New Primer on FDA Inspections and Warning Letters

This new 31-page primer entitled "Compliance by Design for Pharmaceutical Quality Control Laboratories" focuses on frequently cited GMP deviations observed during FDA inspections. Several hundred GMP-related Warning Letters and inspection reports were analyzed. Readers can use this information to educate themselves on the current thinking of FDA inspectors as well as on mistakes made by other companies and how to avoid them. Based on information from these citations, certain best practices have also been included that can help design regulatory compliance into quality control laboratories . The primer has been written by Dr. Ludwig Huber and published by Agilent Technologies. The primer is available from the Agilent website as PDF file.  

FDA publishes new Guidance on Current GMP Requirements for Combination Products

This guidance describes and explains the final rule on CGMP requirements for combination products (final rule as codified in 21 CFR part 4) that FDA issued on January 22, 2013. Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule was intended to provide such clarification and specify how compliance with applicable CGMP requirements may be demonstrated. The guidance is available on the FDA website for reading and download.

"Manual Reintegration must follow a documented Procedure", FDA says

When analyzing impurities in drugs and APIs by chromatography it frequently happens that automated peak integration is inaccurate. This may become obvious when looking at the default baseline settings. In this case analyst can use the manual integration feature of chromatographic data systems to correct the deficiencies. In several inspection reports the FDA made it clear that this manual reintegration must follow a company SOP to avoid a situation that reintegration is done for the sole or main purpose to bring out of specification test results into specification.  Examples are: "Your QC personnel perform peak integrations based on analysts’ experience rather than by an approved procedure. A QC operator interviewed during the inspection stated that integrations are performed and re-performed until the chromatographic peaks are “good”, but was unable to provide an explanation for the manner in which integration is performed (W-287)" and " Failure to have a written procedure for manual integration. Your firm made changes to integration parameters for the impurities test without appropriate documentation or justification (W-293)."  These citations are in line with FDA's ongoing focus on data integrity in quality control laboratories. In response to this Labcompliance has developed an Laboratory Data Integrity Package" that has training material and tool kits such was SOPs, checklists and examples to implement, document and  defend data integrity in your laboratory. For example, the package also includes an SOP for manual reintegration of chromatographic peaks.

FDA offers New Guidance Document Search Feature

A new feature on the FDA.gov website allows you to search for guidance documents for all topics across the site from one convenient location.
The site lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

New FDA Guidance on Providing Regulatory Submissions in Electronic Format-Standardized Study Data

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014. For more information, click here.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP "Auditing Analytical Laboratories". To download your free copy, go to the ISO 17025 Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on march 10, 2015). Labcompliance offers more than 170 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here