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System Suitability Testing in Chromatographic Compendial Methods

Understanding and Implementing Recent Changes in USP and EP .

Recorded

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

February 7, 2008

 

Understanding and Implementing ISO 17025

Requirements, Strategies and and Tool Kits for Laboratory Accreditation

February 14, 2008

 

Validation of Analytical Methods and Procedures

Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance

February 28, 2008

 

Understanding USP Documents and Reference Standards

General Chapters, General Notices, Monographs, Forum, Reference Standards

March 13, 2008

 

Understanding the New USP <1058> for Analytical instrument Qualification

With SOPs, Templates and Examples for Easy Implementation

March 27, 2008

 

 

NEW BOOK EDITION

Dr. Ludwig Huber

 

 

Labcompliance News, December 2007

December 6, 2007

FDA 'Advice' on Using Spreadsheets

Excel is frequently be used in laboratories, offices and manufacturing as sophisticated  calculator  Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice is can also be received from inspection reports. Click here to see some examples and recommendations from Labcompliance.

December 6, 2007

Agilent Technologies Compliance Services Ranked #1 - Again

In a recent blind survey mailed to LCGC subscribers, Laboratory Decision-makers and Users ranked Agilent as their first choice for general laboratory Compliance Services for the third time. Agilent is way ahead to competition. The new Agilent Enterprise Edition helps laboratories save time and money by providing a single qualification protocol that works across an entire laboratory.

December 10, 2007

New and Revised Text of 21 CFR Part 211 Published

On Dec 4, 2008, the FDA published changes to FDA's drug GMP regulation (Part 211). As announced by FDA's Fred Blumenschein at the 2nd European GMP Conference and reported in the Labcompliance July News this is the first step of a phased approach to modernize GMPs. One of the most interesting is that is mentioned several times, that for certain checks only one signature is required if the first check is made automated equipment. For example, § 211.103 on "Calculation of Yield" reads: Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under § 211.68, be independently verified by one person.

December 10, 2007

New PIC/S Guide for Blood Establishments

The purpose of this document is to provide guidance for GMP-inspectors to used during inspections of blood establishments. However, the document does also give an insight into the thinking and concerns of inspectorates and so could provide some useful information for blood establishments relating to the collection, preparation, storage, dispatch, quality control and quality assurance of blood and blood components..

December 12, 2007

How  Much Can You Change Compendial Method?

There have been many discussions on how much a standard method method can be changed before it is not a standard any more. Now USP makes recommendations in the in the updated USP chapter <621> that has been published most recent supplement to USP 30. Horacio Pappa of USP has informed the audience of the Middle east USP conference about the chapter's and he also gave further information on other changes. The chapter recommends limits for HPLC and GC papraters, e.g.; r HPLC and GC parameters More details are available in next Labcompliance Audio seminar. Reference material  will include SOPs of system suitability and on Change vs. Adjustment of Compendial methods. Also Mr. Pappa's USP presentation will be part of the seminar hand out, as well a presentation from FDA's Moheb Nasr with tests and acceptance criteria for HPLC system suitability testing. For more information click here.

December 17, 2007

PIC/S Explanatory Notes on the Preparation of a Site Master Plan

Site Master Files are prepared by manufacturers and contain specific
information about the quality assurance, the production and/or quality control of
pharmaceutical manufacturing operations carried out at the named site and any
closely integrated operations at adjacent and nearby build. The aim of these updated Explanatory Notes is to guide manufacturers of medicinal products in the preparation of a Site Master File that can be useful to the regulatory authority in planning and conducting GMP inspections.

December 17, 2007

Labcompliance in 2007

2007 was an other great year for Labcompliance and website visitors: new products, new services, and significantly increasing number of visitors were just a few highlights. We delivered 25 audio seminars with far over 1000 attendees, we launched a new Web Design with a total of six tutorials. The Labcompliance Usersclub now includes more than 400 documents for instant downloads and the Newsletter with the free Document of the Month enjoys more than 14,000 subscribers. We are looking forward to 2008 with more new products. We will celebrate our 10 years anniversary and will run our 100th audio seminar. We thank all visitors for ongoing support.  

New Audio Seminars - Schedule for Q1/2008

  1. System Suitability in Chromatographic Compendial Methods (188)
    Understanding and Implementing Recent Changes of USP and EP
    Recorded
  2. Validation and Use of Excel® Spreadsheets in Regulated Environments
    (187)

    Comply with GxPs, Part11, HIPAA, SOX and other regulations.
    Recorded
  3. Understanding and Implementing ISO 17025 (189)
    Requirements, Strategies and Tool Kits for Laboratory Accreditation
    Recorded
  4. Validation of Analytical Methods and Procedures (190)
    Conduct and Document for Efficiency and FDA, USP/EP and ISO 17025 Compliance
    Recorded
  5. Understanding USP Documents and Reference Standards (191)
    General Chapters, General Notices, Monographs, Forum, Reference Standards
    Recorded
  6. Understanding the New USP <1058> for Analytical Instrument Qualification
    With SOPs and Case Studies for Easy Implementation
    Recorded
  7. Learning from Recent FDA Warning Letters Related to Computer Validation
    and Part 11

    With Clear Recommendations for Corrective and Preventive Actions
    Recorded

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