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50 New Usersclub Additions

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

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

 

Cost Effective Validation of Laboratory Computer Systems

With industry proven examples for all validation steps

Recorded, available at any time

 

Using Electronic and Digital Signatures in Regulated Environments

Comply with FDA Part 11 and with international regulations and guidelines

November 15, 2012

 

Validation of Analytical Methods for GLP and Clinical Studies

Learn how to design, prepare, conduct and document for FDA compliance

November 29, 2012

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

December 13, 2012

 

Understanding and Implementing the New EU Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

December 20, 2012

 

Calibration and

Calibration and Qualification of Stability Chambers

With 10 examples/templates for all validation steps

Recorded

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

August 30, 2012

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
September 27, 2012

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

Recorded
Available at any time

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

Recorded, available at any time

 

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

Learn what the FDA is looking for and how to respond

Recorded

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

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, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available at any time

 

 

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

 

 

 

 

Labcompliance News October 2012

New  FDA Guidance for ANDA Stability Testing

This 5-page guidance recommends that abbreviated new drug applications (ANDAs) submitted pursuant to section 505(j) of the Federal Food, Drug and Cosmetic Act, and the drug master files (DMFs) that support ANDAs, follow the stability recommendations provided in International Conference on Harmonisation (ICH) stability guidances. Although the ICH stability guidances were developed by ICH to provide guidance on the information that should be provided in new drug applications to ensure the stability of new drug substances and drug products, we believe the recommendations should be applied to ANDAs as well. To view and download the guideline, click here. Stability chambers used for any regulated stability testing should be qualified. To learn everything about qualification of stability chambers attend the new Labcompliance audio seminar "Qualification and Calibration of Stability Chambers."

EMA answers Questions related to Specification Limits of Genotoxic Impurities

Questions are answered on the EMA website: Quality of medicines questions and answers. The discussion is a follow-up to questions related to the EMA guide from 2007:  Limits of Genotoxic Impurities and to an earlier Q&A session from 2010. One of the key questions is: What is a reasonable policy for setting specifications for potentially genotoxic impurities which are theoretical or actual impurities in a drug substance manufacturing process. Answers are given using three practical examples. To read the Q&As click here. Scroll down to "Impurities - Harmonisation of policies on setting specifications for potentially genotoxic impurities"

PIC/S Adopts EU GMP Annex 11 as PIC/S Annex

During the recent PIC/S events in Kiev, Ukraine, 30 September - 5 October 2012, members reviewed the revision of several PIC/S GMP Guides and Annexes based on the revisions of the EU GMP Guides and Annexes. Amongst others the EU GMP Annex 11 has been adopted. This is no surprise because also the previous Annex 11 from 1993 had been adopted. Since 2011 US FDA has been a member of PIC/S. To a large extent Annex 11 is complementary to Part 11 as a quality management system for computer systems with a broader scope than Part 11 which is focusing on e-records/signature management. So most likely FDA inspectors will use Annex 11 as guidance during inspections. Some of the Annex 11 requirements are already indirectly mandated by FDA through “Guidance by Warning Letters”, such as the requirement for “Review of Electronic Audit Trails “ which has been quoted many times in FDA warning letters. Attend the new Labcompliance Audio seminar to learn everything about Annex 11, and receive 10+ best practice guides for easy implementation.

Learning from Recent FDA GLP Warning Letters

The number of FDA warning letters issued by the FDA in the area of Good Laboratory Practice regulations has been increasing over the last couple of  years. Examples for deviations are: master schedule not maintained, copies of protocols not maintained, studies not inspected, final study reports not reviewed, complete protocols not maintained, inadequate reports of study protocols, inadequate characterization of test and control articles, inadequate equipment calibration, no archives for storage and retrieval of test data, study data not promptly recorded, study data not signed, revisions to approved protocols not documented, and protocols did not contain all required information, They are useful to learn what inspectors are asking and what mistakes other companies make so you can avoid them. The quoted warning letters can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-275, 270 and 265To avoid GLP related 483's and Warning Letters  attend the audio seminar  "Learning from Recent Warning Letters Related to Good Laboratory Practices" .The seminar reference material includes GLP checklists, SOPs and 13 Waning Letters with deviations related to GLP.

Japanese Guidelines for Computerized Systems and Electronic Records&signatures available

Some time ago the Japanese Ministry of Health, Labour and Welfare(MHLW) has published a "Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs". More recently the document has been translated into English by a CSV study group. With 25  pages the guideline is quite detailed, for example it guides user firms through the entire validation process from design qualification to the validation report. The guideline has no specific sections on electronic records and signature compliance but refers to an earlier document with the title "Use of Electronic Records and Electronic Signatures in Submission for Approvals and Licenses of Medical Products". This document is available through the Labcompliance Users Club. To register to the Usersclub Click here ,

More EMA GMP Inspections caused by significant quality or GMP problems

It is well known that the number of FDA GMP inspections has been increasing over the last couple of years. Now the European Medicines Agency (EMA) also reported increasing numbers of GMP inspection. According to the EMA's 2011 Annual Report 2011 the number of GMP inspection requests (375) exceeded the forecast (245). Several factors contributed to this increase, including an increase in active pharmaceutical ingredient (API) inspections and an unusual number of 'for cause' inspections, owing to significant quality or GMP problems at multi-product sites which involved both finished products and APIs. To read the report, 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 "Handling Security Patches". To download your free copy, go to the Network Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2011). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Using Electronic and Digital Signatures in Regulated Environments
    Requirements and Tools for compliance and efficient Implementation
    Recorded
  2. Validation of Analytical Methods for GLP and Clinical Studies
    Learn how to design, prepare, conduct and document for FDA compliance
    Recorded
  3. Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    Recorded
  4. Understanding and Implementing the New EU Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    Recorded

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Publishers Note

PUBLISHER'S NOTE: Some of the documents presented in this News section may require registration to the Labcompliance Usersclub to access their information. At the time of the News release, all links to other websites functioned, but Labcompliance cannot guarantee the accuracy of the information and that the links will not disabled.