developments with pharmig 2010

Developments with PharmigPharmig

New publications and more

Tim Sandle

Pharmig Reviews No. 1 Current Perspectives on Environmental Monitoring

• Examines current practices in environmental monitoring, including:– Cleaning techniques– Risk assessment to

investigate data deviations– How to set the frequency of

monitoring and locations– The one or two media debate– Validation of methods

£60 for members£85 for non-members

NEW

Pharmig LAL Fact Sheets• A series of Limulus Amoebocyte

Lysate (LAL) laminated Fact Sheets on pyrogen/ endotoxin testing have been produced by the LAL Action Group. The series of 6 LAL fact sheets (as a package) currently available are:– What is LAL/BET?– Calculation of Endotoxon Limits– Medical Devices– Gel Clot Methods– Photometric Methods– Product Validations Quantitative

Methods

£35 for members£60 for non-members

A Guide To Disinfectants and their use in the Pharmaceutical Industry

• A review of standards, regulations and literature

• The foreword by Stephen Monk – MHRA

• Chapters include:– GMP associated with

disinfectants, – Types of disinfectants, – Selection– Validation– Practical use – Biocidal Products Directive.

£60 for members£85 for non-members

Microbiological Control for Non-Sterile Pharmaceuticals

• Jointly produced by Pharmig and the PQG

• Spiral bound• Forward by MHRA• Includes chapters on:

– Roles and Responsibilities– Personnel– Facilities– Cleaning– Laboratories– Monitoring / Risk Assessment– Reporting and Trending

£35 for members£60 for non-members

Newsletter #1• 40 issues to date! • Full colour newsletter sent

to members every quarter.• Each issue includes:

– Technical articles– Regulatory update– Book reviews– Techniques and training– Update on Pharmig courses

and events– Overview by the Pharmig

ChairmanFree to members£25 for non-members

Newsletter #2• Recent newsletters have included:

– Rapid Microbiology Methods: What considerations to review when looking at implementing a RMM and The development of Culture Media for the most testing pharmaceutical test

– Cleanroom Operator Training: An approach for Basic Hygiene– Microbiological Quality of Drug Products after Penetration of

the Container System for Dose Preparation Prior to Patient Administration;

– Microbiological Sterility Testing: Isolator Technology versus Clean Room;

– Microbiological Control of non-sterile products - How much is enough?;

– Biological Indicators for Steam Sterilisation

Website

• The Pharmig website has been re-launched• The site includes:– Publications (including electronic ordering)– Discussion forum– Members only section, including technical articles not

available in the newsletter• Microbial taxonomy• Cleanroom technologies• Risk assessment tools• Preservative testing• A guide to microbiology on the World Wide Web

Website

• Plus:– Job vacancies– Courses and conferences– Membership renewal– Newsletter archive– Pharmaceutical Microbiology MSc– Pharmig action groups– Details about the committee

Pharmaceutical Microbiology Blog

• In December 2009 a discussion blog, edited by Tim Sandle, was launched

• The blog is linked with Pharmig• 500+ positing• 20,000 unique visitors• Archive section, including:– Cleanrooms– Infection control– Regulatory update– Microbiological techniues– Environmental monitoring– Disinfection– Non-sterile testing– Education articles

www.pharmig.blogspot.com

New Media: Facebook and LinkedIn

• Pharmig has pages on Facebook and LinkedIn.– The LinkedIn site is the

most popular with over 350 national and international members

– The LinkedIn site receives updates from the blog and allows for other discussions to take place

Key “Pharmig” for both

Future Publications

• All publications can be ordered on line via: http://www.pharmig.org.uk/Membership/Publications/View-all-products.html

• Pharmig are considering the publication strategy for 2011. Please offer suggestions– Possible publications include:• Sterility Assurance• Current reviews of LAL/ Endotoxin• Pharmaceutical microbiology glossary• Pocket guide to cleanrooms and contamination control

Thank You