Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars


 

71 New Usersclub Additions
last update
December 1, 2014

- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters

 

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber.  . 

 

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs. 

 

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

 

New OECD Guide: Using Computer Systems in GLP Studies

Understanding and Implementing the new OECD Guide for Computer Systems November 6, 2014

 

FDA Compliant HPLC Qualification and Performance Testing

Learn how to select, conduct and document the right tests in the right sequence

November 20, 2014

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available at any time

 

Learning from Recent Warning Letters Related to Computer Validation and Part 11

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available with all reference material at any time

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

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

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time

 

Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time

 

Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time

 

Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation

Recorded, available on demand

 

Transfer of Analytical Methods According to the New USP Chapter 1224
With SOPs, templates and examples for easy implementation

Recorded, available on demand 

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

 Recorded, available on demand

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available on demand

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available on demand

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available on demand

 

Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

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

 

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.

 

 

 

New Guidance from OECD on Using Computers for GLP Studies

Almost all guidances on "Validation and Use of Computers" from FDA and related international agencies and industry task forces are targeted to GMP. Now after almost 20 years the OECD has released a new version of the popular Consensus Document: "The Application of GLP Principles To Computerised Systems". Compared to the older version the new one is more detailed and has some very specific requirements. In addition to validation it addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The guide includes all details and what to do but it does not have specific information for implementation. Attend the new Labcompliance seminar to learn everything about the new requirements and get best practice for easy implementation.

USP Publishes a Revision of the general chapter "Validation of Alternative Microbiological Methods"

This proposed revision of general chapter <1223> provides guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods. The revised chapter describes important steps that should be taken to evaluate candidate alternative methods, to select the analytical technology, and ultimately to qualify the method with actual product. These steps include, but are not limited to, identification of a potentially suitable alternative methodology, demonstration that the method is equivalent and applicable as a replacement for a standard compendial method, development of user specifications for equipment selection, and qualification of the method in the laboratory. In addition, this chapter outlines four distinct options for demonstrating equivalence. The revision has been published in USP's free journal "Pharmacopeial Forum", 40-4,  (free registration required)

FDA and EMA require an SOP for Management of Out-of-Trend (OOT) Situations

The updated EU GMP Chapter 6 - Quality control requires a procedure for handling significant atypical Out-of-Trend results. The FDA Guide on Investigating Out of Specifications Test Results for Pharmaceutical Production also mentions out-of-trend situations. "Although the subject of the guidance is OOS results, much of the guidance may be useful for examining results that are out of trend (OOT)". No further details are given. What it can mean in practice became obvious during an inspection of a drug manufacturer that resulted had in several 483 observations. One of them stated: There is no standard operating procedure in place that describes the steps to be followed during an Out-of-Trend (OOT) Investigation, besides, the "OOT Investigation" performed was inadequate. The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-241. Non members can preview excerpts. To learn everything about FDA's expectation for handling Out-of-trend situations, attend the Labcompliance audio seminar and receive 10+ best practice guides for easy implementation, including an SOP on handling OOT situations

Which SOPs are Required by GMP?

This question frequently comes up in GMP trainings. While it is almost impossible to give a 100% complete list for all circumstances, the ECA GMP News did provide a good overview of the written procedures (typically called standard operating procures) that are listed in related regulations. The overview lists SOP as stated in FDA 21 CDR Part 211, in the EU Guidelines to Good Manufacturing Practice of Eudralex Vol. 4 (EU-GMP Guide) and in the WHO guide to good manufacturing practice (GMP) requirements, Part 1: Standard operating procedures and master formulae. The NEWS make a clear statement at the end that "The examples from FDA, EU and WHO provided above are not a finite list".

 "Chromatographic Reintegration must follow an SOP", FDA says

In chromatographic analysis it may happen that peaks need to be reintegrated, for example to adjust peak integration marks. The FDA does not want to leave this practice up to the subjectivity of individual operators but requires to follow a company SOP. This became obvious in a recent warning letter issued to a, API manufacturer. The warning letter reads: "The inspection documented that HPLC processing methods (including integration parameters) and re-integrations are executed without a pre-defined, scientifically valid procedure. A QC operator interviewed during the inspection stated that integrations are performed and re-performed until the chromatographic peaks are “good”, but was unable to provide an explanation for the manner in which integration is performed. Moreover, your firm does not have a procedure for the saving of processing methods used for integration. Your response did not include a description of the method by which chromatograph integrations are to be performed (e.g., what constitutes a chromatographic peak, how shoulder peaks are to be handled, etc.). The warning letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-287. Non members can preview excerpts.

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 "Validation of Software and Computer Systems for ISO 17025". 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 November 15 , 2014). Labcompliance offers more than 150 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here

Audio Seminar Schedule

  1. New OECD Guide: Using Computer Systems in GLP Studies
    Understanding and Implementing the new OECD Guide for Computer Systems 
    November 6, 2014
  2. FDA Compliant HPLC Qualification and Performance Testing
    Learn how to select, conduct and document the right tests in the right sequence
    November 20, 2014

New or Updated Sites

Click here to tell others in your company about compliance news

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.