21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American; hence, the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts G & H: Packaging, Labeling and Distribution
Read More21 CFR 211 Subparts I: Laboratory Controls
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts I: Laboratory Controls
Read More21 CFR 211 Subparts J & K: Records and Salvaged Drug Product
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts J & K: Records and Salvaged Drug Product
Read MoreFDA Quality Systems Guideline
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading FDA Quality Systems Guideline
Read MorecGMP Compliance and Non-Compliance
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American; hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading cGMP Compliance and Non-Compliance
Read MorecGMP Compliance: Process Validation
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading cGMP Compliance: Process Validation
Read MoreManagement of Pharmaceutical Water in a GMP Environment
Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility… Continue reading Management of Pharmaceutical Water in a GMP Environment
Read MoreAntiperspirant and Deodorant: Green Technology for Wetness and Odor Control
Underarm actives for wetness (antiperspirants) and odor control (Deodorants and Deo-Cologne’s) continue to evolve as consumer grooming habits change, global regulations impact what can be sold to consumers, and changing emotive perceptions of safety and acceptable actives tie in with new scientific information about safety. This was demonstrated in the 1970’s with the banning of… Continue reading Antiperspirant and Deodorant: Green Technology for Wetness and Odor Control
Read MoreINCI: International Nomenclature of Cosmetic Ingredients
In 1973 The Cosmetic, Toiletry, Fragrance Association (CTFA) developed an industry voluntary process for assigning ingredient names that provides the consumer and medical field a common approach to understanding what is formulated in a personal care product. This process was accepted by the United States Food & Drug Administration (FDA) and the global regulatory community,… Continue reading INCI: International Nomenclature of Cosmetic Ingredients
Read MoreScope of the FDA: History and FDA Regulations
Most industries in the US are regulated by local, state, and federal regulators and pharmaceutical manufacturing companies are some of the most highly regulated, particularly at the federal level. Pharmaceutical Quality affects every American hence the FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality are the Current… Continue reading Scope of the FDA: History and FDA Regulations
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