Rx | | Abbreviation for a prespription and in some contexts also for prescrition drugs |
| generic | A generic drug or "Generic" is a pharmaceutical product that is not protected by a patent anymore. Those products are typically sold via the name of the active ingredient (e.g. Acetylsalicylic Acid = A.S.S. rather than Aspirin) or generic name, thus the name. |
OTC | Over-the-Counter | A drug that doesn't require a prespription but is sold over the counter, so basically non-Rx. Be careful not to confuse this with Order-to-Cash, abbreviated OTC as well or O2C. People might use the same abbreviation for both terms. |
| API | Active Pharmaceutical Ingredient | |
| UDI | Unique Device Identifyer | used for medical devices |
| GMP | Good Manufacturing Practice | |
| GLP | Good Laboratory Practice | |
| GDP | Good Distribution Practice | |
| GxP | | summarizing GMP and GLP and all the other flavors |
| GAMP | Good Automated Manufacturing Practice | GAMP is a guide for the validation of automated systems in pharmaceutical Manufacturing and was issued by the UK Pharmaceutical Industry Computer Validation Forum. It is often used by companies to guide them through a validation project. see: www.ISPE.org |
| CFR | Code of Federal Regulation | US laws, covers for example GMP guidelines, e.g. the rule for electrionic records and signatures can be found in 21 CFR Part 11. |
| Part11 | | Part of the CFR covering digital and electronic signatures |
| NDC | National Drug Code | used for any national code used to identify pharmaceutical products, often used for the US NDC specifically |
| FDA | Food and Drug Administration | even though other countries also run an FDA, this typically relates to the US FDA |
| MoH | Ministry of Health | |
| NDA | New Drug Application | the application you have to submit to register a new drug. Careful not to mix this up with a Non-Disclosure Agreement. |
| CANDA | Comuter Aided (or assisted) NDA | |
| ANDA | abbreviated NDA | |
| PDMA | Prescription Drug Marketing Act | |
| CMO | Contract Manufacturing Organization | Company that manufactures a certain product on behalf of another company |
| MES | Manufacturing Execution System | A computer system used to manage the productio activitities (both manual and automated) on the plant floor |
| LIMS | Laboratory Information Management System | A computer system used to manage laboratory tasks (like chemical analysis for quality control), manages the resulting data and ultimately the batch characteristics. |
| CPV | Continued Process Verification | |
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