Dear Manufacturing, Engineering, and Quality Focus Group Members
We have had an exciting several years as the Manufacturing, Engineering, and Quality Focus Group. We have opened AAPS to the manufacturing, engineering, and quality aspects of pharmaceutical production. We have coordinated programming that is of interest to you. As part of the continued evolution of the part that manufacturing and engineering plays within AAPS, you have been informed that they have decided to create a new section Manufacturing Science and Engineering (MSE). This new section will continue and advance the interests of people like you in the programming offered by AAPS.
As part of the creation of MSE and the leadership needs, a decision has been made to dissolve the Manufacturing, Engineering, and Quality Focus Group. This will correspond with the official creation of the Manufacturing Science and Engineering section which will take place on July 1, 2008. We thank you for your interest and participating in our programs. We also strongly encourage you to remain with AAPS and to join the Manufacturing Science and Engineering section and to continue to enjoy programming of interest to you.
MEQ Leadership
MEQ-FG Mission Statement
To provide leadership in the area of pharmaceutical manufacturing by:
- a forum for discussion across industry and regulatory agencies
on Manufacturing, Engineering, and Quality aspects of
pharmaceutical operations.
- Focusing on issues related to technology transfer of drug
substances and drug products, both within and outside the US.
- Serving as a communication link with other technical
organizations such as ISPE, AIChE, PDA, and NJPhAST.
- Collaborating with AAPS PT section and focus groups, such as
PAT, to identify strategies to implement global regulatory
initiatives such as Quality by Design in pharmaceutical
manufacturing.
- Serving as a platform to promote technical advances in the
fields of pharmaceutical process, equipment, facility, and
quality system design and implementation.
Vision Statement
The AAPS-MEQ Focus Group aims to:
- Facilitate a consensus across industry and regulatory agencies on the approach to implement Q by D in pharmaceutical manufacturing.
- Initiate the process to set up a globally applicable standard / guideline for technology transfer of drug substance and drug product.
- Catalyze innovative plant and equipment design to meet industry needs.
- Catalyze interaction between Development and Manufacturing, Engineering & Quality
- Serve as a conduit to bring technical advances from other industries to pharmaceutical manufacturing and warehouse management.
Goals
- Develop the focus group structure
- Work with PT Section and other sections to develop synergies and remove overlaps
- Create awareness in the industry of this focus group
- Stimulate membership in AAPS
- Identify champions in major companies (already have champions in Forest Labs, Hoffmann-La Roche, Johnson & Johnson, Organon, Pfizer, Sanofi-Aventis, and Wyeth)
- Establish web and listserv sites
The focus group will be allied with the PT Section; however,
Members from other sections such as Biotech, RA,PDD, PPDM,
would also benefit by joining this group.
This Focus Group on MEQ will provide a forum for the interactive
collaborations between the technical personnel involved in the
areas of drug product and drug substance manufacturing,
packaging, materials management, engineering maintenance, plant
design, quality control and quality assurance. The link with
other scientific and public organizations will permit AAPS to
share in creating scientific and business programs and
publications within AAPS, which will address matters of public
interest in these areas. One of the main goals will be to focus
on technology transfer of drug products and drug substances
both within and outside US.
The FG will plan programs such as round table discussions,
symposiums and workshops on the above topics. The FG will serve
as a forum designed to bring equipment manufacturers and
industry experts together to facilitate the design and
development of cutting-edge equipment intended to meet the
changing needs of the industry.
On the Quality Assurance side, the FG will try to hold
discussions between regulatory agencies of the world and
industry aimed at streamlining the quality process and making
the quality process a scientifically based process.
Meetings Minutes
January 23, 2008
June 9, 2005
JOIN THE MANUFACTURING, ENGINEERING, and QUALITY LISTSERVE
To join the Manufacturing, Engineering, and Quality Focus Group Listserv click here.
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