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Version 5 just released

Now with Qualification of Virtual Networks

With three audio seminars

With 26 SOPs

 

56 Usersclub Additions

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

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

 

GMP Compliance for Quality Control and Contract Laboratories

Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation

Recorded, available at any time

 

Are You ready for FDA's 'New' Inspection and Enforcement Practices?

With Industry Proven Tool Kits for Preparation, Conduct and Follow-up

Recorded, available at any time

 

FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation
Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

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

Recorded, available at any time

 

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

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Understanding and Implementing the New EU-PIC/S Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

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

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

 

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

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

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.

 

 

 

 

FDA Continues with Part 11 Inspections and related Warning Letters

Violations related to FDA's Part 11 are still an issue. Recent examples are a series of inspections with warning letters related to security, integrity and availability of electronic records. Here are a few  citations: "Your firm’s HPLC systems do not have restrictions in place to prevent any change or deletion of analytical raw data". "During the review of the chromatography data, our investigator noticed that the raw data retained does not include the run sequence or the processing method used to perform the peak integrations" and "Several of the HPLCs had the audit trail functions disabled; therefore, there is no assurance that the data generated using these HPLCs is accurate" .The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-287, 286 and 284. Non members can preview excerpts. A very effective way to learn everything about most up-to-date FDA requirements and to get tools such as a master plan, step-by-step implementation guide, SOPs and checklists is to study  the new Part 11 compliance package. The package also includes examples of 20+ full text warning letters with citations related to Part 11.

FDA Releases a Draft Guidance on Elemental Impurities 

Shortly after ICH has published the draft guidance on elemental impurities the FDA released the same documents as FDA draft guidance.  The guidance lists 4 classes of elements with permitted daily exposure limits and includes risk based control strategies for drugs and APIs to reduce the elements to be below the limits. The guidance does not describe analytical procedures but refers to related regional Pharmacopeias. The guidance can be viewed and downloaded from the FDA website. The elements and limits are similar but not identical to the USP chapter 232. To learn about similarities and differences between USP and ICH attend the recent Labcompliance audio seminar 'Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines'. .

New Part 11 Compliance Package for effective Training and Trouble-free Implementation

Labcompliance is introducing Version 3.1 of it's popular Part 11 Compliance Package . The content has been updated with 20+ new or updated good practice guides, e.g., master plan, implementation guide, SOPs. checklists, examples and forms. The new package is ideally suited to prepare companies for the ongoing FDA Part 11 inspections with focus on security, integrity and availability of e-records. For example, 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

FDA Requests a Retrospective Review of all Drugs manufactured at a Facility after Improper Laboratory Testing

During a recent inspection of a drug manufacturer the FDA found significant  deficiencies during drug testing.  In the follow-up warning letter the FDA requested a retrospective review of all drugs manufactured at that facility. The letter reads: "The investigation should provide detailed descriptions of other incidents where your quality unit failed to ensure proper testing of materials and should include a retrospective review of all test results generated by your laboratory personnel. If other instances of non-existent, inaccurate, or unreliable test results are found, your investigation should assess the impact of these discrepancies on the quality of the drug products manufactured at your facility". The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-284. Non members can preview excerpts. Such extensive follow-up with possible product recalls is part of FDA's new inspection and enforcement practice. To learn more about the new practice attend the new Labcompliance audio seminar 'Are You ready for FDA's 'New' Inspection and Enforcement Practices?'.

New Article on Analysis of Biopharmaceuticals for ICH Q6B Compliance

The article written by David Neville and Andrew Kenyon highlights some of the analytical techniques that are used when setting specifications for biomolecules to meet the guidelines set out in the document ‘Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products according to ICH Q6B. Analytical  techniques as discussed in the article include Electrophoresis, Mass Spectrometry, N-linked Glycosylation, Quantitative PCR (qPCR) and ELISA As of October 2013 the article is available on the in-PharmaTechnologist.com website It also includes a link to the draft proposals. Copyright rests with the publisher.

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 "Revalidation of Software and Computer Systems". To download your free copy, go to the Macro and Spreadsheet Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 15, 2012). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here

Audio Seminar Schedule

  1. Are You ready for FDA's 'New' Inspection and Enforcement Practices?
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up
    Recorded, available at any time
  2. FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
    With a tool kit for cost effective implementation
    Recorded, available at any time

New or Updated Sites

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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.