H
HACCP Plan
A document prepared in accordance with the principles of HACCP to ensure the control of hazards which are significant for pharmaceutical quality in the production and supply chain. [Hazard and Risk Analysis, WHO]
Hapten
A low molecular weight molecule that is not in itself antigenic unless conjugated to a 'carrier' molecule. [EU GMP Guide, Annex 2]
Hardware Acceptance Test Specification
Statements for the testing of all key aspects of hardware installation to assure adherence to appropriate codes and approved design intentions and that the recommendations of the regulated user have been suitably considered. [PIC/S PI 011-3]
Hardware Design Specification
Description of the hardware on which the software resides and how it is to be connected to any system or equipment. [PIC/S PI 011-3]
Harm
Damage to health, including the damage that can occur from loss of product quality or availability. [ICH Q9, Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Harvesting
Procedure by which the cells, inclusion bodies or crude supernatants containing the unpurified active ingredient are recovered. [Canadian GMP Guidelines, Annex 2]
Hazard
The potential source of harm (ISO/IEC Guide 51). [ICH Q9]
Any circumstance in the production, control and distribution of a pharmaceutical which can cause an adverse health effect. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Hazard Analysis
The process of collecting and evaluating information on hazards which should be addressed in the HACCP plan. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Healthcare Establishment
Establishments supplying medicinal products to their own patients in line with national legislation. [PIC/S PE 010-4]
HEPA Filter
Retentive matrix designed to remove a defined percentage of particulate matter of a defined size. [PIC/S PI 007-6]
High efficiency particulate air filter with minimum 0.3 µm particle retaining efficiency of 99.97 percent. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Herbal Material
Herbal Materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting or stir-baking with honey, alcoholic beverages or other materials. [Specific Pharmaceutical Products, WHO]
Herbal Medicinal Product
Medicinal product containing, as active ingredients, exclusively plant material and/or vegetable drug preparations. [EU GMP Guide, Glossary]
Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. [Directive 2001/83/EC]
Herbal Medicine
Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products. [Specific Pharmaceutical Products, WHO]
Herbal Preparation
Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates. [Directive 2001/83/EC]
Herbal Product
Medicinal products containing, exclusively, plant material and/or vegetable drug preparations as active ingredients. In some traditions, materials of inorganic or animal origin can also be present. [ICH Q3A]
Herbal Substance
All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author). [Directive 2001/83/EC]
Highly Purified Water
Low endotoxin water, reverse osmosis water. [Pharmacopoea Europaea]
Highly Water Soluble Drug
Drugs with a dose/solubility volume of less than or equal to 250 ml over a pH range of 1.2 to 6.8. (Example: Compound A has as its lowest solubility at 37 +/–0.5 °C, 1.0 mg/ml at pH 6.8, and is available in 100 mg, 200 mg, and 400 mg strengths. This drug would be considered a low solubility drug as its dose/solubility volume is greater than 250 ml (400 mg/1.0 mg/ml = 400 ml). [ICH Q6A]
Holding
Storing medicinal products. [EU GDP Guidelines]
Home Cryogenic Vessel
Mobile cryogenic vessel designed to hold liquid oxygen and dispense gaseous oxygen at patients' home. [EU GMP Guide, Annex 6]
Homeopathic Medicinal Product
Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles. [Directive 2001/83/EC]
Homogeneity
A material is regarded as homogeneous when it is all of the same origin (e.g. from the same batch) and as non-homogeneous when it is of differing origins. [Sampling Operations, WHO]
Hot-Cell
Shielded workstation for manufacture and handling of radioactive materials. Hot-cells are not necessarily designed as an isolator. [EU GMP Guide, Annex 3]
A total containment cabinet shielded with lead. [Canadian GMP Guidelines 2009, Annex 3]
An aseptic total containment cabinet providing a Class A (with Laminar flow), or Class B (with Turbulent flow) environment, and is shielded with lead of various thickness. [Canada GMP Guidelines 2009, Annex 5]
Hybridoma
An immortalised cell line that secrete desired (monoclonal) antibodies and are typically derived by fusing B-lymphocytes with tumour cells. [EU GMP Guide, Annex 2]
Hydrostatic Pressure Test
Test performed as required by national or international regulations, in order to ensure that pressure containers are able to withstand pressures up to the container's design pressure. [EU GMP Guide, Annex 6]
