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



 

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

 

Learning from Recent Warning Letters Related to Good Laboratory Practices

For Preparation of FDA and International GLP Inspections

Recorded, available on demand

 

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

Sample generation - method development - validation - documentation

Recorded, available on demand

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded, available on demand

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded, available on demand

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded, available on demand

 

Validation of Excel® Spreadsheets for Regulated Environments: Step-by-Step

With Case Studies and Validation Protocols for Easy Implementation.

Recorded, available on demand

 

Understanding and Preparing for FDA's New Part 11 Inspection Program

With 10+ Best Practice Guides for Easy Implementations

Recorded, available on demand

 

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

With Case Studies to Avoid and Respond to 483's and Warning Letters

Recorded, available on demand

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available on demand

 

New  release in
2010 

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

 

 

Labcompliance News, December 2010

 FDA Releases New Guidance for ANDAs:  Impurities in Drug Products

This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC)information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting original abbreviated new drug applications (ANDAs)and ANDA supplements for changes that may affect the quantitative or qualitative degradation product profile. The guidance also provides recommendations for establishing acceptance criteria for degradation products (specifically, degradation products of the active ingredient or reaction products of the active ingredient with excipients and/or immediate container/closure system) in generic drug products. The guidance will replace an existing 1998 draft guidance of the same name. To read the guidance, click here.

FDA Warning: Stability Indicating Methods not Selective, not Validated or not Followed

A pharmaceutical manufacturer has received an FDA warning letter for manufacturing violations related to using inadequate tests methods for stability testing. For example, the company did not use meaningful, and specific tests methods, the methods have not been validated or stability test methods have not been followed. The letter reads "Some of your firm's analytical methods have not been validated to demonstrate that they are stability indicating. In other instances, test methods that you claim to be stability indicating are inadequate or not followed by your firm." The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-229.  To learn everything about FDA compliant development, validation and use of stability test methods, attend the audio seminar  "Development and Validation of Stability Indicating Methods".

EMA Publishes Guideline on Similar Biological Medicinal Products

Bio-generic drugs are a hot topic in US and Europe. While traditional generic drugs don’t have to go through the complete development process and marketing is possible upon approval of Abbreviated New Drug Applications (ANDAs) without the need for preclinical and clinical studies, current US law provides no abbreviated submission for bio-generic drugs or as they are called by the FDA: follow-on biologics. Instead, manufacturers of biopharmaceuticals must perform full clinical trials and create a full BLA or NDA  for such products. The situation is different in Europe where abbreviated submissions are possible for bio-similar drugs, as they are called in Europe, but still some preclinical and clinical studies should be conducted. In response to the need for guidance on what to do the European Medicines Agency has published recommendations for non-clinical and clinical studies, for example for monoclonal antibody (mAb) containing medicinal products claiming to be similar to another drug already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects 

EMA Publishes Guidance on the Investigation of Bioequivalence

The concept of establishing bioequivalence is fundamental for generic drugs. The purpose is to demonstrate equivalence in biopharmaceutics quality between the generic medicinal product and a reference medicinal product in order to allow bridging of preclinical tests and of clinical trials associated with the reference medicinal product. This new guideline focuses on recommendations for bioequivalence studies for immediate release formulations with systemic action. The scope is limited to chemical entities. Recommendation for the comparison of biologicals to reference medicinal products can be found in guidelines on similar biological medicinal products. To read the guideline click here.

FDA Expects Forced Degradation in the Presence of all APIs, Warning Letter Says

An API manufacturer received a warning letter as a result of inadequate forced degradation for the development and validation of stability indicating methods. The company conducted forced degradation of individual drug substances expected to be present in finished drugs. FDA expects forced degradation in the presence of all APIs. The warning letter reads: "You performed forced degradation studies on all (drug substances) individually, not on the xxx. We consider these forced degradation studies incomplete. They should include the forced degradation in the presence of all (drug substances), and their related impurities/related substances and degradation products to ensure selectivity of the method. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-243.  To learn everything about FDA compliant forced degradation and about development and validation of stability test methods, attend the audio seminar  "Development and Validation of Stability Indicating Methods".

Labcompliance ISO 17025 Tutorial Updated

We have updated the popular tutorial for ISO 17025. Now it includes eight key steps towards accreditation and more details on implementing management and technical requirements. To access the free tutorial, click here.

Outsource Analytical QC Testing Yes or No?

The article written by Paul Smith and published by Pharmaceutical Formulation and Quality  tries to answer the question if outsourcing analytical QC testing can save money and still provide essential flexibility. Most critical for the answer to this question is the selection of the outsourcing partner the working relationship with that company. Smith gives recommendations for selection the right laboratory for different types of contract analysis. .As of December 2010 the article is available on the Pharmaquality Website. Copyright rests with the publisher.

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 "Training for GMP Compliance ". To download your free copy, go to the FDA Inspection Survival Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 31, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

 

  1. FDA/ICH Compliant Development and Validation of Stability Indicating Methods
    Sample generation - method development - validation - documentation
    Recorded, available on demand

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