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

 

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

Recorded, available with all reference material at any time

 

Stability Testing in Pharmaceutical and API Industry
Learn how to design, conduct and document studies for FDA and ICH requirements

Recorded, available with all reference material at any time

 

Validation of Analytical Methods and Procedures

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

Recorded, available with all reference material at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

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

Recorded, available with all reference material at any time

 

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

February 25, 2010

 

How to Efficiently Get ISO 17025 Accreditation

Step-by-step from the idea to cost-effective implementation
Recorded, available with all reference material at any time

 

Documentation for FDA and ISO 17025 Compliance
Step-by-step Instructions with Sample Documents
Recorded, available with all reference material at any time

 

Qualification and Calibration of Stability Chambers
Learn how to select, conduct and document the right test parameters and conditions
 Recorded, available with all reference material at any time

 

New  release on
August 25, 2009 

with 200 + eirs/483sb / warning letters

 

 

Labcompliance News, December 2009

FDA Releases New Revision of ICH Guidance Q8

The US Food and Drug Administration just released a new revision of ICH Q8 'Pharmaceutical Development' that was published in May 2006. In June 2009, the Q8 parent ICH guidance was revised to add an annex, which provides further clarification of the key concepts outlined in the May 2006 guidance and describes the principles of quality by design (QbD). The Guidance can be downloaded from the FDA website

50 New Documents in the Labcompliance Usersclub

We have added 50 new documents to the Labcompliance Usersclub. They include 12 new SOPs, 11 checklists/ templates/examples, FDA presentations and guidance documents and FDA warning letters/483's related to GMP/GLP or GCP. There is a video clip with an update on Part 11. To see the new titles, click here. User club members can instantly download the new additions. To see the list and ordering the users club, click here, and scroll down to 'new additions'. With these additions, the Usersclub has more than 500 documents ready for download. 

The First 'Closeout Letter' Posted on the FDA Website

In August FDA commissioner Margaret A. Hamburg, M.D, had announced the development and implementation of a formal warning letter “close-out” process. With this the agency determines that a firm has fully corrected violations raised in a warning letter and post this information on the FDA Web site. Now the FDA has posted the first letter. The letter states: "The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated October 08, 2009. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections"

Increasing FDA Focus on Computer Validation

While FDA was quiet about software and computer system validation between 2002 and 2006 this has changed significantly since 2006. Software and computer system validation has become an inspection focus for pharmaceutical, API and device industry. Deviations have been cited related to all steps of computer validation from writing specification and risk assessment to IQ/OQ/PQ, revalidation, reporting and change control. To see examples, click here.  To prepare your organization for FDA inspections, and to avoid FDA warning letters related to computer validation, attend the upcoming Audio seminar: Computer System Validation: Step-by-Step, with Case Studies and IQ, OQ, PQ protocols for easy implementation

FDA Releases Final Guidance on Residual Solvent Analysis

The guidance replaces the draft version from August 2008. With the new guidance FDA allows using test data as an alternative to tests performed by the drug manufacturers: "FDA can accept residual solvent test data on components from tests performed by the drug product manufacturer or the manufacturer may provide test data or, if applicable, appropriate statements obtained from properly qualified suppliers as described in 21 CFR 211.84(d)(2). For example, reports of analysis can be accepted from a properly qualified  supplier of a drug product component and will be used by the drug product manufacturer to determine whether the finished drug product complies with the General Chapter <467> defined limits." The guidance is available on the FDA Website. To learn everything about residual solvents analysis according to the new FDA Guidance and USP <467> attend the Labcompliance audio seminar and receive updated best practice documents for easy implementation.

FDA Warns Drug Manufacturer for not including Dissolution in the Stability Program

A drug manufacturer was cited in an FDA Warning Letter for not including dissolution and controlled-release drug product specifications in the stability program. The letter states: The written stability program for drug products does not include reliable, meaningful and specific test methods which include dissolution testing and the establishment of controlled-release drug product dissolution specifications for any of the marketed tannate drug products to ensure finished drug product performance at expiry, as required by 21 CFR 211.166(a)(3). In addition the company failed detect all active ingredients in the finished product. The the warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 225). To learn everything about an FDA complaint stability program, attend the upcoming Audio seminar: Stability Testing for FDA and ICH compliance..

GHTF Publishes Guidance on Corrective and Preventive Actions

The Global Harmonization Taskforce has published a draft guidance on  corrective action and preventive action and related QMS processes. GHTF is a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The guidance is intended for medical device manufacturers and regulatory authorities but the concepts and recommendations are also useful for other industries.. The 25 page guidance can be downloaded from the GHTF website as word and PDF document.

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: Subcontracting of Testing and Calibration. 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 January 20, 2010). 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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