Labcompliance News, October 2008

FDA to Open an Office in China before the End of This Year

Several times the FDA has announced to open offices outside the United States. Now this gets very close. FDA Commissioner Andrew von Eschenbach on October 16 has announced that the first office will already be opened in China before the end of this year
FDA officials said the plan would cost about $30 million in its first year, primarily to set up the offices and hire new staffers, including foreign nationals who would report to the agency. According to Mr. Eschenbach other target countries and regions for FDA offices are India, Latin America and the Middle East. This is part of the FDA Globalization Act of 2008 with the objective to assure the safety of imports from the developing world. To get information on the Globalization Act and how it impacts domestic and international medical device, food, drug and API manufacturers, click here. The full article has been posted on Oct 17 by Bioethics International.

FDA Recommendations for Product-Specific Bioequivalence

The Food and Drug Administration (FDA) announced in a Federal Register notice of September 5, 2008, the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

FDA Expects to Investigate OOS Results Obtained During Computer Validation

FDA and other regulatory agencies expect to initiate an investigation if a deviation from specifications is found during retrospective validation or requalification of instruments and computer systems. This is stated in ICH Q7A GMP Guide for Active Pharmaceutical Ingredients: "Deviations from approved standards of calibration on critical instruments should be investigated to determine if these could have had an impact on the quality of API(s) manufactured". This also became obvious during an FDA inspection of a device company. The related deviation in the warning reads: "Computer Numerical Control (CNC) Machine #C-4 had out of specification results during operational qualification conducted during validation. These out of specification results were not investigated or addressed in the validation report." In addition, the company failed to verify the effectiveness of CAPA, to evaluate suppliers and contractors, and  to implement management procedures The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 207).  For information on compliant retrospective validation, click here.

FDA Publishes SOP for Handling Regulatory Electronic Communications

The purpose of this SOP is to describe the policies and procedures for the Center for Biologics Evaluation and Research (CBER) staff on the handling of regulatory electronic messages (emails). Regulatory emails may be either internal communications or messages received from or sent to sponsors/applicants. The SOP is available on the FDA website

Missing Verification of CAPA Effectiveness Cited in FDA Warning Letter

 Any good SOP on OOS and CAPA should not only require an investigation, a root cause analysis and corrective and preventive action plans, but the effectiveness of CAPA should be formally verified. OOS and CAPA are amongst the most inspected item and part of it is verification of CAPA. Frequently companies have procedures for CAPA but without verification. Here is an example from  recent FDA Warning Letter: "Failure to establish and maintain procedures for implementing corrective and preventive action to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely effect the finished device. Specifically, your ...does  not indicate the results of the validation or verification testing and any re-evaluation of the risk analysis to ensure the effectiveness of the corrective action.". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 208).  To learn everything about FDA compliant OOS investigations and CAPA including correct verification of efficiency, click here

Amendment of FDA Regulations Regarding Changes to NDA, BLA and PMA

The Food and Drug Administration announced in a Federal Register notice of August 22, 2008, that the agency is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). Affected regulations are 21 CFR Parts 314, 601, and 814. This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.

Warning Letters and Import Alert for Foreign Drug Manufacturer

The Food and Drug Administration (FDA) announced the issue of two Warning Letters to a drug manufacturer. Because of the extent and nature of the violations, FDA also issued an Import Alert for generic drugs produced at two plants, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at the inspected facilities and offered for import into the United States. As part of the Globalization Act 2008 the FDA plans to significantly increase the number of foreign inspections.

FDA Published its Fourth Issue of the Drug Safety Newsletter

This publication provides post-marketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.

New ICH Guidance: Dose Selection for Carcinogenicity Studies

This 13 pages guidance provides recommendations for dose selection for carcinogenicity studies of human pharmaceuticals. The guidance is intended to aid sponsors in selecting appropriate doses for rodent carcinogenicity studies. FDA first issued the ICH guidance S1C Dose Selection for Carcinogenicity Studies of Pharmaceuticals in October 1994 and the addendum to the parent guidance S1C(R) Addition of a Limit Dose and Related Notes in July 1997. In November 2005, ICH incorporated the addendum to the parent guidance (S1C(R1)). In March 2008, ICH further revised the guidance (S1C(R2)).3 This new revised guidance includes the changes made by ICH in November 2005 and March 2008. The guidance can be downloaded from the FDA website

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP: Conducting Management Reviews. To download your free copy, go to the ISO 17025 Tutorial, scroll down and click on the corresponding ICON on the left (offer expires on Nov 1). Labcompliance offers more than 100 SOPs. For titles and ordering, click here.

 

2 Day Interactive Workshop by Dr. Ludwig Huber

1. ECHO Consulting Group
   Computer System Validation and Part 11 Compliance for (Bio)Pharmaceutical and Device Industry
   Jan. 20/21, 2009 San Juan, PR, USA
   Learning through examples: 50% of the time will be dedicated to case studies

New Audio Seminars - Updated Schedule

1. Validation of Existing/Legacy Systems (207)
   Regulatory requirements and tools for implementation
   Oct 23, 2008
2. Bioanalytical Method Validation  (208)
   Conduct and Document for Efficiency and FDA and EMEA compliance
   Nov 04, 2008
3. Raw Data in FDA Regulated Environments (209)
   FDA/EU compliant recording, maintenance and archiving
   Nov 13, 2008
4. Effective Gap Analysis for ISO 17025 (210)5
   With Practical Tools for Easy Implementation
   December 4, 2008

Conferences

1. Conference Calendar Echo Consulting

New or Updated Sites

• ISO 17025 Tutorial
• Audio Seminar Homepage

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