Quality & compliance
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Learn MoreIt’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too
In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...
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Learn MoreBetween Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities
In January 2020 the Food and Drug Administration (FDA or “agency”) published the revised draft guidance Current Good Manufacturing Practice – Guidance for Human Drug Compounding Outsourcing...
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Learn MoreBeware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!
Donor Eligibility (DE) determination is a central aspect of how FDA and other regulatory authorities ensure that a product from a single allogeneic donor has acceptable very low risk of...
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Learn MoreFDA Inspections and Cleaning
Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection. Often cleaning validation studies are extensively...
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Learn MoreCan FDA Really Do That? Understanding FDA’s Jurisdiction
On August 29, 2019 the US FDA sent a Warning Letter to Shanghai Institute of Pharmaceutical Industry (SIPI) (see the Warning Letter). The FDA charged the firm with refusing a pre-announced...
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Learn MoreCritical Differences Between a Form FDA 483 and Warning Letters
There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...
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Learn MoreDoes FDA Consistently Assess Product Quality Risk and Control in Applications?
Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...
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Learn MoreWill FDA Withdraw an Approved Application Over Product Quality Problems?
There have been some recent headlines where the acting FDA Commissioner and other senior agency officials have stated that the FDA will consider the use of its full authorities to take...
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Learn MoreDon’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t
In a recent blog post, I wrote about how manufacturers can overcome data integrity problems that potentially imperil an application’s approval and commercializing a product. Sometimes...
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Learn MoreNew PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management
On November 28, 2019 the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a draft Recommendation for Participating Authorities, providing practical guidance for GMP...
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Learn MoreDemystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...
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Learn MoreFacilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
FDA released its Guidance for Industry (GFI) regarding Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers on October 22, 2019. ...
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Learn MoreRescuing Product Approvals from Data Integrity Issues
The pharmaceutical industry is inundated with a plethora of communications about data integrity. Most of those are focused on the downside – operational snags, negative inspection findings,...
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Learn MoreCritical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine
If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...
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Learn MoreNew Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers
With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...
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Learn MoreTips from FDA – Put Design of Experiments to Use in Drug Applications
One of the benefits to having worked at FDA was the opportunity to gain exposure to how a wide variety of manufacturers perform product development and manufacturing and how they present...
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View NowCase Study Achieving Product Endorsement_FDA Warning Letter
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View NowCase Study_Regulatory Compliance Services-NDA Approval
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View NowCase Study Data Entry and Data Cleansing
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View NowCase Study data integrity warning letter
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