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Jan 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

 

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

Recorded

 

FDA/EU Compliant Handling of OOX Test Results

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

Recorded

 

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

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 Article about the Updated USP Chapter <1223>: Validation of Alternative Microbiological Methods

On June 1, 2015, USP published a substantially modified chapter <1223> in the second supplement to USP38/NF33 with an official date of 1st December 2015. The article, written by Michael J. Miller, PhD,  reviews the most notable changes and compares them with what is recommended in the Parenteral Drug Association (PDA) Technical Report Number 33 and the proposed revision to European Pharmacopoeia (Ph. Eur.) chapter 5.1.6. . As of September 2015 the article is available on the European Pharmaceutical Review website.  Copyright rests with the publisher.

PIC/S GMP Annex 15 "Validation and Qualification" Effective on October 1

The Pharmaceutical Inspection convention Cooperation Scheme (PIC/S) has adopted the The EU GMP Annex 15  as PIC/S Annex 15.  The Annex has been significantly updated compared to the version of 2001 but also compared to a draft version from 2014. The Annex is in line with other modern related documents such as ICH Q8/9/10/11 and has components from Quality by Design,  Risk Assessment and Quality Systems, for example, continuous lifecycle management, and continuous  verification and improvements. With the adoption by PIC/S the Annex will be expanded from EU countries to worldwide acceptance. Currently PIC/S consists of 46 participating regulatory authorities worldwide, including the 28 EU member states, but also  the US FDA, Health Canada and many international agencies from Latin America, Africa, Asia and Australia. Both the EU and PIC/S guidelines take effect October 1, so now it is a good time to learn about the Annex.. Attend the new Labcompliance Seminar to learn everything about the requirements and how to implement the new Annex.

Why are there so many NEW  Guidelines on Transfer of Analytical Methods?

Since USP released the first version of chapter <1224> for transfer of analytical procedures several other organization also developed guidelines on the same topic. First USP released a second version of its chapter, ISPE and WHO published guidelines as part of their technology transfer initiatives, the new EU GMP Chapter 6 gives some specific advice and also the most recent FDA Method Validation Guidance includes a related chapter. In addition, private work groups have published position papers related to this topic, such as the 34 page positioning paper: "Transfer of analytical procedures" (2014) by Limberger and colleagues.  So the question  is why are there so many documents related to this topic? WHO guidelines on transfer of technology in pharmaceutical manufacturing gave an explanation: "The ever changing business strategies of pharmaceutical companies
increasingly involve intra- and intercompany transfers of technology (including analytical methods) for reasons such as the need for additional capacity, relocation of operations or consolidations and mergers". There is also  an increasing trend for outsourcing of analytical testing with a need for method transfer. The importance of method transfer is also demonstrated through FDA inspections So many guidelines with lots of different requirements raise a lot of questions for pharmaceutical laboratories. focusing on analytical method transfer. Attend the new Labcompliance Seminar to learn everything about the new guidelines for method transfer and get tools and strategy for cost-effective and compliant implementation.

New article on GMP Supervision and Inspection of Manufacturers for Medicines in the EU Market

The objective of this excellent paper is to explain the EU system in order to increase awareness and facilitate cooperation on GMP between EU regulators, the pharmaceutical industry and regulators outside the EU. The paper starts with a brief introduction to the EU and its regulatory system for medicines, which gives the framework where the GMP regulatory system operates, then addresses more specifically all the main aspects of how compliance with GMP is ensured for medicines in the EU market. A large section is dedicated to how equivalence among the EU Member States is achieved and maintained, which is one of the aspects less known and understood by non-EU regulators and industry. As of September 21, 2015 the article is available on the PDA Website.  Copyright rests with the publisher.

ICH Q3D on Elemental Impurities published as FDA Guidance

The guidance was developed within the Quality Expert Working Group of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH process. The document has been endorsed by the ICH Steering Committee at Step 4 of the ICH process, November 2014, and revised to correct several inconsistencies, December 2014. At Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. The guidance id available on 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 Best Practice Document "SOP: Handling of Out-of-Specification test Results". 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 September 15, 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.