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GlossaryG - I

G
GALP Good Automated Laboratory Practice.
GAMP The GAMP Forum exists to promote the understanding of the regulation and use of computer and control systems within the pharmaceutical manufacturing industry. Whenever possible, GAMP will form relationships with like minded industry associations to create globally harmonized quality standards and will partner with suppliers to identify and share best practices in order to have a positive influence on the quality of computer products used in pharmaceutical operations. ISPE and the GAMP Forum produce: Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture
GAO 1) General Accounting Office (US Government)
2) General Administration Office
GAP Good Analytical Practice.
Gateway A shared connection between a LAN and a larger system, such as a mainframe computer or a large packet-switching network, whose communications protocols are different. Usually slower than a bridge or router, a gateway is a combination of hardware and software with its own processor and memory used to perform protocol conversions. (Ref: Dyson, Dictionary of Networking). It is similar in concept to a translator who hears one side of the communication and translates into an other language. Gateways can provide some security functions, such as acting as routers and firewalls.
GCP Good Clinical Practice.
GDP Good Distribution Practice
GERA Global Electronic Records Association
GIP Good Inspection Practice
GITP Good Information Technology Practice
GGP Good Guidance Practices
Global network An international network that spans all departments, offices, and subsidiaries of the corporation.

Global networks bring their own set of problems, including those of different time zones, languages, established standards, and PTT (Postal Telephone and Telegraph) companies.
(Ref: Dyson, Dictionary of Networking)
GMP Good Manufacturing Practice.
Good clinical practices (GCPs) Term used to describe a collection of loosely-related regulations that define the responsibilities of those involved in a clinical trial. The regulations include those that govern institutional review boards, informed consent, and sponsors and monitors. Refer to 21 Code of Federal Regulations Parts 50 and 56.
Good laboratory practices (GLPs) Regulations of the U.S. Food and Drug Administration and other countries that spell out the requirements for non clinical (animal or laboratory) studies that will be submitted to the regulatory agency to support a marketing application. U.S. GLPs are found in 21 CFR Part 58.
Good manufacturing practices (GMPs) 1. Also known as current good manufacturing practices, CGMPs and GMPS. U.S. regulations in 21 CFR Part 211 contain the minimum current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the Federal Food, Drug, and Cosmetic Act for safely and has the identity and strength and meets the quality and purity characteristics that it claims. There are good manufacturing practices for medical devices found in 21 CFR Part 820 and for blood and blood products found in 21 CFR 606.

2. European Community Guide to Good Manufacturing Practice for Medicinal Products is the fourth volume of the Rules Governing Medicinal Products in the European Community. It is an EC Guide approved by representatives of the pharmaceutical inspection services of the member states of the EC and is effective from the 1st day of January, 1992.

3. The phrase is used generally for rules, regulations or guidelines on the subject issued by any government.
GPEA Government Paper Elimination Act
GPhA Generic Pharmaceutical Association
GPhA represents the manufacturers and distributors of finished generic pharmaceutical products, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic pharmaceutical industry.

GPhA members manufacturer more than 90% of all affordable pharmaceuticals dispensed in the United States. Our products are used in more than one billion prescriptions every year.

The Association maintains its headquarters in Arlington, VA from which its day-to-day business is conducted. The GPhA represents the industry and its member companies through the participation in regulatory, scientific and legislative forums on matters that are of mutual interest and concern to its members.
GRASP Global Regulatory Affairs Submission Projects
(US FDA) Guidance Documents Guidance documents represent the agency’s current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach can be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
H
HACCP Hazard Analysis Critical Control Point (a method commonly used in food)
HAZOP Hazardous and Operability Analysis
Handwritten signature Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
Hash function A function that maps a data item to a numeric value by use of a transformation. A hash function can convert a number that has meaning to a user, such as a key or other identifier, into a value for the location of that data in a structure such as a table.
(Ref: Dyson, Dictionary of Networking)
Hash Value Used as a "fingerprint" for a file, which can be used to detect changes in the file. With a good hash function, a change of a single bit in the file will cause the hash value to be very different. Typically a hash value is computed on the original file (or more generally, on any electronic record), and later the hash value is computed again. If the hash values agree, the file is guaranteed, to a very, very high degree of certainty, to have not changed.

Labcompliance has a program for download in the users club. It is straightforward and easy to use. It shows the concept and is recommended to get experience and for manual operation. Correct functioning of such software should be validated. Therefore Labcompliance also has complete validation documents available for download, e.g., specifications, initial and ongoing testing. To preview and registration for the users club, click here.
Health Industry Manufacturers Association
  • Site offers member companies the latest information on key programs and industry events.
  • Current topics from the HWA newsletter, HIMA news releases.
  • HIMA publications for sale.
  • FDA Today - Key inspection documents
  • Year 2000
  • Links to other sites
  • Employment
Herbal Medicinal Product 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; EU Directive 2004/24/EC, Article 1

A term generally applicable to the finished product and pertains to a medicinal product containing plant materials and/or plant preparations as its active ingredients.

