Technical Reference Document Issued for Quality Metrics

The FDA today released a technical reference document entitled, “Quality Metrics Technical Conformance Guide for the Implementation of the Draft FDA Guidance for Industry on Requests for Quality Metrics.”

This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported.  Remember that,

Is FDA Starting to Think (Again) About Cloud Computing?

In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.

Data Integrity Guidance Issues – Sounds Like a Softer FDA Song

While the number of data integrity (DI) findings have increased over the last few years, as evidenced by citations in a number of Warning Letters, the FDA stance on DI seems to have mellowed since the generic drug scandal of the late 1980s.  The FDA guidance document (here)   walks firms through their responsibilities in assuring that cGMP requirements relative to assurance of the accuracy,

Promoting and Protecting Data Integrity

The integrity of data used to ensure the quality of drugs is paramount to a drug’s safety and efficacy and can have a great impact on public health. The topic of “Protecting and Promoting Data Integrity” was presented by Kathleen Culver from FDA (Field Investigator and Drug Preapproval Manager, FDA Cincinnati District), Tracy Moore (Senior GMDP Inspector and GMDP Operations Manager, MHRA), and Paul Vogel (Chairman, Lachman Consultant Services, Inc.) at the recent PharmaLink Conference, which was co-sponsored by Xavier Health and the FDA, held on March 16-17, 2016 in Cincinnati, Ohio.

Developments in Continuing Process Verification

The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.

Who Are These Guys?  OGD Updates Part of Its Organizational Chart

The Office of Generic Drugs (OGD) has updated its organization chart, but trying to figure out who is who in most of the OGD Office and Divisions remains a bit mysterious. Try to find the titles and position of many of the OGD staff and you kind of run into an electronic wall. Even if you know their names, their position and location within OGD, they are not easily discernible.

FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here).  The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products.  The document provides guidance for NDA holders (for new products or changes to existing products) and for ANDA applicants. 

FDA Clarifies Issues Regarding Outsourcing Pharmacies

The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.”  Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food,

It’s Official – A New Guidance Document for Analytical Method Validations

 

Last week, the FDA released a Guidance entitled Analytical Procedures and Method Validations for Drugs and Biologics (here)  which replaces the 2000 Draft Guidance document Analytical Procedures and Method Validation” and the 1987 Guidance document “Guidelines for Submitting Samples and Analytical Data for Methods Validation”.

Quality Metrics Draft Guidance Issues

Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.” The document outlines the FDA’s thinking on the use of quality metrics data “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”