Labcompliance News, March 2008

22 New SOPs from Labcompliance

FDA and ISO 17025 require various routine activities to follow written procedures. Healthcare professionals typically use Standard Operating Procedures (SOPs) to address this. Labcompliance has been offering examples SOPs that help user firms to get started or to confirm their SOPs with external resources. Now we have added 22 more SOPs. In the meantime over 100 example SOPs from help to develop and maintain your own SOPs. They help you to comply with FDA and equivalent international regulations: GLP, GCP, GMP, Part11, PIC/S and with ISO 17025. For a complete list and ordering, click here.

USP <1058> on Analytical Instrument Qualification (AIQ) is Coming

USP has just published a new and most likely final draft before the official release. USP explains the need for general chapter in the introduction: "Competing opinions exist regarding instrument qualification. This chapter provides a scientific approach to AIQ and considers AIQ as one of the major component required for generating reliable and consistent data". The current draft is more clear than previous versions. For example, it states that for group A instruments manufacturer specification of basic functionality is accepted as user requirements and conformance with user requirements may be verified and documented through visual observation of its operation. Attend the Labcompliance audio seminar to learn more about this last draft and get SOPs that help to allocate your equipment to different groups, and to define procedures and qualification deliverables for each group. For more information and ordering, click here.

FDA Publishes a Data Base with Acronyms and Abbreviations

Having a common definition and understanding on acronyms and abbreviations is important for good internal and external communications. This is especially important in the regulated world to avoid any misunderstanding. To avoid any confusion the FDA has developed and published a data base with acronyms and abbreviations database related to Food and Drug Administration (FDA) activities. The emphasis is on scientific, regulatory, government agency, and computer application terms. The database includes some FDA organizational and program acronyms. For more information visit the Web page "FDA Acronyms." The data base can be downloaded as a zip file. The FDA encourage visitors to submit suggestions for acronyms and abbreviations to include in the list.

Revised GMP Annex 1 of the EU GMP Guide Now Available

The revision of the Annex about the Manufacture of Sterile Medicinal Products was necessary in particular to align the classification table for environmental cleanliness of clean rooms with ISO standards. Two public consultations took place in preparation of this new revision. The revised Annex 1 provides supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products. The guidance has been updated in four main areas:
• Classification table for environmental cleanliness of clean rooms, and associated text
• Guidance on media simulations
• Guidance on bioburden monitoring
• Guidance on capping of freeze-dried vials

The new Annex should be implemented by March 01, 2009 except for the provisions on capping of freeze-dried vials, which should be implemented by March 01, 2010. The new Annex can be downloaded from the EUDRALEX website.

20+ Recent FDA Warning Letters Related to CSV and Electronic Records

After there were almost no FDA warning letters related to computer validation and electronic records from 2003-2006, this has changed almost dramatically in 2007and 2008. In 2007 there were at least 15 such warnings and so far in 2008 at least 4. The increased inspection focus on computerized data and enforcement has been announced in FDA's Compliance Update by Edwin Rivera, FDA's chief of the preapproval inspection program. The presentation was entitled: Data Integrity and Fraud - Another Looming Crisis? Labcompliance has analyzed the warning letters. The results, the conclusions and recommendations to avoid computer related deviations will be presented in an audio seminar. Extensive reference materials such as checklists and SOPs will help to effectively implement the recommendations. The handout also includes the Powerpoint file of Edwin Rivera's presentation and copies of the warning letters. For more information and ordering the seminar, click here.

No Validation of CAPA Effectiveness Draws FDA Warning Letter

The FDA not only expects to have corrective and preventive action plans for nonconforming products and processes in place, the effectiveness of the plans should also be verified. This became obvious from a warning letter with a statement that the company failed to establish and maintain procedures for verifying and validating the corrective and preventive action. Moreover the company failed to implement adequate procedures to ensure the quality of incoming products and to evaluate suppliers, contractors and consultants The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 196).

ICH Q9 Implemented in EU GMP Guide as Annex 20

The ICH Q9 guideline as such has been implemented with the new Annex 20. The new Annex is not intended, however, to create any new regulatory expectations; but rather provides an inventory of internationally acknowledged risk management methods and tools together with a list of potential applications at the discretion of manufacturers. The new Annex can be downloaded from the EUDRALEX website.

New Audio Seminars - Updated Schedule

Understanding the New USP <1058> for Analytical Instrument Qualification
With SOPs and Case Studies for Easy Implementation
March 27, 2008
Learning from Recent FDA Warning Letters Related to Computer Validation
and Part 11
With Clear Recommendations for Corrective and Preventive Actions
Thursday, April 3, 2008
Selection and Use of (Certified) Reference Material
Strategies for FDA/ISO 17025 Compliance and Tools for Implementation
Tuesday, April 15, 2008
Sampling and Sample Handling in Laboratories (195)
Strategies for FDA and ISO 17025 Compliance and Tools for Implementation
May 20, 2008
Development and Validation of Stability Indicating Methods (196)
Planning - Design - Conduct - Documentation
May 29, 2008
Contingency and Disaster Recovery Planning for Computer Systems (197)
To Ensure Business Continuity and Compliance
June 12, 2008
Writing Effective SOPs For Regulatory Compliance
Content, format, approval, training and distribution.
Thursday, June 26, 2008

Conferences

Baltimore, April 29 - May 2, 2008
Computer System Validation in FDA Regulated Industries
With Ludwig Huber's analysis of 20 recent computer related Warning Letters
IVT, www.computervalidationevent.com
Baltimore, April 29 - May 2, 2008
Laboratory Compliance with Over 20 case studies
With Ludwig Huber's presentation and workshops on USP 1058 and updated 621
IVT www.labweekevent.com