Important: If any other material is added (e.g. a mineral supplement), the product is no longer a hmp by definition and thus not eligible for any of the exemptions allowed to hmp's.
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); EU Directive 2004/24/EC, Article 1
Heterogeneous network A network that consists of workstations, servers, network interface cards, operating systems, and applications from many vendors, all working together as a single unit. The network may also use different media and different protocols over different network links.
(Ref: Dyson, Dictionary of Networking)
HIMA see Health Industry Manufacturers Association
HOKLAS Hong Kong Laboratory Accreditation Scheme (HOKLAS)
Host name The name given to a device connected to the network. The name is limited to 15 characters.
Hotfix Microsoft’s term for a bug fix, which is accomplished by replacing one or more existing files in the operating system or application with revised versions.
HTML Hyper Text Markup Language
HTTP Hyper Text Transport Protocol
Hub

A device used to extend a network so that additional workstations can be attached. There are two main types of hubs:

  • Active hubs amplify transmission signals to extend cable length and ports.
  • Passive hubs split the transmission signal, allowing additional workstations to be added, usually at a loss of distance.

In some star networks, a hub is the central controlling device.
(Ref: Dyson, Dictionary of Networking)

Hub cascade port A port available on many hubs that allows the user to connect or cascadeto another hub.
HVAC Heating ventilation and air conditioning, term used for this critical utilitiy
Hybrid systems are a combination of electronic records and paper records. Today they are most frequently used in analytical laboratories. Raw data are recorded electronically to reconstruct the analysis but the final results are printed and signed on paper. The FDA does not prohibit hybrid systems but has expressed some concerns about their acceptability.
I
IAF International Accreditation Forum

The International Accreditation Forum, Inc. (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment. Its primary function is to develop a world wide program of conformity assessment which will promote the elimination of non tariff barriers to trade.

IAF membership includes accreditation bodies from nations in all parts of the world, industry representatives and accredited certification/registration bodies, in an international organisation which seeks to encourage development of a single world-wide system of mutual recognition of conformity assessment certificates.
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Members are from industry and regulatory agencies.

1. Provides a forum for a constructive dialog between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan.

2.Identifies areas where modifications in technical requirements or greater mutual acceptance of research and development procedures could lead to a more economical use of human, animal and material resources, without compromising safety

3.Makes recommendations on practical ways to achieve greater harmonization in the interpretation and applications of technical and requirements for registration.
ICMS Instrument Calibration and Maintenance Scheduling
ICP 1) In process control
2) The International Pharmaceutical Excipients Council
Was formed in 1991 in order to develop harmonized pharmacopeia excipient standards, harmonized GMP guidelines, and harmonized new excipient safety evaluation guidelines
IDMA Indian Drug Manufacturing Association
IEC International Electro technical Commission
IEEE Institute of Electrical and Electronics Engineers Standards
IEST Institute of environmental sciences and technology, they made the famous fed st 209 and now they are publishing the ISO standards for clean rooms
IFPMA International Federation of Pharmaceutical Manufacturers Associations
IGPA International Generic Pharmaceutical Alliance
ILAC International Laboratory Accreditation Cooperation. Working for international acceptance of data generated by accredited organizations. Developed the ISO Guide 25.
Inspection Structured peer reviews of user requirement specifications, design specifications and documentation.
IND Investigational New Drug
Input Device Equipment that translates external information into electrical pulses that the computer can understand. Examples are thermocouples, RTDs (Resistance Temperature Devices) flow meters, load cells, Ph meters, pressure gauges, control panels, modems, cathode ray tubes (CRT), data entry touch screens and operator keyboards.

Examples of functions are:

a.Thermocouple/RTD provides temperature input for operation of a retort.

b. Flow meter provides volume of liquid component going into a mixing tank.

b.Operator keyboard used to enter weights, batch, menu number and other processing information.
(US FDA)
Inspection Guides
Inspection guides are used by field investigators to assist them in performing inspections of specific products or processes. Inspection guides were previously called Inspectors Technical Guides (ITGs). Both are meant to provide investigators with additional technical information when they encounter highly technical issues during inspections. The Office of Regulatory Affairs (ORA) issues the inspection guides.
(US FDA) Inspector’s Technical Guide ITGs are similar to the inspection guides but are more limited in scope.
Installation Qualification (IQ) Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.
Institute of Validation Technology
(IVT)
  • Publisher of the Journal of Validation Technology and the Journal of cGMP Compliance
  • Protocol templates, back issues, special editions, newsletter, conferences and full video library
  • Extensive documentation archive
  • Membership to the Institute of Validation Technology

IVT's mission is to expand the global knowledge base for validation and compliance professionals in FDA-regulated industries through the development of academic journals, timely educational conferences and exhaustive documentation By creating a cooperative forum between industry experts and FDA personnel, IVT is the only professional society exclusively dedicated to advancing validation technology practices and assuring compliance with FDA regulations.

