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Sept 2015

Version 4 just released

With strategies and tools for fast, cost-effective Laboratory Accreditation

With Quality Manual and  SOPs for easy implementation


71 New Usersclub Additions
last update
September 1, 2015

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


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


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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time5


Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time


Analytical Instrument Qualification According the new Revision of
USP <1058>

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time


Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
Recorded, available at any time


Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available at any time


Quality by Design (QbD) for Development and Validation of Analytical Methods

Learn how to design robust analytical for easy transfer and to avoid OOS situations



FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results



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


Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

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


Managing Electronic Raw Data in Regulated Environments

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

Recorded, available on demand


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

Learn what the FDA is looking for and how to respond



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.




Computer Validation and Part 11 Cited in recent FDA Warning Letters

Violations related to Computer Validation and other Part 11 requirements are still an issue. Recent examples are a series of inspections with warning letters related to inadequate computer validation practices and security, integrity and availability of electronic records. Here are a few  citations: "Your firm’s response stated that your firm will create a validation program for all uncontrolled computer systems, create a new standard operating procedure (SOP), and retrain all analysts performing analytical tests." and " As part of your response, provide a complete validation plan for your laboratory computerized systems. This plan should include an audit trail component and other appropriate controls to prevent deletion and overwriting of data".The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-300, W-298, W-297 and W-293, Non members can preview excerpts. To learn everything about FDA's recent and on-going warning letters related to computer validation and other  Part 11 requirements attend the Labcompliance audio seminar Learning from Recent Warning Letters related to Part 11 and Computer Validation

ICH answers Frequently asked Questions related to ICH Q7

In order to facilitate the implementation of the Q7 Guidelines, the ICH Q7 Implementation Working Group published a Question and Answer Document related to the ICH Q7 guidelines: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Since the ICH Q7 Guidance was finalised in 2000, experience with implementing the guidance worldwide has given rise to requests for clarification of uncertainties due to the interpretation of certain sections. This Question and Answer (Q&A) document is intended to respond to those requests. PIC/S contributed to this document by selecting and reviewing relevant Q&As that had been collected from training sessions since the implementation of Q7 and transferred the output of these reviews to the ICH Q7 IWG for consideration and consolidation, as appropriate. Additional questions were developed based on responses from an ICH survey. PIC/S further contributed to the development of the document as an ICH Interested Party. The Q&As can be downloaded from the ICH website. .

Updated Primer: Compliance for Biopharmaceutical Laboratories

This 44-page primer has been written by Dr. Ludwig Huber and published by Agilent Technologies. It is  intended to introduce biochemists and biologist working in biopharmaceutical development and manufacturing to FDA and equivalent international requirements. It is also useful for quality managers and staff and for everyone else involved in the registration process of biopharmaceuticals. The primer also gives strategies and specific recommendations for regulated laboratories on how to implement the requirements in the most cost effective way. The update takes into account new developments such as Quality by Design and FDA's new guide on Validation of Analytical Methods and procedures. The primer is available from Agilent as PDF file and as paper booklet.

ICH publishes Maintenance Procedures for ICH Q3C Impurities: Volatile Impurities

Draft Recommendations for Revision to the ListThe International Conference on Harmonisation has developed maintenance procedures for revising the permitted daily exposure (PDE) of solvents included in the Q3C guidance. Draft Recommendations are made for Triethylamine and Methylisobutylketone. Final Recommendations are made for Tetrahydrofuran, N-Methylpyrrolidonea and Cumene. The document can be downloaded from the FDA website, This web page makes available to the public all recommendations, decisions, and other information related to the revision of the Q3C tables and list. 

EC publishes a new Revision of Annex 16 on the Qualified Person

The Annex "Certification by a Qualified Person and Batch Release" has been revised to reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. his Annex provides guidance on the certification by a Qualified Person (QP) and on batch release within the European Union (EU) of medicinal products for human or veterinary use holding a marketing authorisation (MA) or made for export.
Deadline for coming into operation: 15 April 2016

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 Best Practice Document "SOP: Responding to FDA Warning Letters". 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 October 31, 2015). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.


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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.