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

Labcompliance News, July 2002

July 19, 2002

Understanding the "Part 11 Validation Guidance"

One of the characteristics of the validation guidance is that is sets high requirements but often does not say how to implement them. It uses new vocabulary like life testing, regression testing, high load testing but no specific examples. We have developed a document entitled "Understanding the Part 11 Validation Guidance". It not only has the guidance text but gives the expert's interpretation and even more important specific considerations and examples that help to better understand the meaning.

July 04, 2002

M 500$ fine:FDA Sets Clear Sign to Continue Enforcement

After multiple GMP problems since 1998 Schering-Plough signed a consent decree with FDA May 16 and agreed to pay over $500 million in fines. This was the largest ever assessed on an FDA regulated company. The decree affects about more than 100 different prescription and over-the-counter drugs as part of the decree, the company has agreed to suspend manufacturing 73 other products (Ref: Validation Times, May 21, 2002). Schering received at least five warning letters and 483's. User Club members can download five warning letters (D2 to D6)and an 18 page 483 inspectional report (D1). The 483 is quite comprehensive and can almost be used as a checklist in preparation for FDA inspections. For preview and registration, click here

July 03, 2002

Paul Motise: GxP Data on E-Proms Should Comply with Part 11

There is still a perception that records stored on E-Proms are not in the scope of part 11 because they are not 'durable'. The question came up at the IVT ERES conference in Airlington. Paul Motise, a consumer officer at FDA's office of enforcement and one of FDA's leading part 11 voices made it clear that part 11 applies when E-Proms hold GxP related data. "You can have electronic records even if it is not durable" he said. He also recommended to take a look at the Federal Legislation Electronic Signatures Global and National Commerce Act (E-sign Act) . That law defines a record as "Information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form". Labcompliance Users Club
Members can download the presentation, the 'EPROM' section of the Q&A session and the E-sign Act from the part 11 UsersClub website. For preview and registration, click here

July 03, 2002

EMEA Releases Draft Guidance on Stability Testing

The Committee of Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has released a draft guidance on the "Stability Testing of Existing Drug Substances and Related Products". The guideline is an extension of the ICH Q1A (R) guideline on the stability testing of New Drug Substances and Products (CPMP/ICH/2736/00 corr). Comments on the draft guidance are due in August 2002.