Interlaboratory test comparisons Organization, performance and evaluation of tests on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions. [92]
Internal audit A periodic process, carried out by laboratory staff, to check that the laboratory’s quality assurance system is effective, documented and adhered to by all staff.
International standard Standard that is adopted by an international standardizing/standards organization and made available to the public. [92]
Interpharma Swiss Pharmaceutical Research Companies
IND Investigational new drug application
An application which a drug sponsor must submit to FDA before beginning tests of a new drug on humans. The IND contains the plan for the study and is supposed to give a complete picture of the drug, including its structural formula, animal test results, and manufacturing information. Detailed instructions for the submission of IND's can be found in 21 CFR 312.
IOM FDA Investigations Operations Manual
IP address The unique 32-bit number that identifies a computer on the Internet or some other Internet Protocol network.

An IP address is usually written (in decimal) as four numbers separated by dots or periods and can be divided into two parts. The network address is made up from the high-order bits in the address, and the host address comprises the rest. In addition, the host part of the address can be further subdivided to allow for a subnet address.

These numbers are very difficult for most people to remember, so humans tend to refer to computers by their domain names instead.
(Ref: Dyson, Dictionary of Networking)
IPEC International Pharmaceutical Excipients Council (of the Americas)
IRB Institutional Review Board (frequently mentioned in US FDA warning letters) US FDA regulation
ISA In connection with engineering drawings
Instrument Society of America. ISA has standardized symbols for equipment and instrumentation (e.g. pumps, valves, motors, etc.) typically used on engineering drawings.
ISDN
Integrated Services Digital Network - A standard for a worldwide digital communications network originally designed to replace all current systems with a completely digital, synchronous, full-duplex transmission system.

Computers and other devices connect to ISDN via simple, standardized interfaces. They can transmit voice, video, and data, all on the same line.
(Ref: Dyson, Dictionary of Networking)
ISO International Organization for Standardization. Agency responsible for developing international standards; over 160 technical committees, 650 sub-committees and 1500 working groups; more than 6000 ISO standards published; represents more than 90 countries. Founded in 1947.
ISO/IEC 17025 ISO Standard "General Requirements for the Competence of Calibration and Testing Laboratories." Like the ISO 9000 series standards, compliance with ISO/IEC Standard 17025 voluntary. Is specifically intended only for calibration and testing laboratories. ISO/IEC Standard 17025 is typically used as a guide against which a laboratory’s quality system can be evaluated.
ISO 9000 series standards The ISO 9000 series standards (9001, 9002, 9003) apply internationally. They are relevant, not just for laboratories, but for all types of manufacturing and service organizations. At this time, the ISO 9000 standards are primarily voluntary. However, many companies are finding that their customers are demanding ISO 9000 series compliance or registration as a condition for doing business.
ISO/IEC Guide 25
Obsolete
Replaced by ISO17025
"General Requirements for the Competence of Calibration and Testing Laboratories." Like the ISO 9000 series standards, compliance with ISO/IEC Guide 25 is voluntary. Is specifically intended only for calibration and testing laboratories. ISO/IEC Guide 25 is typically used as a guide against which a laboratory’s quality system can be evaluated. Unlike the ISO 9000 series standards, it is not possible to apply for an ISO/IEC Guide 25 registration. Content of ISO/IEC Guide 25 is similar to EN 45001.
ISP Internet Service Provider - A company that provides commercial or residential customers access to the Internet via dedicated or dial-up connections. An ISP will normally have several servers and a high-speed connection to an Internet backbone. Some ISPs also offer Web site hosting services and free e-mail to their subscribers.
(Ref: Dyson, Dictionary of Networking)
ISPE
  • International Society for Pharmaceutical Engineering
  • Pharm Engineering - Official Journal of ISPE – monthly
  • On-line Article Index - by topic, author, text, search
  • Baseline engineering guides publishing these with FDA
  • Bulk Pharmaceutical Chemicals
  • Oral Solid Dosage
  • Sterile Manufacturing Facilities
  • Under development-biotechnology
  • GAMP Guide (bound and electronic version)
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  • International and North American Chapters
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IT International Technology
IVD In Vitro Diagnoistic Device
The FDA regulates in vitro diagnostic products (IVDs) as devices. IVDs are "reagents, instruments & systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease." IVDs are most commonly used in clinical labs but may also be used in other settings to collect, prepare and examine specimens taken from the human body.