| OAI |
Official Action Indicated. Observation category
in FDA's establishment inspection reports |
| OASIS |
FDA Operational & Admin. Sys. Import Support
(OASIS)
OASIS is a system used for regulation of imported products. It
operates in conjunction with the US Bureau of Customs and Border
Protection's ACS, which maintains information on imported products
subject to tariffs or other restrictions. |
| Obsolescence |
The final phase in a system's life cycle when
the system is retired from use and taken off the market. At Agilent
technologies, an obsolescence plan documents the support activities
guaranteed for up to 10 years following obsolescence. |
| OECD |
Organization for Economic Cooperation and
Development. |
| OIG |
Office of Inspector General |
| OIML |
International Organization of Legal Metrology |
| OMB |
FDA's Office Management and Budget |
| OOS |
Out of specification situation. Requires
failure investigation and corrective and preventive action plan. |
| OOSRR |
Out-of-Specification Result Report |
| OOT |
Out of trend |
| Open
system |
Open system means an
environment in which system access is not controlled by persons who
are responsible for the content of electronic records that are on
the system. |
| Operational Qualification
(OQ) |
Documented verification that the equipment
related system or subsystem performs as intended throughout
representative or anticipated operating ranges |
| OPI |
Orphan Pharma International |
| ORA |
FDA's Office of Regulatory Affairs |
| Orange Book |
1) A standard from the US Government National
Computer Security Council (an arm of the U.S. National Security
Agency), "Trusted Computer System Evaluation Criteria, DOD standard
5200.28-STD, December 1985" which defines criteria for trusted
computer products. There are four levels, A, B, C, and D. Each level
adds more features and requirements.
2) Electronic: US FDA publication, Approved Drug Products with
Therapeutic Equivalence Evaluations (the List), identifies drug
products approved on the basis of safety and effectiveness by the
Food and Drug Administration (FDA) under the Federal Food, Drug, and
Cosmetic Act (the Act).
3) The Orange Book:Management of Risk - Principles and Concepts |
| Orange Guide |
Orange Guide is the UK's version of the EU GMPs
and includes a number of other documents. It is not available on the
net. Its proper title is 'Rules and Guidance for Pharmaceutical
Manufacturers and Distributors 2002' published in the UK by the TSO
( www.tso.co.uk ). But you don't need it; what it contains is the EU
GMP Directive and guidelines plus UK national legislation and a lot
of other helpful but not legally binding advice for manufacturers
and distributors of medicines. |
| ORO |
FDA's Office of Regional Operations |
| OSHA |
Occupational Safety and Health Administration. |
| OSI |
Open System Interconnection. Networking
framework or implementing communication protocols in 7 layer. Was
widely used and now serves as a teaching model for all other
protocols.
1. Physical 2.Data Link 3. Network 4. Transport 5. Session .
Presentation 7. Application |
| OTC |
Over-The-Counter (medications) |
| Out-of-control |
Reference to a situation in which compliance
with GMPs is not evident. The facility or operation is considered to
be out of control. |
| Output Devices |
Equipment that receives electrical pulses from
the computer and either causes an action to occur, generally in
controlling the manufacturing process functions, or passively
records data. Examples are valves, switches, motors, solenoids,
cathode ray tubes (CRTs), printers, and alarms. Examples of
functions are:
a. Solenoid activates the impeller of a mixer.
b. Valve controls the amount of steam delivered to a thermal
process.
c. Printer records significant events during a sterilization
process.
d. Alarm (buzzer, bell, light, etc.) sounds when temperature in a
holding tank drops below the desired temperature. |
| PAC |
1) Pacific Accreditation Cooperation |
| PAC |
1) Pacific Accreditation Cooperation |
| PACAP |
Post-Approval Change Authorization Procedure |
| PAI |
Pre-Approval Inspection |
| Parenteral Drug
Association (PDA) |
- Develops and publishes technical papers on topics related to
the pharmaceutical industry
- Task forces include 21 CFR Part 11, validation of
computerized data acquisition systems
- Organizes training courses and conferences
- Publishes Journal of Pharmaceutical Science and Technology
- Has worldwide list of contacts
- On-line discussion group Pharmaceutical Sci-Tech
- PDA Letter - showcases PDA events and also FDA Regulatory
and Industry News - Monthly Newsletter
( Members only)
- PDA archive - 50 years of PDA publications
- Consultants and contract manufacturers listings
|
| PASG |
(UK) Pharmaceutical Analysis Science Group |
| Password |
A security method that identifies a specific,
authorized user of a computer system, a network, or a resource by a
unique string of characters.
