清洁验证备忘录

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2015 MEMOS

December 2015 Special Cases in Determining "Visually Clean"

November 2015 Only Read This if Applicable

October 2015 Comparing Swab and Rinse Results

September 2015 Duration Specific Health-based Limit Values

August 2015 Route Specific Health-based Limit Values

July 2015 Significance of GRAS

June 2015 What's in Annex 15?

May 2015 EMA on Limits for Shared Facilities-Part 3

April 2015 EMA on Limits for Shared Facilities-Part 2

March 2015 EMA on Limits for Shared Facilities-Part 1

February 2015 What's a Potent Active?

January 2015 Regulatory Status of "Visually Clean Alone"

补充内容 (2015-12-25 09:39):
2010-2015年清单：http://www.cleaningvalidation.com/files/109422356.pdf

冷血无情

似乎东西很好，但是，文盲，路过

罗伊鲱

Cleaning Validation － FDA Basic Drug School
Destin A. LeBlanc，清洁验证专家（给FDA上课的？）
http://www.globallab.com.br/down ... fda_2004_oct_bw.pdf
http://cleaningvalidation.com/St ... %20PDF/June2012.pdf
2012的与2004的基本相同，只多了一页。

EMA网上有其对附录15草案清洁验证部分的评论（值得一读）：
http://ec.europa.eu/health/files/gmp/2015-05_pc_an15/leblanc.pdf

补充内容 (2015-12-24 18:05):
http://cleaningvalidation.com/Store/FDA-DrugSchool.aspx

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专家简历：http://cleaningvalidation.com/Qualifications/CurrVitae.aspx

Curriculum Vitae
Destin A. LeBlanc
Cleaning Validation Technologies
2932 Dayton Drive
Winter Haven, FL 33884
Phone:  863-662-5315
Email: destin@cleaningvalidation.com

Work Experience - Education - Personal Development

Destin LeBlanc has over thirty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last twenty-five years of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing. These include years with STERIS Corporation at their Cleaning and Microbial Control Technology Center in St. Louis, and with Calgon Vestal as part of Merck & Co., Inc. and then as part of Bristol-Myers Squibb. At the end of 2000 he went into full time consulting as Cleaning Validation Technologies.

Since 1990, he has specialized in pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He has worked with both large and small pharmaceutical companies on various aspects of cleaning and cleaning validation. He brings a unique perspective because of his expertise in effective design of cleaning processes as well as validation of those processes.

He was co-chair of a PDA task force to prepare Technical Report #49, “Points to Consider for Biotechnology Cleaning Validation” and was the chair of a PDA task force to revise and update Technical Report #29, “Points to Consider for Cleaning Validation”

Awards

    2006 PDA Distinguished Editor/Author Award
    2013 Kenneth G. Chapman Lifetime Achievement Award from the Institute of Validation Technology.

He has assisted companies with:

    Review of cleaning SOPs
    Review of cleaning validation protocols
    Development of cleaning processes
    Establishment of residue limits
    Selection and validation of analytical methods
    Selection of sampling methods
    Troubleshooting cleaning problem
    Selection of maintenance cleaning procedures
    Implementation of derouging and passivation procedures

He has been involved in specific training for clients and for the FDA in the following subjects:

    Cleaning technologies
    Cleaning validation concepts and practice
    Regulatory aspects of cleaning validation
    Cleaning methods
    Analytical and sampling methods
    Monitoring of cleaning
    Derouging of process equipment
    Passivation of process equipment
    Microbial control in cleaning validation


WORK EXPERIENCE
1/01 to present

Cleaning Validation Technologies Winter Haven, FL
Provide consulting service on cleaning and cleaning validation.
8/80 to 12/00

STERIS / Calgon Vestal St. Louis, MO
This was actually one continuous work experience, except that at various times STERIS, Bristol-Myers Squibb, Merck, Chemed, and W.R. Grace owned the company I worked for. Various titles and responsibilities were:

