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Labcompliance News, April 2006

April 18, 2006

36 New Documents in the Labcompliance Users Club

We have added 36 new documents to the Labcompliance UsersClub. They include eight SOPs, four checklists/ templates/examples, two reference papers, eight FDA presentations, three FDA guidance documents and 12 FDA warning letters/483's related to GMP/GLP or GCP. User club members can instantly download the new additions.. To see the list and ordering the users club, click here. With these additions, the UsersClub has >400 documents ready for download.

April 7, 2006

FDA Publishes a Compliance Program Guidance Manual for API Process Inspections

IThis program manual provides guidance for evaluating compliance with CGMP. The guidance states that APIs should be manufactured in conformance with CGMP: "No distinction is made in the Federal Food, Drug, and Cosmetic Act between an API and a finished pharmaceutical in the Act and the failure of either to comply with CGMP constitutes a violation of the Act. The compliance manual also states that "ICH Q7A represents the Food and Drug Administration’s (FDA’s) current thinking on CGMPs for API’s. API and related manufacturing and testing facilities that follow this guidance generally will be considered to comply with the statutory CGMP requirement". The compliance manual is a tremendous help for API manufacturers to prepare for FDA inspections. It can be downloaded from the FDA website.

April 7, 2006

The 4Q Model for Equipment Qualification is Becoming Official

•Analytical instruments should be qualified to demonstrate suitability for their intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters and other inspection reports. Companies are unsure on what exactly to qualify or re-qualify, and what to test and document. The main reason is that unlike for analytical methods there are no clear standards for equipment qualification. This is changing. The USP has developed a draft chapter for analytical instrument qualification (AIQ). When implemented right the chapter also helps to reduce overall qualification costs. Two versions of the draft have been published in USP’s Pharmaceutical Forum in January and August 2005 (USP Pharmaceutical Forum 31(1) and 31(5) resp.

April 7, 2006

Update on FDA’s 21 CFR Part 11 - With Free SOP for Implementation

FDA's Part 11 guidance on scope and applications seems to work very well. However as a guidance can not overwrite a regulation, the regulation it self must be updated. Already in 2003 FDA officials have announced a new release of Part 11. First it was scheduled for the end of 2005, now it has been delayed to Q2 or Q3 in 2006. It seems that the content is final and very much based on the current Part 11 guidance: scope and application, but it takes time to pass all FDA administration. Most likely the concept of risk based controls will be extended to other part 11 requirements and enforcement discretion for legacy system will be replaced by a risk based approach.

April 7, 2006

New FDA Guidance for Submissions Using the eCTD Specifications

This new guidance is one in a series of guidance documents intended to assist applicants making regulatory submissions to the FDA in electronic format using the electronic common technical document (eCTD) specifications. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling. The goals of the guidance are to enhance the receipt, processing, and review of electronic submissions to the FDA. Specifically, this guidance makes recommendations regarding the use of the eCTD backbone files developed through the International Conference on Harmonisation (ICH) to facilitate efficient submission handling. Finally, the guidance harmonizes the organization and formatting of electronic submissions for multiple submission types. .