(Ref: Dyson, Dictionary of Networking) |
| Password encryption |
In certain operating systems, the password you
enter to gain access to the system is not stored as ordinary text,
but is encrypted, and this encrypted form is compared against the
encrypted password stored on the server. If the two match, the logon
continues; if not, the logon attempt is rejected.
(Ref: Dyson, Dictionary of Networking) |
| PAT |
Process Analytical Technology |
| Patch |
A patch (sometimes called
a "fix") is a quick repair job for a piece of programming. A patch
is the immediate solution that is provided to users; it can
sometimes be downloaded from the software maker's website. The patch
is not necessarily the best solution for the problem, and the
product developers often find a better solution to provide when they
package the product for its next release. A patch is usually
developed and distributed as a replacement for or an insertion in
compiled code (that is, in a binary file or object module). In
larger operating systems, a special program is provided to manage
and track the installation of patches |
| PBR |
Production Batch Record |
| PDA |
see Parenteral Drug
Association |
| PDE |
permissible daily exposure |
| PDF |
Portable Document Format -
A file format standard developed by Adobe Systems and others for use
in electronic documents. A file in this format usually has the
filename extension of .PDF.
(Ref: Dyson, Dictionary of Networking) |
| PDMA |
Prescription Drug
Marketing |
| PDUFA |
Prescreption Drug User Fee
Act |
| PECA |
Protocol to the Europe
Agreements on European Conformity |
| PER |
Pharmaceutical Evaluation
Report |
| PER |
Product Evaluation and
Recommendation |
| PERF |
Pan European Regulatory
Forum |
|
Peer-to-peer network |
A LAN in which drives,
files, and printers on each PC can be available to every other PC on
the network, eliminating the need for a dedicated file server. Each
PC can still run local applications. Peer-to-peer networks
decentralize all data access and security control.
Peer-to-peer networks introduce their own system management
problems, including administration and responsibility for system
backup, reliability, and security. Peer-to-peer systems are often
used in relatively small networks, with two to ten users, and can be
based on MS-DOS, Windows, or Unix. Performance is not usually as
good on a peer-to-peer network as under the client/server model,
especially under heavy traffic loads.
(Ref: Dyson, Dictionary of Networking) |
|
Performance Qualification (PQ) |
Documented verification
that the process and/or the total process related system performs as
intended throughout all anticipated operating ranges. |
|
Performance Verification (PV) |
A service offered by
Hewlett-Packard’s Analytical Products Group support organization. It
verifies that the system at the user's site performs according to
the specifications as agreed between the vendor and the purchaser.
Chromatographic performance specifications are published in the
vendor's specification sheets. Chromatographic instrument hardware
specifications include baseline noise and precision of retention
times and peak areas. |
PES
|
Production Executed System |
|
Pharmaceutical Research and Manufacturers of America (PhRMA) |
- Pharmaceutical Research and Manufacturers of America (PhRMA)
Web site includes:
- Science and regulatory information
- Discussions of current issues in the pharmaceutical industry
i.e. legislation, patent protection, international harmonization
- New medicines on development database allows you to search
for information about medicines in development by disease,
indication, or drug names
- Publications, i.e., 1998 Industry Profile
|
|
Pharmacopoeia |
Official compilation of
medicinal substances and/or articles with descriptions, tests and
formulas for preparing them, selected by a recognized authority. The
pharmacopoeia issued for a country is the legal standard of that
nation. Also spelled pharmacopoeia. See official compendium. |
| PHARMA |
Pharmaceutical Research
and Manufacturers of America,
formerly PMA |
| PIC |
Pharmaceutical Inspection
Convention |
| PIC/S |
Pharmaceutical Inspection
Convention Scheme (revised 1996), a multinational organization
(primarily of European countries) whose members have agreed to
mutual recognition of facility inspections for good manufacturing
practice. |
| PICSVF |
UK pharmaceutical industry
computer systems validation forum. |
PKI
|
Public key infrastructure.