    Vice President, Scientific Technical Support (9/97 to 12/00) -- Provide overall leadership for four technical support groups (cleaning and microbial control, gamma contract sterilization, ethylene oxide contract sterilization, and sterilization products) for pharmaceutical and medical device industries. Provide leadership for company in technical expertise in cleaning technologies and cleaning validation for pharmaceutical manufacturing.
    Vice President, Quality, Regulatory and Technical Support (4/97 to 8/97) -- Provided leadership of various departments in business unit transition to new ownership.
    Director of Technology (4/95 to 3/97) -- Provided technical service, technology licensing, and R&D liaison for the Contamination Control Group.
    Director, Business Development and Strategic Planning (6/93 to 3/95) -- Developed plans and licensing opportunities to move company into dermatological markets.
    Director, Technical Services (1/93 to 5/93) -- Directed technical services in Healthcare and Contamination Control markets during company reorganization.
    Technical Director, Chemical Technologies Group (6/90 to 12/92) -- Directed new product development and technical service for business group, including Contamination Control.
    Manager, Healthcare Technology (8/87 to 5/90) -- Directed new product development and technical service for Healthcare Group
    Manager, Product Development (6/87 to 7/87) -- Directed new product development for Calgon Vestal Laboratories for both Healthcare and Chemical Technologies groups.
    Director, Product Development (8/80 to 5/87) -- Directed new product development for Vestal Laboratories in areas of infection control and maintenance specialties.

3/77 to 8/80

Harshaw Chemical Company Beachwood, OH

    Group Leader, Textile and Paper Applications -- Directed applications development of inorganic antimony chemicals for flame-retardant applications.

1/72 to 3/77

LeBlanc Research Corp. East Greenwich, RI

    Laboratory Supervisor -- Directed applied research and development on flame retardant textile finishes. Supervised environmental and routine clinical analyses.


EDUCATION
1965-1969

University of Michigan
Department of Chemistry
B.S. with High Distinction (1969)
1969-1972

University of Iowa
Department of Communications
M.A. in Radio, TV, Film (1972)

PERSONAL DEVELOPMENT

    Kepner-Tregoe Problem Solving and Decision Making
    Situational Leadership
    Harvard Negotiations Skills Training
    Merck Advanced Management I, II, and III
    Targeted Selection
    Influence Management
    International Creativity Forum

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More About Destin
Frequently asked questions:

    Why do you include so much useful information on your web site? I thought consultants were supposed to charge for information!
    Can you explain your master’s degree in communications? Isn’t that a bit unusual for a technical consultant?
    Why don’t you do cleaning validation for the electronics/semiconductor industry?
    Any recommendations for someone considering becoming a consultant with a focus on cleaning validation?

    Why do you include so much useful information on your web site? I thought consultants were supposed to charge for information!

    Much of the information (other than the Cleaning Memos) is information that you could get elsewhere on the web, albeit with a lot more work. I try to provide information on basic concepts and practices to help you better appreciate what really is involved in a cleaning validation program. I am relying on the fact that at least a certain percentage of you benefiting from this web site will have more complex issues or pressing needs, such that a higher level of expertise is needed. When that happens, I’d like to be considered as a consultant.
    Can you explain your master’s degree in communications? Isn’t that a bit unusual for a technical consultant?

    Well, it’s not a simple explanation. When I was in college, I thought I wanted to teach at the university level. Halfway through my undergraduate degree in Chemistry, I decided that, although I liked to teach, I wasn’t sure academic research was for me. My interests began to shift to the academic study of Film – and the production of student film projects. At that time I was what was called a “film freak”. I was accepted into the master’s program at the University of Iowa with a teaching assistantship. My emphasis was actually Film Studies rather than Communications per se (although the Film Department was within the Communications Department). Some people attribute my speaking skills to this degree work. However, it was actually training I received from my father when I worked for him in the early 70’s that developed my speaking skills. I think my success is due to this unusual degree and job experience combination. Searching for knowledge in a non-technical discipline has significantly broadened my perspective on approaches to problem solving and, thereby, provided innovative approaches to helping customers solve even such mundane things as more effective and efficient cleaning.
    Why don’t you do cleaning validation for the electronics/semiconductor industry?

    The electronics/semiconductor industry is sufficiently different from the pharmaceutical/medical device industry such that it is difficult (at least for me) to maintain sufficient expertise in both to adequately serve clients. One example of the difference is that cleaning in the medical area is driven by safety and regulatory concerns, while cleaning in the electronics/semiconductor industry is driven by production efficiency. Therefore, my focus will stay with pharmaceutical and medical device cleaning and cleaning validation.
    Any recommendations for someone considering becoming a consultant with a focus on cleaning validation?

