Ampoule or Ampule – A small glass vial sealed after filling and one of the earliest devices developed for safe storage of sterile injectable unit.
ANDA – Abbreviated New Drug Application (USA).
API – Active Pharmaceutical Ingredient (sometimes also Active Pharmaceutical Intermediaries)– formerly “Raw Material” – Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body. (ICH Q7)
Batch Number – A unique combination of numbers and/or letters which specifically identify a batch or lot and from which the production and distribution history can be determined. Sometimes referred to as a “Lot Number”
Biologic – A therapeutic agent derived from living things.
Biologics – “Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product… applicable to the prevention, treatment, or cure of diseases or injuries of man…”
Biopharmaceuticals – Ethical pharmaceutical drugs derived through bioprocessing.
Biotechnology – A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody), hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical, medical diagnostic device, food, animal and plant industries.
B.P. (British Pharmacopeia) – A compendium of testing and purity criteria for pharmaceuticals, ancillaries, and raw materials.
Calibration – A comparison of a measurement standard or instrument of unknown accuracy to detect, correlate, report, or eliminate by adjustment of any variation in the accuracy of the unknown standard or instrument.
Carcinogen – A substance that causes the development of cancerous growths in living tissue. A chemical is considered to be a carcinogen if it has been evaluated by the International Agency for Cancer Research (IARC) and found to be a carcinogen or potential carcinogen, or if it is listed in the Annual Report on Carcinogens published by the National Toxicology Program
CFR (Code of Federal regulations) Title 21 – The U.S. regulations that directly apply to biopharmaceutical development are contained in Title 21 parts 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General), 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals), and 600 (Biological Products: General). Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New Drugs) apply to critical trials. Part 11 provides criteria which will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures. (also see: cGMPs (current Good Manufacturing Practices))
cGMPs (current Good Manufacturing Practices) – Current accepted standards of design, operation, practice, and sanitization. The FDA is empowered to inspect drug-manufacturing plants in which drugs are processed, manufactured, packaged, and stored for compliance with these standards.
Certificate of Analysis (CoA) – A listing of the results found on analysis of a sample, taken by a defined procedure, of a batch of Active Substance [Active Pharmaceutical Ingredient (API)], Drug Product, or other material. The CoA will also include the tests performed with the associated methods and specifications and the results of those tests.
Change Control – A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated process’s status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.
Clinical Trials – Testing of INDs (Investigational New Drugs) in human subjects to prove safety and efficacy prior to the drug’s approval for marketing. The investigation of a previously untested drug is generally divided into three phases:
1. Phase I: Introducing the product (or drug) into a small number, generally 20 to 80, patients or healthy volunteers to determine the drug’s metabolism, pharmacological actions, and side effects associated with increasing doses.
2. Phase II: introducing the product (or drug) into a small number, generally no more than several hundred, patients with the disease or condition under study to evaluate the effectiveness of the drug, common short-term side effects and risks associated with its use.
3. Phase III: Introducing the product (or drug) into several hundred to several thousand subjects. Studies are expanded controlled and uncontrolled trials performed after preliminary evidence suggesting effectiveness of the drug has been obtained. If the results of the Phase III Clinical Trials are favorable, then the FDA will normally license the drug for manufacture and sale. This phase is usually performed using double blind studies with a placebo and the actual drug.
4. Phase IV: Ongoing testing studies conducted after the drug is approved. This is done to ensure the long-term efficacy of the drug, detect any long-term beneficial and/or detrimental side effects, and to determine additional potential uses for the drug.
Cross-Contamination – Contamination of a material or of a product with another material or product (ICH Q7)
Drug (Medicinal) Product – The dosage form in the final immediate packaging intended for marketing (ICH Q7)
Eutectic Plates – used inside temperature controlled packaging solutions as phase change material
E.P. (European Pharmacopeia) – A compendium of testing and purity criteria for pharmaceuticals, ancillaries, and raw materials.
Excipient – Substances other than API which have been appropriately evaluated for safety and are intentionally included in a drug delivery system.(IPEC)
Expiry date – The date designating the time during which the material is expected to remain within specifications if stored under defined conditions, and after which it should not be used.
FDA – Food and Drug Administration
Final Bulk Product – The final drug product after chemical or biological processing and purification, ready for concentration, drying, and filling into containers prior to dispensing and final filling.
Finished Product – A medicinal product that has undergone all stages of production, including packaging in its final container.
First Expired, First Out principle concept (FEFO) – A distribution procedure that ensures that the stock with the earliest expiry date is distributed and/or used before an identical stock item with a later expiry date is distributed and/or used; earliest expiry/ first out (EEFO) has a similar meaning.
GDP – Good Distribution Practice – set of guidelines published by the MHRA and the EU in relation to the storage and distribution of pharmaceutical and related products.
