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FDA Compliant Transfer of Analytical Methods

Prepare your Lab for the NEW USP General Chapter

Recorded, available with all reference material at any time

 

Handling Out-of-Specification Tests Results and Failure Investigations
With case studies to avoid and respond to FDA 483's and warning letters

Recorded, available with all reference material at any time

 

FDA Compliant HPLC Qualification and Performance Testing
Learn how to select, conduct and document the right tests in the right sequence

Recorded, available with all reference material at any time

 

How to Efficiently Build a GLP Laboratory
Step-by-step from design to cost-effective implementation

Recorded, available with all reference material at any time

New  release on
Sept 20, 2009 

with 46 SOPs

Labcompliance News, October 2009

New USP General Chapter for Metal Impurity Analysis under Development

The United States Pharmacopeia is in the process to develop a new general chapter <231> on metal analysis. Barbara Zink of USP told the audience of a joint USP/Agilent seminar in Hyderabad/India details on the process and current status. A milestone was a workshop in April this year with representatives from industry, agencies and other Pharmacopeias. The purpose of the Workshop was discuss new approaches for metal impurities in pharmaceuticals and dietary supplements, including methodologies and toxicological limits. One of the recommendations was to focus on the top four metal impurities: inorganic arsenic, cadmium, lead and methyl mercury. For an update, click here.

Averaging of OOS Test Results Draws FDA Warning Letter

An API manufacturer's procedure allowed to average in-specification tests results with out-of-specification (OOS) results. This practice resulted in an FDA warning letter. The letter states: The API batches were released based on reportable assay results obtained from the average of two independent sample results. One of the sample results was out-of-specification (ODS) while a second result was within specification. The averaged passing reportable assay result was compared against the established specifications, and the batches were released to the marketplace". According to the FDA this practice did not conform with FDA guidance: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Products,  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 220).  To learn everything about FDA compliant handling of OOS test results and when averaging of results is allowed,  attend the upcoming audio seminar.

FDA Issues Guidance on Risk Evaluation and Mitigation Strategies (REMS)

On Sept 30, The U.S. Food and Drug Administration announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics. The guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications” provides FDA’s current thinking on the format and content that industry should use for submissions of proposed REMS, it  describes each potential element and includes preliminary information on the content of assessments and proposed modifications of approved REMS- To see the press release, click here. To download the guidance, click here.

Missing Evaluation of HPLC Detector Noise/drift Cited in FDA Warning Letter

FDA warning letters get more and more specific. While neither FDA regulations nor guidance documents specify what HPLC parameters should be tested FDA inspectors start to cite missing or incomplete testing as deviations in warning letters.  Inspectors quote 21 CFR § 211.160(b)(4) with a requirement to conduct adequate calibration of instruments. Example citations are: "Your firm failed to conduct injector and detector performance testing for the xxx system", "For example, no HPLC injector and detector testing for linearity, accuracy, and precision were conducted, such as evaluation of detector for noise/drift; and carryover testing"  This warning is a clear proof of FDA's much tougher policy. It also is a clear statement that HPLC's require full performance testing (OQ) and that system suitability is not enough.  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 221).  To learn everything about FDA expectations for HPLC initial and on-going testing, attend the upcoming audio seminar

New FDA Guidance for Microbiological Data for Antibacterial Drug Products

The FDA has published a new Industry Guidance on "Development, Analysis, and Presentation of Microbiological Data for Systemic Antibacterial Drug Products.". The purpose of this guidance is to inform industry of the FDA’s current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product.  Recommendations i cover three major areas: (1) conducting general nonclinical studies; (2) conducting animal and human studies and clinical trials; and (3) establishing and updating in vitro susceptibility test methods, quality control parameters, and interpretive criteria. The guidance can be downloaded from the FDA website.

FDA's Current Inspection Focus is on OOS, Failure Investigations and CAPA

FDA's focuses inspections on how companies follow up with OOS situations. This once again became obvious in a warning letter to an API manufacturer. The letter reads as violation: "Failure of your investigations of out-of-specification results to determine if corrections or preventive actions are needed. Your firm failed to continue its investigation of the OOS results outside of the laboratory in order to determine the cause of the results." Furthermore the FDA letter recommends "Any OOS result obtained should be investigated and documented according to a procedure. This procedure should include analysis of the data, assessment of the extent and cause of the problem, allocation of the tasks for corrective actions, and conclusions." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 209).  To learn everything about FDA compliant handling of failure investigations, Out-of-specification and Out-of-trend test results, attend the upcoming audio seminar 

Warning Letter: OOL/OOS Results Generated by a Contract Lab not Investigated

During an inspection  of a pharmaceutical manufacturer the FDA found several several violations of cGMP regulations related to inadequate handling of out-of-specifications (OOS), out-of-limit (OOL) situations and failure investigations. Tests were conducted in contract laboratory. The letter made stated that the sponsor company has to make sure that Ouf-of-Limit (OOL) and Out-of-Specification (OOS) results obtained in a contract laboratory should be adequately investigated, for example, the letter states: "Although results above your alert limits may be an indication of an ongoing uncorrected problem, no investigation was conducted to identify a potential root cause of the problem". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 219).  To learn everything about FDA compliant handling of failure investigations, Out-of-specification and Out-of-trend test results, attend the upcoming audio seminar

Labcompliance Network Compliance Package Available as Download

The popular Network Quality&Compliance Package is now available as download version, in addition to traditional CD/Binder Version. The package includes 24 SOPs, a primer and a project plan It also comes with 13 examples/checklists, two audio seminars and two years free online updates. FDA and international agencies require network infrastructure to be formally qualified and tested. The package helps to develop strategies for network qualification and it has the tools for trouble free implementation. For details on content and ordering, 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: Reserve samples in Laboratories. To download your free copy, go to the Computer System Validation Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on October 30, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

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