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50 New Usersclub Additions

 

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

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

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

September 13, 2012

 

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

August 30, 2012

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

Recorded, 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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

Recorded
Available at any time

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

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

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, 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

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

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 August 2012

USP Proposes Changing the General Chapter 'Weight and Balances'

The USP General Chapters Expert Committee proposes replacing the existing chapter Weights and Balances 41 with a new chapter titled Balances. In this new chapter, requirements for balances used for materials that must be accurately weighed are redefined in terms of repeatability and accuracy. The repeatability requirement is similar to the one in the current chapter 41, but in order to reflect current metrology practices, the limit has been changed from 0.1% to 0.10%; and the coverage factor has been changed from 3 to 2. The draft version of the new chapter has been published in the Pharmacopeial Forum 38 (5). Subscription to the PF is free but visitors must register.

EMA Releases Guideline on 'Real Time Release Testing'

Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a release decision process, an approach that is called Real Time Release Testing (RTRT). The new guideline addresses the requirements for application of RTRT to different kinds of products e.g. chemical and biological products and its scope is to facilitate the introduction of RTR testing. The guideline is a revision of the guideline on parametric release and does not introduce new requirements. To view and download the guideline, click here.

New Guideline on the use of Near Infrared Spectroscopy (NIRS)

Near Infrared Spectroscopy (NIRS) is a technique, usually requiring tandem chemometric statistics, with a wide and varied use in pharmaceutical, chemical, physical and process analysis. This includes identification, qualification and assay of pharmaceutical starting materials, intermediates and finished products and verification of physicochemical properties. NIRS also constitutes one of the major techniques in Process Analytical Technology (PAT) and may also be used as part of a Real Time Release Testing (RTRT) strategy. When used as such, NIRS is underpinned by the principles of Quality by Design (QbD). The EMA has published guideline on the use of Near Infrared Spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations. The view and download the guideline, click here.

ISPE Releases New Guidance for 'Pharmaceutical Change Management'

ISPE announced that it has released the latest volume in the Product Quality Lifecycle Implementation (PQLI®) series, Change Management System as a Key Element of a Pharmaceutical Quality System. The Guide, which is Part 3 of the PQLI series, provides practical, real-world strategies that companies can use to implement the change management recommendations of ICH Q10. It is the only change management guide written expressly for the pharmaceutical industry. For more information and ordering, click here,

FDA Warning Letter Issued for Missing Verification of Analytical Methods

FDA expects compendial and other methods and procedures to be verified under actual conditions of use. This became clear during a recent inspection of an API manufacturer that resulted in a warning letter. The letter reads:  'Failure to verify and document the suitability of testing methods under actual conditions of use.  Specifically, your firm failed to conduct and document a verification under actual conditions of use of the following laboratory testing methods: related substances method (HPLC) and identification (IR) method used for release and stability testing, for microbial and endotoxin testing methods used to monitor the quality of the purified water, and assay (titration) method for release and stability testing of xxx API. FDA felt the company's response was inadequate. The letter also requested to provide a risk assessment for possible impurities present in APIs. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-274.  To learn how to verify compendial and other analytical methods for FDA regulated environments attend the audio seminar  "Verification of Compendial Methods according to the New USP Chapter <1226>" The seminar suggests criteria and steps for risk based verification.

FDA Video explains the 'Accelerated Approval Program'

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker that is used in clinical trials as an indirect or substitute measurement that represents a clinically meaningful outcome. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. FDA has published a video that explains the program. To view the video, click here.

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 "Retrospective Validation of Computerized Systems". To download your free copy, go to the Spreadsheet Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 31 , 2012). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

 

  1. 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
    August 30, 2012

  2. FDA Compliant Use of (Certified) Reference Material
    Strategies for selection, purchasing, testing and documentation
    September 13, 2012
  3. Laboratory Equipment Qualification according to USP <1058>
    With SOPs, Templates and Examples for Easy Implementation
    September 27, 2012

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