| 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. |
| 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. |
| 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)
- Download Brochures of Seminars and Forms
- International and North American Chapters
- Newsletter - monthly
- Career opportunities*
- Post resumes/Job openings
- Links
|
| 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.
|