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Labcompliance News, February 2005

February 24, 2005

FDA Inspection Package Version 2 Released

An FDA inspection can be a nightmare that costs your company money, time and reputation, or it can be an opportunity to make a long lasting good impression at the FDA and to improve your quality systems. Single and multiple 483 Inspectional Observations and Warning Letters can be a disaster for a company. Bad reputation for the company and employees, delay of new product approvals, import alters, products recalls, multi-million $ fees, seizures and consent degrees can be the consequence if not followed up correctly in time. However, 483's and warning letters can be avoided. Labcompliance has developed a new release of it's popular FDA Inspection Package. It includes more SOPs, an updated primer, most recent FDA guidelines and the complete audio seminar presentation on FDA inspections. It is ideally suited to prepare your department, your site, and your entire organization for FDA inspections in the U.S. and international countries. For more information and ordering click here.

February 24, 2005

Links to FDA Guidelines for Computer Validation

Software and computer systems used in FDA regulated environments should be well controlled and validated. While there is not much detail in FDA regulations the agency has developed many guidance documents. The most recent one is FDA's industry guide on "Using Computers in clinical Trials", But also some older ones from the 80's and 90's are quite useful because the fundamentals of computer validation did not change that much. Labcompliance has developed a special site with short abstract and links to 17 FDA documents related to using computers. Click here to visit the site.

February 24, 2005

New FDA Guidance on Impurities in Drug Substances

On January 28, FDA published the "Guidance for Industry: Guidance for Industry ANDAs: Impurities in Drug Substances". This guidance provides revised recommendations on what chemistry, manufacturing and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting
Original abbreviated new drug applications (ANDAs)
Drug master files (DMFs) including type II DMFs
ANDA supplements for changes in drug substance synthesis or process

The guidance also provides recommendations for establishing acceptance criteria for impurities in drug substances. The guidance, when finalized, will replace a 1999 guidance of the same name.

February 24, 2005

Inadequate Investigation on Contamination Raises FDA's Concern

During a recent inspection FDA investigators determined lack of procedures and policies and inadequate approach to investigating sources of contamination. The letter stated. "The manner in which (company name) investigated the contamination problem in this study causes FDA to have concerns with the validity of other bioequivalence data generated by (company name)." The letter furtherer stated: "Your approach to investigating sources of contamination in bioequivalence studies is inadequate and has resulted in the submission of invalid data to the agency. You should have conducted a systematic and thorough evaluation to identify and correct the source of contamination when it was first observed", and it concluded with further warnings: "Because of these concerns, the agency intends to determine on a case-by-case basis what additional steps may be necessary to assure the accuracy and validity of the analytical method for bioequivalence data. Such steps could include, amongst other things, additional inspections, third-party audits, and rejection of data where circumstances warrant." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Inadequate failure investigations, inadequate handling of out-of-specifications (OOS) situations and missing corrective and preventive inspection actions have been amongst the most frequently cited deviations in recent FDA Warning Letters. Learn in an upcoming Labcompliance audio seminar how to avoid such warning letters.

February 24, 2005

Recent FDA Warning Letter for Missing Software Revalidation Protocols

In a warning letter from September 2004 the FDA cited a firm for not providing revalidation protocols: Your response (to Form FDA 483, List of Inspectional Observations) indicates that the computer software was initially validated in April 2001 and that it was going to be revalidated in May 2004. You also included the validation report of the software used for maintenance of the complaint. However, the adequacy of the challenges to the computer systems cannot be fully assessed since the validation protocols were not provided. Other deviations include: No or inadequate failure investigation to determine the route cause of the failure, failure to assure that test procedures are scientifically sound, failure to reject drug products to meet established standards or specification, no or inadequate scientifically sound specifications, standards, sampling plans, inadequate stability test program, no or inadequate cleaning validation. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts.

February 24, 2005


Labcompliance Seminars: An Overwhelming Success Story

A little bit more than a year ago we have started with the audio seminars. At that time we had some concerns whether the seminar series would be a successful. There were many companies offering this service. A year later we can report a big success. So far we did run more than 20 such seminars. They were all well attended. Delegates came from and more than 50 companies located in more than 20 countries. Most attendees did give feedback which we used to constantly improve the seminars. The approach is well accepted which is: use the one hour seminar to introduce the topic, present strategies and answer questions, and offer reference material for easy implementation The story does not end here: we will continue the series and started to provide even more convenience: question and answers available on the seminar website, written scripts of selected seminars and the ability to download the recorded sessions are just some of them. For seminar topics of past and future seminars click here.