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Labcompliance News, May 1999

May 1, 1999

The Industry's View of 21CFR Part 11

Ken Chapmann, well known as the long year chairman of the the US PMA's Computer System Validation committee and now consultant to the pharmaceutical industry gave a presentation at the IVT conference on 21 CF Part 11. While Ken finds most of the chapters useful he finds three areas inappropriate:
Mandating use of local time-stamping to prevent fraud;
Level and nature of detail specified for electronic data that must be archived; and
Insistence on integrating electronic audit trails directly with electronic records.

Ken collected a lot of inputs from a wide range of industry experts and can be seen as some kind of an industry spokesman. Download Ken's paper from LabCompliance User Club or order an electronic copy through e-mail.

May 1, 1999

More than 500 Validation Seminar Attendees in Japan

More than 500 experts from the pharmaceutical business attended the seminar on "The Validation of Computers and Equipment in Analytical Laboratories" in Tokyo and Osaka, Japan, on April 13 and 15. The seminar was organized by the Japanese Society for Quality Assurance (JSQA) and Yokogawa Analytical Systems (YAN) with foreign guest speakers Paul Lepore, former US FDA inspector and Ludwig Huber, validation expert from Hewlett-Packard. Paul Lepore presented FDA's expectations on the validation of computers. Ludwig Huber presented a practical proposal for implementation. The discussions were mainly focused on FDA's expectations on record keeping when computers are used for the creation, evaluation and archiving of data.

May 1, 1999

New Proficiency Testing Scheme Launched

LGC launched a new proficiency testing (PT) scheme in November 1998 for laboratories concerned with the analysis of soft drinks. The Soft Drinks Analysis Scheme (SODAS) has been developed in cooperation with a number of companies in the soft drinks manufacturing sector. The need for a PT scheme covering soft drinks was identified within the soft drink industry, and LGC were invited to develop a scheme which would deliver the same quality of service as the existing BAPS or DAPS schemes for the alcoholic drinks industry. For further information please contact Steve Evans, SOSA Secretariat at LGC, at sje@lgc.co.uk

May 1, 1999

Guidelines for the In-house Production of Reference Materials

If valid analytical results are to be obtained, it is desirable that analysts use certified reference material (CRMs) as part of their quality system. However, a common experience of routine analytical laboratories is that CRMs are often too expensive for regular day-today use and are not always available in the precise form required by the laboratory. Laboratories therefore find it necessary to prepare their own in-house reference materials for such purpose as instrument calibration, the construction of QC charts and checking the accuracy of particular methods and results. The VAM has published 'Guidelines for the in-house production of reference material'. The guidelines cover such topics as the selection and preparation of materials, providing helpful suggestions as to the issues that should be considered, such as need for drying, stabilization, mixing, grinding and suitable packaging. For a free copy please contact the VAM Help Desk under vam@lgc.co.uk

May 1, 1999

Video on FDA's 21CFR11 industry training available

Did you miss FDA's industry training on Jan 21, 1999. No worry. The conference has been video taped. The video is available in PAL and NTSC format.

May 1, 1999

Detailed question/answers from the FDA on e-sig/records

Detailed question/answers from the FDA on e-sig/records
In response to many questions on 21CFR Part11 the FDA has published most frequently asked questions and answers on the internet.

May 1, 1999

More new links

LabCompliance is rapidly growing, both the number of visitors is going up as well the contents. Every months many links are added. There are too many to mention them individually. This months we have added links to

  • Computer validation

  • electronic signatures

  • regulations/us-fda

  • regulations/us-epa

and others