A document prepared in accordance with the principles of HACCP to ensure the control of hazards which are significant for pharmaceutical quality in the production and supply chain. [Hazard and Risk Analysis, WHO]
Hapten
A low molecular weight molecule that is not in itself antigenic unless conjugated to a 'carrier' molecule. [EU GMP Guide, Annex 2]
Hardware Acceptance Test Specification
Statements for the testing of all key aspects of hardware installation to assure adherence to appropriate codes and approved design intentions and that the recommendations of the regulated user have been suitably considered. [PIC/S PI 011-3]
Hardware Design Specification
Description of the hardware on which the software resides and how it is to be connected to any system or equipment. [PIC/S PI 011-3]
Harm
Damage to health, including the damage that can occur from loss of product quality or availability. [ICH Q9, Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Harvesting
Procedure by which the cells, inclusion bodies or crude supernatants containing the unpurified active ingredient are recovered. [Canadian GMP Guidelines, Annex 2]
Hazard
The potential source of harm (ISO/IEC Guide 51). [ICH Q9]
Any circumstance in the production, control and distribution of a pharmaceutical which can cause an adverse health effect. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Hazard Analysis
The process of collecting and evaluating information on hazards which should be addressed in the HACCP plan. [Hazard and Risk Analysis in Pharmaceutical Products, WHO]
Healthcare Establishment
Establishments supplying medicinal products to their own patients in line with national legislation. [PIC/S PE 010-4]
HEPA Filter
Retentive matrix designed to remove a defined percentage of particulate matter of a defined size. [PIC/S PI 007-6]
High efficiency particulate air filter with minimum 0.3 µm particle retaining efficiency of 99.97 percent. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Herbal Material
Herbal Materials include, in addition to herbs, fresh juices, gums, fixed oils, essential oils, resins and dry powders of herbs. In some countries, these materials may be processed by various local procedures, such as steaming, roasting or stir-baking with honey, alcoholic beverages or other materials. [Specific Pharmaceutical Products, WHO]
Herbal Medicinal Product
Medicinal product containing, as active ingredients, exclusively plant material and/or vegetable drug preparations. [EU GMP Guide, Glossary]
Any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. [Directive 2001/83/EC]
Herbal Medicine
Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products. [Specific Pharmaceutical Products, WHO]
Herbal Preparation
Preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates. [Directive 2001/83/EC]
Herbal Product
Medicinal products containing, exclusively, plant material and/or vegetable drug preparations as active ingredients. In some traditions, materials of inorganic or animal origin can also be present. [ICH Q3A]
Herbal Substance
All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author). [Directive 2001/83/EC]
Highly Purified Water
Low endotoxin water, reverse osmosis water. [Pharmacopoea Europaea]
Highly Water Soluble Drug
Drugs with a dose/solubility volume of less than or equal to 250 ml over a pH range of 1.2 to 6.8. (Example: Compound A has as its lowest solubility at 37 +/–0.5 °C, 1.0 mg/ml at pH 6.8, and is available in 100 mg, 200 mg, and 400 mg strengths. This drug would be considered a low solubility drug as its dose/solubility volume is greater than 250 ml (400 mg/1.0 mg/ml = 400 ml). [ICH Q6A]
Holding
Storing medicinal products. [EU GDP Guidelines]
Home Cryogenic Vessel
Mobile cryogenic vessel designed to hold liquid oxygen and dispense gaseous oxygen at patients' home. [EU GMP Guide, Annex 6]
Homeopathic Medicinal Product
Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles. [Directive 2001/83/EC]
Homogeneity
A material is regarded as homogeneous when it is all of the same origin (e.g. from the same batch) and as non-homogeneous when it is of differing origins. [Sampling Operations, WHO]
Hot-Cell
Shielded workstation for manufacture and handling of radioactive materials. Hot-cells are not necessarily designed as an isolator. [EU GMP Guide, Annex 3]
A total containment cabinet shielded with lead. [Canadian GMP Guidelines 2009, Annex 3]
An aseptic total containment cabinet providing a Class A (with Laminar flow), or Class B (with Turbulent flow) environment, and is shielded with lead of various thickness. [Canada GMP Guidelines 2009, Annex 5]
Hybridoma
An immortalised cell line that secrete desired (monoclonal) antibodies and are typically derived by fusing B-lymphocytes with tumour cells. [EU GMP Guide, Annex 2]
Hydrostatic Pressure Test
Test performed as required by national or international regulations, in order to ensure that pressure containers are able to withstand pressures up to the container's design pressure. [EU GMP Guide, Annex 6]