Generic Drug – A drug produced and marketed under its chemical or “generic” name (e.g. acetaminophen) as opposed to “Tylenol”, a brand name for the former produced by Johnson & Johnson. A generic drug can be sold only after a proprietary drug goes off patent (i.e. when the patent runs out after 17 years). There are numerous generic drug manufacturers. While generic drugs are cheaper for consumers, they still must meet the standards of GMPs as set out by the FDA.
GLP – Good Laboratory Practice
GMP – Good Manufacturing Practice
GTP – Good Transportation Practice – written by Pharmafreight to demonstrate a series of guidelines, based on GDP, on how to handle pharmaceuticals when shipping on an international basis.
GxP – The general description for the family of terms like GMP, GDP etc (i.e. A collective term used to refer to the regulations and guidances governing the research, development, testing, and manufacturing of drugs, medical devices, and biologics.
HS Tariff code – Harmonised System tariff code – a numerical code assigned by customs regimes around the world to identify specific types of product.
Homogeneous material – Material of uniform consistency and composition throughout a batch.
IBC (Intermediate Bulk Container) – A container for storing, transporting, and handling dry materials. Normally bigger than ½ cubic meter but smaller than 3 cubic meters, dust free, able to receive and discharge a variety of materials, and capable of automation.
Intermediate – Partly processed material which must undergo further manufacturing steps before it becomes an excipient or an API.
Labelling – The action involving the selection of the correct label, with the required information, followed by line-clearance and application of the label.
Lot Number – See batch number
Material – A general term used to denote raw materials (starting materials, reagents, process aids, solvents) intermediates, APIs (Active Pharmaceutical Ingredients) and packaging and labelling materials.
Medical Devices – Any health care product that does not achieve its principal intended purposes by chemical action in or on the body or by being metabolized. The term “devices” also includes components, parts, or accessories of medical devices, diagnostic aids such as reagents, antibiotic sensitivity disks, and test kits for in vitro diagnosis of diseases and other conditions.
Medicinal Product – Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances that may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product.
Micronising/Micronizing – The reduction of the particle size of a powder to a unit of equal to one millionth of a meter (µm) or thousandth of a millimeter (25µm are approximately 0.001 inch.)
MSDS (Material Safety Data Sheet) – Document describing the chemical and physical properties of a substance as related to its safe handling and storage. The substance manufacturer originates it.
New Drug Application (NDA) – The New Drug Application contains most of the information included in the IND. Only after FDA approval of the NDA, can distribution and marketing of a new drug begin.
NDC – National Drug Code, required for imports to the USA of most pharmaceutical products.
Original manufacturer – Person or company manufacturing a material to the stage at which it is designated as a pharmaceutical starting material (API or Excipient).
PFI – Pharmaceutical Formulation Intermediaries
Pharmaceutical – A medicinal drug, or relating to or engaged in pharmacy or the manufacture and sale of pharmaceuticals. A pharmaceutical product is generally one that is made up using available chemical compounds.
Procedure – Written, authorized instruction for performing specified operations.
QC (Quality Control) – Checking or testing, that specifications are met, or the regulatory process through which the industry measures actual quality performance, compares it with standards, and acts on the difference.
Quarantine – The status of materials isolated physically or by other effective means pending a decision on their subsequent approval or rejection.
Raw Material – see API
Regulatory Affairs – Drug companies must show that their products consistently meet standards set by government agencies. Regulatory affairs departments document those activities, submit proposals, and follow those proposals through completion or approval.
Record – Documents stating results achieved and/or providing evidence of activities performed. The medium may be paper, magnetic, electronic or optical, photography etc. or combination thereof.
Retained sample – Representative sample of a batch/delivery that is of sufficient quantity to perform at least two full quality control analyses and will be kept for a defined period of time.
Retest Date – The date when the material should be re-examined to ensure that it is still suitable for use. (ICH Q7)
Sampling – Operations designed to obtain a representative portion of a material based on an appropriate statistical procedure, for a defined purpose, e.g. acceptance of consignments, batch release, etc.
Solvent – An inorganic or organic liquid used as a vehicle for the preparation of solutions or suspensions in the manufacture of an intermediate or API (Active Pharmaceutical Ingredient).
SOP (Standard Operating Procedures) – The description of necessary activities to respond to normal and abnormal situations in an operating system. The SOP may include a troubleshooting checklist, list of personnel to contact, etc. SOPs should also describe normal operation, maintenance, and cleaning of the system, and normal operating parameters. An SOP may be created for any system but an SOP must be created for each system requiring qualification.
Specification – A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described for a material.
Traceability – Ability to determine the history, application or location that is under consideration, for example, origin of materials and parts, possession history or distribution of the product after delivery.
USDA – USA Department of Agriculture
U.S.P. (United States Pharmacopeia) – A compendium of testing and purity criteria for pharmaceuticals, ancillaries, and raw materials.
WHO – World Health Organisation