    There are several considerations:
        Get some experience with a variety of companies. There is no one way to perform cleaning validation, and having the experience of different approaches to the same issue can make you more valuable as you have to deal with a new situation (which is what each consulting job involves).
        Read everything that is out there on cleaning validation, as well as related subjects (such as quality risk management). Yes, a lot of it is repetitive, but you may be able to pick up new variations, or you might be able to pick up pitfalls to watch out for.
        Publish regularly. I know this can be difficult in a corporate environment, but it gets your name out in print. When you write, don’t follow the traditional guidelines of writing scientific papers in the third person. I’ve benefited (I think) from reading and trying to put into practice an old book, How to write, speak and think more effectively, by Rudolf Flesch (who was not a native English speaker, but who developed many of the formulas for “readability”).
        In any situation, try to understand the other person's objectives, and what his/her constraints might be. This can certainly help you design a better approach for them.
        Luck may have something to do with it. When I was considering venturing out as a consultant, I was told by several people that I would have to offer cleaning validation and “something else”, such as process validation; that I probably would not be able to support myself with just cleaning validation consulting. Well, I guess this was told to other people, because I am one of the few people who focuses exclusively (at a relatively high level) on cleaning validation. I’m fortunate that perhaps others were discouraged from doing this, because I have never been at a loss for work.
        Give something away. My web site is an example of that. Part of my strategy was to give away free stuff so that when people had a paying job, I would be at or near the top of their list. I think it has worked. Finally, do an excellent job in your current position. Don’t just see it as springboard or preparation for being a consultant. This is the right thing to do. And besides, you might find that you enjoy the corporate world after all.

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RELEVANT RISK-MaPP DOCUMENTS

This website contains a number of documents written by Destin A. LeBlanc that are critical of certain aspects of and statements in the Risk-MaPP document. Note that Mr. LeBlanc’s main issue is not with setting limits for highly hazardous actives based on a toxicological evaluation, but rather statements in Risk-MaPP that conventional methods, such as 0.001 of a dose, are not science-based and are arbitrary when used for any actives, including those that are not highly hazardous.

To view pdf files of documents by Mr. LeBlanc critiquing Risk-MaPP, click on the links below. Note also included are documents related to EMA’s PDE version of health-based limits. The documents are listed in chronological order except for item #11.

1. Slides from Webinar “Are We Setting Limits Correctly?”, August 19, 2008. Note that this is actually a critique of a presentation by Andy Walsh, a Risk-MaPP author, on his presentation at a June 2008 ISPE meeting, which was before Risk-MaPP was officially released in September 2010.

2. Cleaning Memo of October 2008 entitled “Are We Setting Limits Correctly?” This is similar to the webinar critique.

3. Cleaning Memo of May 2009, entitled “The Science Behind Limits” discusses what we mean when we say something is “scientific”. This is relevant because one of the main assertions in Risk-MaPP about conventional ways of setting limits is that those conventional ways are “not scientifically justified”.

4. Cleaning Memo of November 2010, entitled “A Critique of Cleaning Validation Issues in ISPE’s Risk-MaPP”. This was based on my attendance at the Risk-MaPP launch meeting in Washington, DC in September 2010.

5. Cleaning Memo of February 2011 entitled “More on ISPE’s Risk-MaPP”.

6. News Release by Cleaning Validation Technologies of March 28, 2011, entitled “Cleaning Validation Expert Challenges ISPE Risk-MaPP Report”.

7. Cleaning Memo Addendum of June 2011, entitled “Where Risk-MaPP Got it Wrong”.

8. Cleaning Memo of December 2011, entitled “The Good, Bad and Inexplicable of Risk-MaPP”.

9. Cleaning Memo of March 2012, entitled "How Are ADE’s Determined for Non-Highly Hazardous Actives?"

10. Cleaning Memo Addendum of October 2012, entitled “Another Critique of Risk-MaPP”
11. PharmaWeb exchange in 2002 [size=+0]between Destin LeBlanc and Andy Walsh on the question of limits: This sheds some light on the possible origin of certain concepts in Risk-MaPP. This also includes a reply made by Destin LeBlanc that was made outside the PharmWeb site.

12. Cleaning Memo of February 2013, “Does Risk-MaPP Offer More Patient Protection?”

13. Cleaning Memo of June 2013, “Are Health-Based Limits Enough?”

14. Cleaning Memo of November 2013, “Comments on the EMA Guideline on Dedicated Facilities”.

15. Cleaning Memo of December 2013, “A Way Forward for “Health-based” Limits”.

16. Cleaning Memo of January 2014, “Setting Limits for Cleaning Agents”.

17. Cleaning Memo of May 2014-Addendum - "Shortcomings of ADE/PDE Values for Cleaning Validation"

chen5385973

这.......英文懒得看，麻烦

罗伊鲱

RELEVANT RISK-MaPP & HEALTH-BASED LIMITS DOCUMENTS
http://www.cleaningvalidation.com/risk-mapp.html

补充内容 (2022-1-16 00:47):
http://1821530.sites.myregisteredsite.com/2021-memos.html

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谢谢分享！！

小金库

谢谢分享。