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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


Validation and Use of Excel Spreadsheets in Regulated Environments
Comply with GxPs for drugs, APIs and Devices, with FDA Part11, and with EU-PIC/S Annex 11
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


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

With Strategies and best Practice Guides for easy Implementation

 Recorded, available at any time


System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available at any time3


Analytical Equipment Qualification and System Validation for FDA Compliance

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

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

September 26, 2013


FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time


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


Elemental Impurities According to the Final USP Chapters 232/233

With updates on the new ICH Q3D Guide: Elements, Limits and Schedule

Recorded, available at any time


Quality by Design (QbD) for Analytical Method Development and Validation
Learn how to design robustness for easy transfer and to avoid OOS situations
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

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


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



Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

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


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





Labcompliance News June 2013

How to Qualify Manufacturers of APIs: Questions and Answers

There is a clear global trend to better control  manufacturers of APIs, for example through inspections by agencies and through audits by pharmaceutical manufacturers and 3rd parties. Both manufacturers of APIs and clients are unsure what the exact regulatory requirements are and any published statements are welcome. In light of this the website of the Danish  Health and Medicines Agency might help: The site has a Q&A section related to GMP requirements for manufacturers of active pharmaceutical ingredients (APIs) . Examples of questions are: Who are considered manufacturers of active pharmaceutical ingredients? What documentation is required to substantiate that the active pharmaceutical ingredient has been manufactured in accordance with GMP? Where does the pharmaceutical manufacturer document that active pharmaceutical ingredients have been manufactured in compliance with GMP? What are the consequences if an API manufacturer has not been audited? Even though answers are provided by a single agency. The spirit of the answers may be applicable for most others

New USP Chapters for Elemental Impurities Deferred

USP has deferred proposed 5.60.30 Elemental Impurities in General Notices. This proposed revision suggested a May 1, 2014 date linking General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures to drug product monographs in the United States Pharmacopeia (USP). As such, section 5.60.30 will not be included in the General Notices that will be published in USP 37–NF 32, and therefore there is no requirement for any drug product in the USP–NF to comply with <232> and <233> at this time. The proposed omission of General Chapter <231> Heavy Metals also has been deferred. These deferrals will allow USP to work closely with ICH Q3D to align their activities with the implementation of General Chapters <232> and <233>. For more information, please check the USP website.

New FDA Guidance on Co-development of Two or More new Investigational Drugs

This guidance is intended to assist sponsors in the co-development of two or more new drugs that have not been previously developed for any indication to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during co-development of two or more new investigational drugs. The guidance can be downloaded from the FDA website.

FDA expects an SOP to manage Out-of-Trend (OOT) Situations

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.

Japanese API manufacturers exempt from Individual GMP Certificates for EU Import

Starting on July 1st, 2013, APIs will only be imported into the EU if the active substances are accompanied by a written statement from the competent authority of the exporting third country with a  confirmation that the standards of good manufacturing practice and control of the manufacturing plant are equivalent to those in the EU. Individual manufacturers of countries are  exempt from the need to issue individual GMP Certificates if that country is on a so called ‘White List’, This means the country not only must have equivalent GMPs but also equivalent inspection and efficient enforcement practices. In addition the country must regularly and rapidly provide information on non-compliant producers of APIs. So far Switzerland and Australia have been on the list. Now Japan has just been added to the list. More information is available on the EC website.

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: Measurement Uncertainty in Chemical Testing". 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 July 12). Labcompliance offers more than 130 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.