Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars



 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

Recorded

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations

Recorded

Simplify Validation and Qualification with ASTM E2500
Cost Effective Alternative for Equipment Qualification and System Validation

Recorded

Analysis of Metal Impurities According to New USP Chapters

Understanding the Proposed USP Chapters <232>, <233> and <2232> for Elemental Impurities

Recorded

How to Efficiently Get ISO 17025 Accreditation

Step-by-step from the idea to cost-effective implementation

Recorded

Documentation for FDA and ISO 17025 Compliance
Step-by-step Instructions with Sample Documents

 Recorded

 

Qualification and Calibration of Stability Chambers
Learn how to select, conduct and document the right test parameters and conditions
Recorded

 

New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters

 

 

Labcompliance News, January 2010

USP Proposes three new Chapters for Heavy Metal Impurity Analysis

USP takes a new approach for Heavy Metal impurities, now called Elemental Impurities. The proposals for three new chapters and two stimuli articles are being published in the
 January-February issue of Pharmacopeial Forum (PF 36(1).  Chapter <232> specifies the compounds and limits, chapter <233> measurement procedures and chapter <2232> is for elemental contaminations in Dietary Supplements. The stimuli papers provide more detailed information and discuss comments and responses from the advisory panel. For more information, visit the USP website. Labcompliance has scheduled an audio seminar. This provides a good overview with background information, methodologies, a comparison with EU requirements and approaches to implement the proposals.

A Vendor's Statement is not Enough Evidence for Software Validation

Still today some vendors advertize software as being validated, and companies erroneously believe they don't have to validate the software at the user's site. This was clarified during an FDA inspection of a software used in a human tissue bank. When the investigator asked for validation documents the company only showed her a letter from the vendor indicating that the software was validated which was the reason why the company purchased this product. An observation in the 483 simply stated that the performance of computer software has not been verified. More information on what went wrong was disclosed in the associated Establishment Inspection Report (EIR): "The firm must verify the performance of the computer software for the intended use and document these activities". For a full article, click here. The 483, the EIR and the company response can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-226 for the 483  and to W-191 for the EIR and the company response. Get step-by-step advice on software and computer system validation during the Labcompliance audio seminar Computer System validation: Step-by-Step

New FDA Guidance on Assay Development for Immunogenicity Testing

The Food and Drug Administration announced in a Federal Register notice the availability of a draft guidance for industry entitled ‘‘Assay Development for Immunogenicity Testing of Therapeutic Proteins.’’ The draft guidance provides recommendations to facilitate industry’s development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials. The guide can be downloaded from the FDA website.

FDA  'Advice' on Validation and Use of Excel®

Excel is frequently used in laboratories, offices and manufacturing as sophisticated  calculator.  Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. The new Annex 11 for EU GMP's and GAMP®5 also include chapters on Spreadsheets. To learn everything about FDA's and other regulatory expectations and enforcement practices for using Excel click here.

Updated FDA Guidance for Non-Clinical Safety Studies

The FDA has released a new revision of an earlier ICH guide: "Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals" The purpose of the document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions. This guide applies to the situations usually encountered during the development of pharmaceuticals and should be viewed as general guidance for drug development. The guide can be downloaded from the FDA website.

Not Putting Finished Drugs on Accelerated Stability Studies Draws FDA Warning

A pharmaceutical manufacturer only had put development batches on accelerated and long-term room temperature stability studies to justify the assignment of a tentative expiration dating period but not finished products. And there was no documentation or data to support or demonstrate equivalence between development and commercial batches with regards to equipment, components, and manufacturing processes. The manufacturer was recommended to provide a time frame for completion of the corrective action plans, and a more detailed stability commitment. In addition the FDA found other deviations: inadequate Drug production and control records not reviewed by QCU, complaints not reviewed during annual product review and, failures to clean, maintain and sanitize equipment. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-227.  Learn more about FDA enforcement in the Labcompliance audio seminar and how to plan, conduct and document stability studies to be in line with ICH and FDA requirements.

New Audio Seminars in 2010 - Schedule Available

The popular Labcompliance audio seminar series will go on in 2010 with more offerings. in Q1 we offer a total of  nine seminars with new topics such as stability testing, ASTM E2500 for equipment verification, and USP's new approach for heavy metal analysis. The list below shows all seminars to be delivered in Q1. To see the complete list with over 100 recorded seminars, click here, By the way, in the first seminar this year we had one company attending with 60 employees from all departments to learn everything about Validation of Computer Systems: Step-by-Step. To see the content and the attendees` feedback, 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: Document Management and Control. 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 February 20, 2010). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule for Q1/2010

 

New or Updated Sites

Click here to tell others in your company about compliance news