Glossary
Edit on GitHubPositional
- Superior (cranial): toward the head
- Inferior (caudal): toward the bottom (tail)
- Anterior (ventral): toward the front
- Posterior (dorsal): toward the back
- Medial: Toward the midline of the body
- Lateral: Toward the side of the body
- Internal (deep): Away from the surface of the body
- External (superficial): toward the surface of the body
- Proximal: Toward the main mass of the body
- Distal: Away from the main mass of the body
- Visceral: related to internal organs
- Parietal: related to the body wall
- Midsagittal plane divides the body into left and right halves,
- Coronal plane divides the body between front and back portion,
- Transverse (or horizontal or cross-sectional) plane divides the body into superior and inferior halves
Regulatory Terminologies
- 21 CFR Part 11 / Annex 11: US FDA and EU regulation on electronic records, digital signatures, and document control.
- 21 CFR Part 111: FDA issued guidance on dietary supplements as part of current Good Manufacturing Practice (cGMP), the guidance requires dietary supplement manufactures to have proper control in place for manufacturing, testing, quality control, quarantine, packaging, labeling, and distribution.
- 21 CFR Part 1270-1271: current Good Tissue Practices (GTPs) for companies and laboratories using blood, human cells, tissues, biologics, and other tissue-based products.
- 21 CFR Part 210-211: current Good Manufacturing Practice (cGMP) for all drugs manufactures.
- 21 CFR Part 606: current Good Manufacturing Practice (cGMP) for blood banks, diagnostic labs, and other blood-related companies.
- 21 CFR 820: current Good Manufacturing Practice (cGMP) which defines the Quality System Regulation (QSR) required for medical device manufacturers. The regulations define the requirement for control of design, manufacturing, packaging, labeling, storage, installation, and servicing for medical device companies.
- 510(K): regulatory pathway for medical device that is substantially equivalent to existing products.
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