Full Circle Consulting
EMMA International can be there every step of the way for your product! From product development to helping with QMS upkeep and post-market monitoring, EMMA is here to bring your product full-circle. The expertise of the EMMA team can help you get through the biggest quality and regulatory hurdles in the life science industry with ease.
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The American Society for Testing and Materials (ASTM) is an organization that publishes production and testing standards for a variety of differing industries. Many of the Food and Drug Administration (FDA) requirements for bringing a medical device to market rely on these standards for testing and evaluation, referred to as recognized consensus standards. ASTM F2100, which was most recently revised in 2023, contains performance standards for the materials used in medical face masks [1]. These types of standards documents contain information for a variety of styles/types of face masks and the testing requirements to meet higher classification standards (Level 1 barrier, Level 2 barrier, or Level 3 barrier).
The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations as regulatory criteria for medical devices, these are referred to as recognized consensus standards [1]. Examples of some of the organizations that develop these standards are: International Organization for Standardization (ISO) standards, American Society for Testing and Materials (ASTM) standards, American National Standards Institute (ANSI) standards, International Electrotechnical Commission (IEC) standards, etc. The IEC is an organization that develops standards to standardize the electrical and electronic fields [2].
Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures manufacturing products are consistently produced and controlled according to set quality standards. For pharmaceutical production this is especially important as the drugs manufactured are injected directly into patients. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 2 of a 2-part series and discusses the first 5 rules and why they are important.
Good Manufacturing Practices (GMP) is a system that consists of processes, procedures and documentation that ensures products are consistently produced and controlled according to set quality standards; for pharmaceutical production this is especially important. In general, there are 10 golden rules that apply in order to fulfill the GMP requirements. This article is part 1 of a 2-part series that discusses the first 5 rules and why they are important.
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