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Glossary O - Q

O
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.
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.
P
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)
Q
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
QbD Quality by Design
A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. (ICH Q8)
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