Intermediate

Developing and Optimizing of Roll Compacted Granulations for Tablets

Granulating is the most popular way to prepare materials for tableting. Many excipients and actives used in modern direct compression processes are granulated. The granulation process, using only pressure for particle size enlargement, is dry granulation (Roll compaction (RC)). The RC process, even though simple in principle, can be quite complex. Besides proper machine setup,… Continue reading Developing and Optimizing of Roll Compacted Granulations for Tablets

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

21 CFR 211 Subparts E & F: Control of Components and Production/Process Control

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 E & F: Control of Components and Production/Process Control

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

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