How Do "Life Science" Scientific Organizations and Trade Associations Contribute to the Development of Cleanroom Standards?

Introduction to “Life Sciences” Associations

Non-profit, scientific organizations, and trade associations help create standards for research, pharmaceutical, biologic, medical devices, and manufacturing. Consult with these organizations about standards and continuing education and training that you can use to develop standard operating procedures for your cleanroom operation.

U.S. Pharmacopeia (USP)

USP is an independent, scientific non-profit organization focused on building trust in the supply of safe, quality medicines. USP focuses on strengthening the global supply chain so that the medicines people rely on are available when required and are effective. USP was formed in 1820 when 11 physicians came together to take action to protect patients from being harmed by the current inconsistent and poor-quality medical preparations.

The first standards were “recipes” that guided the preparation of medicines. Today, USP “recipes” have evolved to an established set of quality specifications for medicines including analytical tests to be performed to assess quality attributes.

USP Standards

USP Compounding Compendium is the trusted go-to resource for pharmacists and healthcare practitioners. It offers quality assurance for compounding methods, preparations, and overall practices in different healthcare settings. The USP Compounding Compendium provides access to the USP standards and National Formulary (USP-NF), the official compendia of standards for drugs marketed in the U.S. It features more than 40 general chapters, including 795 and 797 for compounding pharmacies and more than 170 compounding monographs along with general notices and other key resources that are most useful in compounding practices.

USP Biologics standards ensure the quality of medication is fundamental to protecting public health, especially as ingredients and products come from all over the world. Biologics such as recombinant therapeutic proteins, vaccines, blood components, tissues, and gene therapies are emerging faster than any other segment of medicine. Biopharmaceutical manufacturers must ensure the purity and quality of the biologics. USP quality standards assist the manufacturer by increasing predictability, reliability and integrity of the global supply chain.

USP has reference standards for dietary supplements and herbal medicines, excipients, pharmaceutical analytical impurities and small molecules. Manufacturers participate in USP Verification Services to ensure the quality of ingredients from different suppliers. The USP Verification Services consist of rigorous cGMP audits focusing on ingredient quality control and manufacturing, process evaluation, and laboratory testing of ingredients for compliance.

Parenteral Drug Association (PDA)

The mission of PDA is to advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients. PDA offers a broad range of conferences and workshops on trending topics, international research initiatives, and hands-on training courses that provide practical information and implementable solutions.

Training courses based on technical reports provide implementable solutions related to current regulatory issues facing the current pharmaceutical manufacturing industry. Courses vary from aseptic processing, quality risk management, root cause investigation for corrective and preventive action, and technology transfer.

International Society for Pharmaceutical Engineering (ISPE)

ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence, and regulatory insights to enhance industry efforts to develop, manufacture, and reliably deliver quality medicines to patients.

ISPE was founded in 1980 to address the practical applications of science and technology in the development of next-generation process technologies and solutions; regulations that impact the licensing of facilities; manufacturing processes and operations; and the sustainability of the supply chain over the product life cycle.

ISPE publishes guidance documents, and technical and educational programs include implementing Pharma 4.0-based manufacturing concepts.

Trade Shows & Educational Events

The following events offer educational and training opportunities.

INTERPHEX

Interphex is the leading global event that fuses industry innovation with an expert-led technical conference. It’s where the newest ideas are shared, technology is unveiled, and the power of science through commercialization comes to life.

Interphex delivers relevant solutions to the pharmaceutical supply chain through curated education sessions, and networking with over 500 global suppliers to source quality products and services covering the entire development cycle from development to distribution.

Interphex supports certification courses through the Center for Professional Development and Education as well as PDA mini-workshops.

Medical Design & Manufacturing (MD&M)

MD&M hosts trade shows and conferences for medical device, packaging, and automation manufacturers. Conference and technical sessions cover regulatory topics, 3D printing, additive manufacturing, new product development, CAD/CAM software for testing and measurement equipment, med tech, automation, design and manufacturing, and plastics.

BIOMEDevice Boston

BIOMEDevice Boston offers an expo and educational opportunities in the Master Class Conference by MassMEDIC and MEDIcept for biomedical design and product development in Massachusetts.

PITTCON

PITTCON conference and exposition focuses on laboratory sciences and instrumentation innovation. It is the venue for presenting the latest advances in analytical research and scientific instrumentation from thousands of participating exhibitors, researchers and subject matter experts during technical programs.

American Association of Tissue Banks (AATB)

AATB hosts educational courses based on existing standards and regulations as well as guidance documents issued by the AATB.

Animal Research Facilities Conference

The Animal Research Facilities Conference details new planning, design, construction, and operational strategies for high-capacity, highly efficient, flexible, and less labor-intensive animal research space.

Conference topics can include strategies to reduce labor requirements, new space utilization and allocation metrics with benchmarks, work environments for staff health, engagement and collaboration, next-level housing and infrastructure plans for animal model translation, welfare and efficiency, upgrades to mechanical systems, and more.

American Association for Laboratory Animal Science (AALAS)          

AALAS is a laboratory animal science professional association dedicated to the humane care and treatment of laboratory animals used in research and biomedical science. The annual meeting hosts seminars, platform sessions, workshops, panel discussions, poster sessions, and technical trade presentations.

The latest research topics focusing on animal biology, technology, facilities operations, management, and compliance are published in the Journal of the American Association for Laboratory Animal Science, Comparative Medicine, and Laboratory Animal Science Professionals.