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2-Day Workshop

FDA/EU GMP Compliance for Quality Control and Contract Laboratories

Istanbul / TURKEY

June 07 & 08, 2011

 

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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

July 28, 2011

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

July 14, 2011 

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

June 30, 2011

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded

 

FDA Compliance for Biopharmaceutical Laboratories

Become familiar with FDA regulations and get tool kits for implementation

June 16, 2011

 

Understanding the New USP Chapters 232/233 for Metal Impurities

With SOPs and Case Studies for Easy Implementation

August 11, 2011

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

Labcompliance News, May 2011

FDA Requests 'Global' Improvements to address Raw Data Issues

Raw data of all regulated records should be maintained and available during inspections. User firms must demonstrate the integrity of raw data and other .records throughout the entire life of the record from generation/acquisition  to disposal. During an inspection of an API manufacturer FDA investigators found that not all raw data were available. The letter reads: "For example, the inspection revealed that your firm lacks raw data of the sample and standard weights used for the HPLC assay of xxx and xxx. The only record available was an Excel spreadsheet with values entered to calculate the final assay results. In addition, some of the HPLC chromatographs of the lots tested were not included in the batch record.- The batch records also lack the dates, amounts, and identity of the person weighing the material."  The FDA expects that such significant compliance problem should not be fixed on a department or site level, but on global corporate level:. "In response to this letter, please detail what global improvements your firm is making to your production and quality systems to address these issues. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-249. The main issue about raw data is knowing what exactly FDA expects to be retained as raw data. To learn everything about definition, maintenance and archiving of raw data, sign up for the audio seminar  "Raw Data in FDA Regulated Environments: FDA/EU compliant recording, maintenance and archiving

EMA Answers Questions Related to the New EU Annex 11

Since the release of the new Version of the EU GMP Annex 11 there are many questions related to implementing Annex 11. The European Medicines Agency (EMA) has included 10 frequently asked questions and answers on its "Q&A: Good Manufacturing Practice (GMP)"  website. Some of the questions are generic, for example, about revalidation of computer systems and validation of spreadsheets. Others are specific to Annex 11, for example related to the implementing the requirement that print-outs should indicated any changes to data since the original entry. Go to the Labcompliance Annex 11 Update Website for more information.

New FDA Guidance for Submission of Summary Bioequivalence Data

The Food and Drug Administration (FDA) issued a new guidance for industry entitled “Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.” The guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and post-approval periods. The guidance can be downloaded from the FDA website.

FDA recommends to hire a Third Party Auditor for detecting (Raw) Data Integrity Problems

Since quite some time FDA inspections focus on the integrity raw data and other records. This became clear during a recent inspection of an API manufacturer. The company had released API product batches but the necessary records, such raw data have not been available during inspections. The letter reads:  "Your Quality Control Unit (QCU) approved the release of four USP batches without data to support that the test for organic volatile impurities (OVI) met release specifications. Should product quality or safety concerns arise in the future, the original records (raw data) pertaining to batches listed in an application may be integral in providing reasonable assurances to the Agency regarding a product and integrity of data submitted to support" The letter also has recommendations what type of raw data should be retained: A firm must maintain all raw data generated during each test, including graphs, charts, and spectra from laboratory instrumentation" Further more the FDA asks for an action plan to ensure data integrity: "Please provide a comprehensive corrective action plan that describes your commitment, procedures, actions, and controls to ensure data integrity" The inspectors considered the violation so bad, that they recommended  hiring an external consultant: "We highly recommend that you hire a third party auditor, with experience in detecting data integrity problems", The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-251.To learn how to ensure availability and integrity of raw data and other records attend the audio seminar  "Raw Data in FDA Regulated environments"

Free FDA Web Seminar on Foreign Inspections

Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010?
On May 17, 2011, the US Food and Drug Administration (FDA) will host a web seminar that answers questions about the agency's foreign inspection program. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA's Global Inspection program. For more information and registration, click here. In case you missed the seminar the slide presentation is still available from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to G-249.  To learn everything about FDA inspections, take a look at the Labcompliance Inspection Package.

USP Updates Draft Chapters 232&233 for Analysis of Metal impurities

USP plans to significantly change the way to do metal analysis in drugs and dietary ingredients. In January 2010 USP had proposed three new chapters with new requirements for limits and recommendations for analysis. In May 2011 USP issued updates to the drug and API related chapters and by 2013 the current chapter <231> will be obsolete. The new chapters will impact about 1000 monographs. It is well known that FDA inspectors require USP standards or equivalent procedures to follow. Therefore pharmaceutical companies are advised to prepare themselves before the chapters will become effective.. The new draft have been published in the May/June issue of the free Pharmacopeial Forum. Attend the audio seminar 'Understanding the New USP Chapters 232/233 for Metal Impurities' to learn everything about new USP requirements and the changes between the first and new draft,

Can Electronic Raw Data be deleted after Printouts?

FDA's 21 CFR Part 211.180(d) requires regulated records to be retained “either as original records or true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records. Examples are chromatograms, inputs, outputs and audit trails generated by computerized laboratory systems. The question has been heavily discussed whether printed HPLC and GC chromatograms and other records are considered 'true copies' of the electronic raw data meaning that e-raw data can be destroyed after print-out. FDA makes a clear statement in one of its CGMP Q&A websites: The printed paper copy of the chromatogram would not be considered a “true copy” of the entire electronic raw data used to create that chromatogram, as required by 21 CFR 211.180(d). In many other examples, e-raw data can be deleted. Attend the Labcompliance Audio Seminar "Raw Data in FDA Regulated Environments" to learn everything about GMP, Annex and Part 11 requirements for raw data, for example, when and when not to delete e-raw data. .

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 "Handling of Laboratory Test Samples". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on June 1, 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

2-Day Workshop

FDA/EU GMP Compliance for Quality Control and Contract Laboratories
Istanbul / TURKEY
June 07 & 08, 2011

Audio Seminar Schedule

  1. FDA Compliance for Biopharmaceutical Laboratories
    Become familiar with FDA regulations and get tool kits for implementation
    June 16, 2011
  2. Validation of Bioanalytical Methods and Procedures
    Conduct and Document for Efficiency and FDA&EMA Compliance
    June 30, 2011
  3. How to Prepare Yourself for FDA's on-going Part 11 Inspection Program
    Learn what the FDA is looking for and how to respond
    July 14, 2011
  4. Periodic Review and Evaluation of Computer Systems
    With strategies and tools for FDA and EU compliance
    July 28, 2011
  5. Understanding the New USP Chapters 232/233 for Metal Impurities
    With SOPs and Case Studies for Easy Implementation
    August 11, 2011

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Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com