A proposal to provide a structure for verifying and authenticating
users involved in transactions on the Internet or on corporate
intranets and extranets.
The proposal involves a set of trusted certificate authorities (CAs)
who would publish a person's public key and vouch for the
authenticity of the data using a digital signature or certificate.
Other CAs would then vouch for those CAs, and they in turn would be
vouched for by other CAs.
(Ref: Dyson, Dictionary of Networking) |
| PLA |
Product license
application |
| Plant
Preparations |
Herbal ingredients present
in a form other than the crude medicinal plant material including
powdered plant material, balsams, dried and fluid extracts,
tinctures; essential oils, fatty oils, gums and resins, expressed
juices prepared from plant material, and preparations obtained by
fractionation, purification or concentration, without chemically
defined isolated constituents regardless of whether or not its
therapeutically active constituents have been identified |
| PLC |
Programmable Logic
Controller |
| PMA |
1) Pharmaceutical
Manufacturers Association in the United States. A trade association
that represents more than 100 firms, collectively producing more
than 90 percent of American prescription drugs.
now called PhRMA
2) Pemarket approval |
| Precision |
The degree of agreement of
a measured value with other values recorded at the same time, or in
the same place or on similar instruments. Also referred to as
repeatability. |
|
Proficiency testing |
Determination of
laboratory testing performance by means of interlaboratory test
comparisons.
A systematic testing program in which samples are analyzed by a
number of laboratories to measure the competence to undertake
certain analyses |
|
Prospective validation |
Establishing documented
evidence that a system does what it purports to do based on a
validation plan. |
|
Prototyping |
An approach to accelerate
the software development process by facilitating the identification
of required functionality during analysis and design phases. A
limitation of this technique is the identification of system and
software problems and hazards. |
| Proxy
server |
One type out of three
common internet gateways. Acts as an intermediate between trusted
and nontrusted networks. It receives an internal request for
Internet access and passes those requests on to the Internet (Ref.:
Reeves, Netwok+) |
| PTM |
Post Translational
Modifications |
| PTS |
Proficiency Testing Scheme |
| Public key
encryption |
An encryption scheme that
uses two keys. In an e-mail transaction, the public key encrypts the
data, and a corresponding private key decrypts the data. Because the
private key is never transmitted or publicized, the encryption
scheme is extremely secure.
For digital signatures, the process is reversed; the sender uses the
private key to create the digital signature, which can then be read
by anyone who has access to the corresponding public key. This
confirms that the message really is from the apparent sender.
(Ref: Dyson, Dictionary of Networking) |
| QA/QC |
Quality Assurance/Quality Control, the testing,
documentation and enforcement of product quality; a company's
department that performs that function; including product release. |
| QAU |
Quality Assurance Unit |
| QC |
Quality Control |
| QERP |
Quality Electronic Records Program |
| QP |
Qualified Person |
| Qualification |
Action of proving that any equipment works
correctly and actually leads to the expected results. The word
validation is sometimes widened to incorporate the concept of
qualification. |
| Quality assurance |
A set of activities, often performed by
employees in a similarly named department, that check that the
characteristics or qualities of a product actually exist at the time
the product is sold. Oversight function that audits operations to
determine that procedures and systems are suitable and recommends
required changes to provide evidence that the quality function is
functioning correctly. QA is involved from product concept through
design, manufacture and distribution until the ultimate use of the
product by the patient. |
| Quality control |
Day to day control of quality within a company,
responsible for the acceptance or rejection of incoming raw
materials and packaging components, in-process tests, labeling, and
inspection, assurance that systems are being controlled and
monitored, and for the approval or rejection of finished dosage
forms. A laboratory-based function. |
| Query language |
In a database management system, a programming
language that allows a user to extract and display specific
information from a database.
Structured Query Language (SQL) is an international database query
language that allows the user to issue high-level commands or
statements, such as SELECT or INSERT, to create or modify data or
the database structure.
(Ref: Dyson, Dictionary of Networking) |
| QMS |
Quality management system |