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Latest Compliance Update for Computer Systems

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IT Infrastructure and Network Qualification
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Traceability in Chemical Analysis
With strategies and tools for ISO 17025 and FDA Compliance
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Effective Verification of Compendial Methods
Understanding USP and FDA Requirements and get Tools for Implementation
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Auditing Laboratories for FDA and ISO 17025 Compliance
Preparation - conduct - follow up - documentation
Recorded, available on demand

 

Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
Comply with the FDA and international guidances
Recorded, available on demand

 

Validation and Use of Excel® Spreadsheets in Regulated Environments
With FDA's
Dennis Cantellops

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Labcompliance News, April 2009

FDA Releases Final ICH Guidance Q10

The US Food and Drug Administration has released ICH Q10 'pharmaceutical quality Systems' as final FDA guidance. This guidance applies to the systems supporting the development and manufacture of pharmaceutical drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including biotechnology and biological products, throughout the product lifecycle. ICH Q10 describes one comprehensive model for an effective pharmaceutical quality system that is based on International Organization for Standardization (ISO) quality concepts, includes applicable good manufacturing practice (GMP) regulations, and complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management.” ICH Q10 is not intended to create any new expectations beyond current regulatory requirements. Consequently, the content of ICH Q10 that is additional to current regional GMP requirements is optional. The Guidance can be downloaded from the FDA website.

Brazilian New GMP's Rely on EU Annex 11 for Regulating Computerized Systems

In January this year ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian equivalent of the US FDA, published a new draft GMP regulation with several Annexes. Annex 5 regulates the use of computers in GMP environments. It  looks like an abbreviated version of the new Annex 11 to the European GMPs that has  been published as draft about a year ago. 18 out of the 19 chapters in Annex 11 have equivalent chapters in ANVISA's Annex 5. Chapters include risk management, personnel, validation, system documentation, quality assurance of software development, data processing, user testing, security, audit trails and others. Most interesting is a statement that for complex systems, e.g., databases, chromatography, process control) inspectors should be able to access and study electronic system records of paper printouts. Annex 11 covers all aspects of using computers and with FDA's ongoing delay of the new Part11, it could become the global GMP standard for using computers. To get copies of the ANVISA document in English, to learn everything about the new Annex 11 and to get 10+ best practices tools for implementation, click here

New FDA Guidance on Pharmacopoeial Texts - Sterility Test

The Food and Drug Administration announced in a Federal Register notice of February 17, 2009, the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 8: Sterility Test General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Sterility Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance can be downloaded from the FDA website.

'Advice' from the FDA on Part 11 in an Establishment Inspection Report

FDA establishment inspection reports are quite useful because inspectors provide an objective inspection protocol. Most interesting is information on what has been inspected, what the inspector's questions have been and how the regulated company did comply. An example is a cGMP inspection report of a mammalian cell culture contract manufacturing facility. Inspected areas and systems included quality, equipment, materials, production, packaging and labeling and laboratory controls.  No FDA-483 was issued but in the management meeting at the end inspectors gave recommendations for improvements related to Part 11, electronic records, computer validation, cleaning verification, media fills, and environmental monitoring.  For example: "Issues pertaining to electronic records and signatures related to the firm's computer systems should be resolved in compliance with 21 CFR Part 11. Activities and assessments including upgrades to the current system should be completed with high priority. Drawings should be controlled. e.g., stamped signature and date"and 'More specific diagrams or locations for environmental monitoring sampling plans should be provided" The 14 page EIR with more recommendations can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 216). 

FDA Presentation: Writing An Effective 483 Response

Anita Richardson, Associate Director for Policy, at the FDA Office of Compliance & Biologics Quality, gave a presentation at a pharma conference on "Writing An Effective 483 Response". Ms. Richardson covered three areas: 1) Regulatory framework and FDA policies and procedures for the FDA 483; 2) Reasons for submitting a well-reasoned, complete, and timely 483 response; and 3) Eight suggestions for an effective 483 response. It became clear that with well written timely response could possibly mitigate an FDA compliance decision for further action, e.g. untitled letter, Warning Letter. The warning letter can be downloaded from the Labcompliance Usersclub. Scroll down to G-229. For information and registration to the Usersclub, click here.  

"Computer System not Maintained in Validated State" Cited in FDA Warning Letter

 Computerized systems should be maintained in validated state and reviewed. This became obvious in a recent FDA warning letter.  The letter reads: "Your firm failed to maintain computerized systems in a validated state. The inspection team noted that this automated system, containing formulas and recipes for buffers was programmed in 1999 and has not been reviewed or updated. We are concerned that other discrepancies in other values may exist. Please comment on how you will assure all values programmed into the automated system, and other automated systems, are consistent with current master batch records." In addition the letter mentioned other deviations, e.g., "No adequate monitoring of bioburden" and "Written procedures for equipment maintenance not followed"  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 215).  To learn everything risk analysis and management, and to receive a risk management master plan and SOPs, click here

PIC/S Publishes Inspection Guide for APIs

The guide, officially called AIDE MOMOIRE,should provide training and guidance to GMP Inspectors not specialized in the inspection of API manufacturers. The guide should also contribute  to a harmonized approach for inspections of API manufacturers between the different PIC/S Members. While this 24 page document has been developed for PIS/S inspectors is also a good tool for API manufacturers to be used in preparation for internal audits and for pharmaceutical companies for auditing API suppliers. The guide can be downloaded from the PIC/S website.

Brazil is Becoming a Top Emerging Pharmaceutical Market

Pharmaceutical companies are advised to pay attention to Brazil. Stable economics and growing healthcare concerns make Brazil one of the top emerging pharmaceutical market, In 2008, the Brazilian pharmaceutical market was estimated to reach US$ 14.9 billion, 34% of Latin America, jumping 23% from 2007. The market is controlled by the National Health Surveillance Agency (ANVISA), created in 1999, which is the equivalent of the US FDA.  ANIVISA just published a modern draft GMP with seven detailed Annexes for public review.  The US Pharmacopeia has recognized the value of the Brazilian market by opening its fourth overseas location (after Switzerland, India and China) in Sao Paulo in August 2008. The full article has been published by Pharmaceutical Commerce and as of April 2009 is available on the publishers website. Copyright rests with the publisher.

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: Archiving and Retrieval of GMP Data and other Documents.To download your free copy, go to the  seminar page Raw Data in FDA Regulated Environments (209) , Scroll down and click on the corresponding ICON on the left (offer expires on May 12, 2009). Labcompliance offers more than 100 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here

 New Audio Seminar Schedule

  1. Traceability in Chemical Analysis
    With strategies and tools for ISO 17025 and FDA Compliance
    Recorded, available on demand
  2. Effective Verification of Compendial Methods
    Understanding USP and FDA Requirements and get Tools for Implementation
    Recorded, available on demand
  3. Auditing Laboratories for FDA and ISO 17025 Compliance
    Preparation - conduct - follow up - documentation
    Recorded, available on demand
  4. Managing Out of Trend Results in Pharmaceutical Manufacturing and Quality Control
    Comply with the FDA and international guidances
    Recorded, available on demand

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