min read Eastlake Quality Consulting has heard this statement (or variations of it) so many times we’ve lost count. Its often said by management personnel supervising drug substance and drug product…
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De-Bunking the Myth – “All Contract Manufacturers Have Great Customer Service”
De-Bunking the Myth: All Contract Manufacturers Have Great Customer Service By: Greg Weilersbacher, EQC Founder & President | 5-min read Choosing a CMO – Selection of a Contract Manufacturing Organization (CMO) to manufacturing your drug substance, drug product or clinical packaged product can be a challenging task. A sponsor’s criteria typically include the CMO’s technical…
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GMP Term of the Week – Performed by / Verified By
GMP Term of the Week – Performed By / Verified By By: Greg Weilersbacher, EQC Founder & President | 3-min read Performed By / Verified By – A GMP operation in which one person performs a step in a production batch record and the execution of that step is observed and verified in real-time by…
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De-Bunking the Myth – “Paper records are our only official GxP documents.”
De-Bunking the Myth – “Paper records are our only official GxP documents.” By: Greg Weilersbacher, EQC Founder & President | 2-min read The claim that a company’s paper documentation of GxP activities is their only official records is pervasive and continues to be entrenched in the pharmaceutical and biotech industries. In fact, the practice rears…
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GMP Term of the Week – Drug Potency
GMP Term of the Week – Drug Potency By: Greg Weilersbacher, EQC Founder & President | 3-min read Drug Potency – The formulated active strength of a drug product (e.g., 25mg, 50mg) that is designed to be efficacious in treating an illness or other medical condition. Why it Matters – Drug products must be formulated…
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GMP Term of the Week – Fraudulent BSE/TSE Certificates
GMP Term of the Week – Fraudulent BSE/TSE Certificates By: Greg Weilersbacher, EQC Founder & President | 3-min read Bovine Spongiform encephalopathies (BSE) – A disease in cattle belonging to a group of fatal neurodegenerative diseases affecting humans and animals called transmissible spongiform encephalopathies (TSEs) caused by an abnormal form of a cell protein called…
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GMP Term of the Week – Line Clearance
GMP Term of the Week – Line Clearance By: Greg Weilersbacher, EQC Founder & President | 5-min read Line Clearance – A systematic assessment performed prior to the start of a GMP production that confirms all raw materials, containers/closures are released and within their retest/expiry, equipment is clean and within calibration expiry, and room cleaning,…
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GMP Term of the Week – As-Built Drawings
GMP Term of the Week – As-Built Drawings By: Greg Weilersbacher, EQC Founder & President | 3-min read As-Built Drawings – A set of architectural drawings that are marked-up by a contractor building a GMP production or testing facility to show how the facility was actually built versus the way it was originally designed. Why…
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GMP Term of the Week – Cleanroom Pressure Differentials
GMP Word of the Week – Cleanroom Pressure Differentials By: Greg Weilersbacher, EQC Founder & President | 5-min read Differential Pressure – A dissimilarity in air pressure between one cleanroom and adjacent cleanrooms, hallways, air locks, and pass-throughs created by a difference in air velocity/air volume and mechanical means of limiting air transfer from one…