Quality & compliance

  • Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

    Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?

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  • Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    Understanding Department of Justice Enforcement Policies relating to FDA-Regulated Products

    At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...

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  • What Influences the Compliance Culture at FDA?

    What Influences the Compliance Culture at FDA?

    The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization.  It has hundreds of personnel who are...

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  • FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    FDA & Nitrosamine Impurities – The Proverb of the King with Long Arms

    If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here).  Over time it has developed into the commonly recognized idea...

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  • As PIC/S expansion continues, what does this mean for manufacturers seeking to join?

    As PIC/S expansion continues, what does this mean for manufacturers seeking to join?

    Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...

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  • It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too

    It’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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  • Between Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities

    Between Scylla and Charybdis – FDA Revised Draft Guidance on CGMP Compliance for 503(B) Outsourcing Facilities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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  • Beware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!

    Beware 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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  • FDA Inspections and Cleaning

    FDA 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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  • Can FDA Really Do That? Understanding FDA’s Jurisdiction

    Can 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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  • Critical Differences Between a Form FDA 483 and Warning Letters

    Critical 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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  • Does FDA Consistently Assess Product Quality Risk and Control in Applications?

    Does 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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  • Will FDA Withdraw an Approved Application Over Product Quality Problems?

    Will 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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  • Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t

    Don’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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  • New PIC/S recommendation for evaluating PQS effectiveness in relation to risk-based change management

    New 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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  • Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

    Demystifying 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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  • Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications

    Facilities 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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  • Rescuing Product Approvals from Data Integrity Issues

    Rescuing Product Approvals from Data Integrity Issues

    The pharmaceutical industry is inundated with a plethora of communications about data integrity. Let's look at at one of these situations where applicant holders face these issues successfully.

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  • Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine

    Critical 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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  • New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    New 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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