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


 

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

 

Eight Steps for Cost-effective Laboratory Compliance
Up-to-date overview, hot topics and trends.
March 29, 2012

 

FDA/EU Compliant Training for Laboratory Personnel

What to train - How much to Train - How to Document Effectiveness

Recorded

 

Implementing the New USP Chapter <1224> for Analytical Method Transfer

With SOPs, templates and examples for effective implementation

March 15, 2012

 

Quality by Design (QbD) for  Development and Validation of Analytical Methods
Learn how to design robustness for easy transfer and to avoid OOS situations
Recorded, available at any time

 

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime
Recorded, available at any time

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and  get real world case studies for testing
Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded, available at any time

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded

 

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

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

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

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

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

 

 

Labcompliance News February 2012

FDA issues Guidance on Biosimilar Product Development

On Feb 12, 2012, the U.S. FDA issued three draft guidance documents on biosimilar product development. The three guidance documents provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency. The titles of the three guidance documents are: 1) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 1) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product:, 2).Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product  3) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: According to the guidance a sponsor must demonstrate that the proposed product is biosimilar to a single reference product that previously has been licensed by FDA. Preclinical and clinical studies are required to demonstrate similarity.The guides can be downloaded from the FDA Website. To get a good overview on the registration process and quality control requirements for biopharmaceutical products attend the Labcompliance seminar: FDA Compliance for Biopharmaceutical Laboratories.

The USP <1224> for Method Transfer is coming in May: Are you ready?

USP Chapter <1224> was approved in June 2011. It will be official in May 1st 2012. The chapter presents for options for controlled transfer and recommends the risk based approach for transfer studies.  Register for the Labcompliance audio seminar "Implementing the New USP Chapter <1224> for Analytical Method Transfer" to learn everything about the new chapter and receive 10 best practice guides, e.g., SOPs, examples and checklists.

FDA Warning Letters in 2011 Increased 155% from 2010

Elizabeth H. Dickinson, Acting Chief Counsel of the Food and Drug Administration, reviewed FDA's recent enforcement history as a keynote speaker at  at the New York State Bar Association’s Annual Meeting in New York City on January 26. Ms. Dickinson outlined the number of Warning Letters issued in 2009, 2010, and 2011. From 2009 to 2010 the number increased from 474 to 673 (42%) and to 1720 in 2011. This was an increase of 155% from 2010 to 2011. This high number of warning letters confirms that the FDA is fully engaged and highly-focused on enforcement. For more information, click here. To learn everything about preparation for FDA inspections and how to avoid  Warning Letters, we recommend to look at FDA Inspection Package from Labcompliance.

EMA Guideline on Quality of Herbal Medicinal Products Final

The guideline covers the general quality aspects of herbal medicinal products  including traditional herbal medicinal products for human use. The guideline should be read in conjunction with Annex 7 “Manufacture of Herbal Medicinal Products” of Good Manufacturing Practice (GMP) for Medicinal Products, Volume 4, Rules Governing Medicinal Products in the European Union; GMP recommendations should be respected. The guide includes sections on preparation of herbal medicinal products, control of starting materials and control tests of herbal medicinal products, The guideline is available on the EMA website.

Inadequate Transfer of analytical methods cited in FDA Warning Letter

An inspection of a drug manufacturer in July 2011 ended with several observations were related to inadequate transfer of analytical methods. In one instance the SOP did not require the receiving laboratory to demonstrate suitability for intended use No specific reason was given. Another SOP was found to be inadequate because it listed several reasons why formal transfer is not required, for example, the analysis technique was already in use at the receiving: laboratory.
While the USP draft chapter <1224> describes waivers as one possible option for method transfer, obviously the justifications given by the company have not been accepted by the inspection team. The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-261. Non members can preview excerpts. To learn everything about FDA's expectation for validation and transfer of analytical methods, attend the Labcompliance audio seminar and receive 10+ best practices guide for easy implementation.

English Version of the New Chinese GMPs available on the WHO Website

China is becoming one of the biggest pharmaceutical market worldwide. Companies selling medicinal products to China must comply with Chinese Good Manufacturing Practice regulations. In March 2011 new GMPs  have been released  and new establishments should have been compliant since the same time. Existing sterile manufacturers (blood, vaccine, injection products) must comply before Dec 31, 2013, all other existing establishments must comply before Dec 31, 2015. The new GMPs are based on the WHO GMPs and are much more detailed than the previous version from 1999, for example, the number of chapters did go up to 313 from 88. In many areas they are also more detailed and more clear than equivalent US FDA GMP regulations. The Chinese State Food and Drug Administration (SFDA) is launching foreign GM inspections using the risk based approach. The English translation of the new Chinese GMPs is available on the WHO  and on the SFDA 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: Qualification of PC Clients". 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 February 29 , 2012). 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.

Audio Seminar Schedule

 

  1. Implementing the New USP Chapter <1224> for Analytical Method Transfer
    With SOPs, templates and examples for effective implementation
    March 15, 2012
  2. Eight Steps for Cost-effective Laboratory Compliance
    Up-to-date overview, hot topics and trends.
    March 29, 2012

New or Updated Sites

Click here to tell others in your company about compliance news

 

Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com