Subject: GMP

21 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

21 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

FDA 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

cGMP 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

cGMP 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

Management 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

Microbiology for the Non-Microbiologist

Appropriate as a GMP Microbiological Refresher With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished products, it has become increasingly important for companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of… Continue reading Microbiology for the Non-Microbiologist

Scope 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

21 CFR 211 Subparts A & B: Quality and Personnel

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 standards for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts A & B: Quality and Personnel

21 CFR 211 Subparts C & D: Facility and Equipment

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 standards for ensuring pharmaceutical quality are the Current… Continue reading 21 CFR 211 Subparts C & D: Facility and Equipment