GMP Glossary & Definitions
Decontamination:
Under decontamination the action of separating and eliminating contamination is defined. The contaminants might be of chemical and/or microbiological nature.
Dedicated Rooms or Facility:
Under dedicated rooms or facility a room or suite of rooms or facility are defined with equipment and services used only for the manufacture of one product, or a closely related group of products.
Defect Category Critical:
Examples for a critical defect are problems in plant, systems or materials which affect the Quality, safety, purity or efficacy of products and/or can lead to health threatening conditions in finished pharmaceutical products or materials.
Defect Category Major:
Examples for a major defect are problems in plant, systems or materials which can affect the Quality, safety, purity or efficacy of Products or which lead to non-health threatening conditions in finished Pharmaceutical Products.
Defect Category Minor:
Examples for a minor defect are problems that if they are not corrected, would not cause harm to the Product or patient, but indicate minor breaches to GMP rules.
Degradation Product:
A degradation product is defined as a molecule resulting from a chemical change in the Drug Substance / Active Pharmaceutical Ingredient (API). This might result by the action of e.g. pH, light, temperature or water or by reaction with an Excipient and/or the immediate Container/closure system or if the Drug Substance brought about over time.
Design history file (DHF):
Compilation of records which describes the design history of a finished device.
or
Design history file (DHF) means a compilation of records which describes the design history of a finished device.
Design input:
Physical and performance requirements of a device that are used as a basis for device design.
Design output:
Results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, ist packaging and labeling, and the device master record.
Design review:
Documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
Development report:
A report that summarizes the major stages of API development from early stages through large-scale manufacturing.
Device history record (DHR):
Compilation of records containing the production history of a finished device. Device master record (DMS) means a compilation of records containing the procedures and specifications for a finished device.
Device master record (DMS):
Means a compilation of records containing the procedures and specifications for a finished device.
Design Qualification:
The design qualification should provide documented evidence that the design of e.g. a facility, equipment, services or operation is suitable for the intended purpose. This includes also meeting the Quality and GMP requirements.
Development Report:
The Development Report is defined as a compilation of all documents as well as the supporting documentation for the development of a product from conception to market.
Deviations / Non-conformance:
A Deviation/ Non-conformance is any unplanned event or failure to meet SOPs and/or failure to meet specified limits, which may potentially affect the safety, identity, efficacy, quality, or purity of products or a violation of the cGMP regulations or internal processes and procedures.
Deviation Trending:
Deviations must be trended to detect/predict reoccurrence problems and to monitor the effectiveness of the implementation of the corrective actions. The frequency of the trend analysis and reporting must be at least monthly.
Distribution:
The Distribution is defined as the delivery of an approved finished drug product to authorized sites, wholesalers, distributors or persons which are authorized to deliver drug products to the public.
Documentation:
Documentation is defined as any procedures, instructions, logbooks, records, raw data, manuals, and policies associated with the development, manufacture, testing, marketing and distribution of a medicinal product or devices required demonstrating compliance with GMP standards and any other applicable worldwide regulatory requirements.
Dosage Form:
The dosage form is defined as the product form of the finished product e.g. tablet, capsule, aerosol, pre-filled syringe, elixir and suppository.
Dosage Formulation:
The form in which a drug is produced. Pharmaceutical companies use many methods of drug delivery, including oils, gels, creams and sprays; capsules and tablets; injects; implants; suppositories; and liquids and syrups.
Dosage strength:
Amount of active drug contained in a particular formulation; for example 50, 100, or 500 milligrams.
Double-blind study:
A scientific study in which neither the subject (patients) nor the investigators (treating physicians) know who is receiving the experimental treatment and who is receiving a placebo (a control or "sugar pill").
Drug:
As defined in US CFR Section 201(g)(1) of the Act means (a) articles that are recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and articles (other than food) intended to affect the structure or any function of the body of humans or other animals.
Drug delivery:
The process by which a formulated drug is administered to the patient. Traditional methods have been orally or by injection. Newer methods include through the skin by application of a transdermial patch, or across the nasal membrane by administration of a specially formulated nasal spray.
Drug interaction:
Modification of the effect of one drug by another in a way that diminishes, negates or enhances the effectiveness or safety of one or both drugs.
Drug Product:
A Drug Product is defined as any product that is offered for sale or distribution and administration to human beings or animals for treatment. Examples for treatment might be but is not limited to preventing and diagnosing disease, for anesthesia, for contraception, and for otherwise altering normal physiological functions.
or
A finished dosage form, for example, a tablet, capsule or solution, that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an API but is intended to be used as a placebo.
Drug Regulatory Affairs (DRA):
The Drug Regulatory Affairs department is the group being responsible for interaction with the regulatory authorities in the registration of Drug Substance / Active Pharmaceutical Ingredient (APIs) and Drug Products.
