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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

 

 

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

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

Recorded, available at any time

 

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 July 2012

New FDA List with New/Revised/Withdrawn Guidances available

FDA CDER has published a list with guidances that are new, have been withdrawn or revised in 2012. For a comprehensive list of all FDA guidances click here.

New Part 11 Compliance Package for Trouble-free Implementation

Labcompliance is introducing Version 3 of it's popular Part 11 Compliance Package . The content has also been updated with 6 new SOPs, one new audio seminars, 4 new forms and 10 new case studies for trouble free implementation. The new package is ideally suited to prepare companies for ongoing FDA Part 11 inspections with focus on security, integrity and availability of e-records. For example, new SOPs are available addressing security and integrity and, checklists, the step-by-step implementation plan and the Part 11 compliance master plan  have been updated accordingly.   For details on content and ordering, click here.

EGA Answers Questions about Biosilimar Medicines

The European Generic Medicines Association (EGA) answers frequently asked questions related to biosimilar medicines on its website, Questions are related to meaning of the term ‘biosimilar’, why are biosimilar medicines being introduced, where is Europe now regarding biosimilar medicines, the regulatory approval process for biosimilars in Europe, the science behind the ‘comparability exercise’, what measures are needed to ensure access to biosimilar medicines, how is quality assured for the manufacture of biopharmaceuticals, how can patients be assured of safety, WHAT cost savings will biosimilar medicines bring to healthcare systems

All Drug and API Manufacturers must Control Elemental Impurities

Elements such as Pb, As, Cd, Pd and others are toxic and according to all GMPs impurities in drugs and drug substances must be controlled. Current Pharmacopeia procedures such as USP <231> are "Non-specific, insensitive, time-consuming, labor intensive, and more often than hoped, yield low recoveries or no recoveries at all:. Ref: Wang, T. J.Pharm&Biomed Anal. Vol 23 (2000), 867-890. The figure below shows a comparison of recovery studies between USP <231> and modern equipment such as ICP-MS.

 

 

Because of such high inaccuracy many manufacturers of drugs and drug substances don't analyze elemental impurities and obviously FDAs don't pay too much attention. This is changing. USP has developed chapters specifying elements and limits based on toxicity and analytical procedures based on ICP-MS and ICP-OES. The final text is already published in the current Pharmacopeia and will be effective by December 1, 2012. Until April March 2014 both chapters <231> and <233> can be used, in April 2014 all references to the existing chapter <231> will be removed and all analyses have to be performed according to <233>. In addition ICH is developing a guidance Q3D with similar limits as defined by USP <232>. A Step 2 document is expected to be published soon. Manufacturers of drugs, drug substances and raw material must control elemental impurities and perform the related analyses either in-house of through contract laboratories, but still there are many questions, e.g., about the most suitable analysis techniques, in-house testing vs. outsourcing, what exactly is required when, verification of compendial procedures, selection of validation of alternative procedures and so on. Attend the Labcompliance audio seminar to get answers to all these and more questions and receive 10+ best practice guides such as SOPs, checklists and case studies for easy implementation.

Half of FY11 FDA GMP Warning Letters tied to Batch Failures

Half the pharma firms sent FDA GMP warning letters in fiscal 2011 were criticized for failing to thoroughly investigate the failure of a batch. To read the full story, click here. To learn more about failure investigations and to receive checklists and SOPs for easy implementation attend the Labcompliance Seminar Handling Out-of-Specification Tests Results and Failure Investigations

FDA Update on Ongoing-Activities and Product Recalls

Two FDA professionals gave update on FDA activities at the APhA Annual Meeting (New Orleans, LA). The presentation had two objectives: 1. Describe FDA activities and 2. State how changes in FDA regulations and actions will affect participant’s practice. FDA mission,, approval and actions, drug safety information, safe Use Initiative REMS/Medication Guides, Patient Medication Information, total number of product recalls from FY 2007 to Q1 2012, sentinel initiative, OTC news, drug shortages and supply chain integrity. The presentation is available on the FDA Website

MHRA answers Frequently Asked Questions related to OOS

The UK Medicines and Healthcare products Regulatory Agency (MHRA) answers 20 frequently asked questions at the MHRA website. Questions are related to using outlier tests, re-sampling, number of repeat tests. who should investigate OOS, when should QA and manufacturing get involved, when can test results be averaged  and more, To learn more about failure investigations and handling OOS and OOT situations and to receive checklists and SOPs for easy implementation attend the Labcompliance Seminar Handling Out-of-Specification Tests Results and Failure Investigations

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 Laboratory Compliance Package website.  Scroll down and click on the corresponding ICON on the left (offer expires on August 15, 2012). 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

 

  1. 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

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