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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

 August 1, 2013S


System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

September 5, 2013


Analytical Equipment Qualification and System Validation for FDA Compliance

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

September 12, 2013


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

October 10, 2013


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 July 2013

New FDA Guidance for Stability Testing of Generic Drugs

The  guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug and Cosmetic Act
that support ANDAs follow the stability recommendations provided in the International Conference on Harmonization (ICH) stability guidances.Q1A to Q1E. Currently, the only published direction from FDA on stability testing for ANDA is contained in a 1995 FDA Office of Generic Drugs (OGD) letter to industry. Although adequate in the context of other guidance existing at that time, this recommendation is no longer sufficient to serve as a basis for compliant stability testing for ANDAs so generic drug manufacturers are required to follow the new guidance.. To learn everything about ICH guidelines for stability testing attend the Labcompliance audio seminar
Stability Testing in Pharmaceutical and API Industry and receive 10+ best practice guide for easy implementation.

Learning from Recent FDA GMP Warning Letters

The number of FDA warning letters issued by the FDA and follow-up activities such as import alerts, product recalls and fines have been increasing over the last couple of  years, especially in the area of Good Manufacturing Practice regulations. Warning letters and 483's are ideal tools to prepare an organization for FDA inspections. They are useful to learn what inspectors are asking and what mistakes other companies make so you can avoid them. While FDA regulations and even guidance documents don't change for long time, FDA inspection practices do. And since they have to be approved by FDA management they do not express the opinion of single inspectors but FDA's current thinking. They are much more up-to-date than regulations and FDA guidelines. And even though most FDA warning letters are publicly available on the FDA website, it is difficult to find the ones relevant to GMP regulations Attend the new Labcompliance seminar on GMP regulations to learn about most frequently cited GMP related violations and how to avoid them. In addition attendees can access more than 30 Warning Letters through instant web download

USA 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. So far Switzerland, Australia and Japan have been on the list.  The EC has now approved the US request following a comprehensive audit of the FDA’s regulatory and inspectional oversight of APIs. The audit took place from May 13 - 20, 2013. More information is available on the FDA Website.

New Annex 16 to EU-GMP on Certification by a Qualified Person released

The European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release".  The Annex has been revised to reflect the globalization of the pharmaceutical supply chains and the introduction of new quality control strategies. The guidance makes it very clear that the ultimate responsibility for the performance of an authorized medicinal product over its lifetime; its safety, quality and efficacy lies with the marketing authorization holder (MAH). However, the responsibility for ensuring that a particular batch has been manufactured in accordance with its marketing authorization, with EU Good Manufacturing Practice or equivalent and that it is in compliance with the laws in force in the Member State where certification takes place and of the destination country of the medicinal product, lies with the QP certifying that batch as being suitable for release. The guidance can be viewed and downloaded from the Website of the European Commission. To learn everything about the role and responsibilities of the Qualified Person, attend the audio seminar : "The Qualified Person in the Pharmaceutical Industry"

FDA Warning for Insufficient Number of System Suitability Test Runs

A drug manufacturer conducted only five test runs instead of six for system suitability testing  for  a dissolution assay: "System suitability conducted for Dissolution Assay per laboratory test methods evaluates only five replicate injections for Relative Standard Deviation (RSD). For NMT 3%. USP requires six replicate injections for instrument precision and accuracy". Other deviations included: E-Records not "readily" available, impact of equipment failures on batch not investigated, inadequate follow up of complaints, and, reference samples not stored under conditions as recommended by the manufacturer. The Warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-239.  To learn about FDA and USP requirements for system suitability testing attend the audio seminar "System Suitability Testing for FDA and USP compliance".

New FDA Draft Guidance on Cosmetic Good Manufacturing Practices

This document provides guidance to industry and other stakeholders (e.g., consumer interest groups, academia, other regulatory groups) on FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics. It is intended to assist industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products. The guidance revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience.
The draft guidance can be viewed and downloaded from the FDA 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 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, 2013). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.2-day Interactive In-Person Seminars with Dr. Ludwig Huber

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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.