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Labcompliance News, August 2000

August 21, 2000

US EPA Develops Electronic Records Keeping Rule

The United States Environmental Protection develops the Cross-Media Electronic Reporting and Record-keeping Rule (CROMERRR); Paul Motise from the US FDA disclosed some more details on timing, principles and content at the IVT conference on E-signatures/records on August 14 in Washington.
Timing: Proposed rule: end of 2000, final rule: end of 2001
Principles: Codifies criteria for e-record integrity, authenticity, trustworthy
Will be agency wide, covers records and signatures, echos 21 CFR part 11 principles (nick name has been mentioned to be part 12) and includes elements such as accurate and complete copies (validated data migration anticipated) and signature to records links.

August 18, 2000

EURACHEM-Eurolab Draft on Proficiency Testing

An ad-hoc drafting group of the joint EA-Eurolab-Eurachem Proficiency Testing Working Group. has developed a 12 page Draft Common Position Paper for the Use of Proficiency Testing as a Tool for Accreditation in Testing.
This draft is currently circulated for comment and approval. It is therefore subject to change and may not be referred to as a Eurachem Document until published as such. It is very valuable for those laboratories which consider to participate in proficiency testing schemes.

August 17, 2000

Workshop: Quality in Analytical Laboratories

About 180 attendees from university, industry and testing laboratories attended the workshop in Bangkok on July 27 and 28, 2000. It was sponsored by Agilent Technologies and the Department of Chemistry of the Chulalongkorn University. The workshop was completely sold out, many candidates had to be rejected. There were so many questions, that we could not answer all of them Therefore we have set up a special web site with the agenda, question and answers and some photos of the event. 

August 10, 2000

PDA Technical Report N. 32 on Vendor Audits now Available

Developed in response to an FDA challenge to develop a standard way to assess the structural integrity of acquired software, TR 32 was written by the PDA Supplier Auditing and Qualification Task Group (SA&Q), which included pharmaceutical companies, suppliers, auditors and FDA members who used their experiences with supplier audits and performed research to draft a common practice to satisfy industry needs. The scope of the project included audits of computer products and services and describes how the SA&Q Task Group, led by George J. Grigonis, Jr., Merck and Co., Inc., developed and tested a Process Model and Data Collection Tool. Use of these tools will provide consistent audit information that can be shared within the industry. 1999, 277 pages. 

August 10, 2000

Follow up of joint PDA/FDA Conference on 21 CFR Part 11

At the 2000 PDA/FDA Joint Regulatory Conference
September 11-15 in Washington, D.C.
the following sessions will be held:

Highlights of the PDA/FDA Public Conference on Technical Implementation of Part 11 Breakfast Topics cover archiving, record integrity and audit trails, e-signatures and clinical applications.

Part 11: Challenges and Implementations The many challenges facing FDA investigators as well as industry in the practical implementation of Part 11 regarding electronic signatures, paperless batch records and other related issues.

Roundtable Exchange Lunch: Part 11 Tap into the expertise of your colleagues and share experiences with those who tackle the same issues and challenges you face. Discussions will take place among groups of 10 participants and are sure to generate information you can use immediately on the job.
For more information visit the PDA website

August 9, 2000

New Publication: 21 CFR Part 11: Long term archiving and ready retrieval

The fourth installment of the series outlines the basis for long term archiving and retrieving electronic records. This article explains which type of data should be stored: raw data, processed data and meta-data. Recommendations are given on selecting storage media and software to ensure not only long term archiving but also 'ready' retrieval for data reprocessing. The requirement can be best achieved by copying the records to new media every couple of years and by migrating data to new systems in a controlled manner.
Download draft version from LabCompliance User Club or order an electronic copy through e-mail.

August 9, 2000

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has posted the draft of the new Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients on the internet: as HTML or PDF files. The draft has been issued in 7/2000 and posted on 8/1/2000. Readers are encouraged to make comments on this draft guidance.