O
On-line
Measurement where the sample is diverted from the manufacturing process and not returned to the process stream. [Guideline on Process Validation for Finished Products, EMA]
Ongoing / Continued Process Verification
Documented evidence that the process remains in a state of control during commercial manufacture. [Guideline on Process Validation for Finished Products, EMA]
Open Isolator System
Are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing cGMP, FDA]
Open SystemAn environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. [21 CFR Part 11, FDA]
A blood collection and/or processing system which has been breached but where every effort is made to prevent external contamination by using sterilised materials and aseptic handling techniques in a clean environment. [Canadian GMP Guidelines, Annex 14]
Operating Environment
Those conditions and activities interfacing directly or indirectly with the system of concern, control of which can affect the system’s validated state. [PIC/S PI 011-3]
Operating Limit
The minimum and/or maximum values that will ensure that product and safety requirements are met. [Main Principles for Pharmaceutical Products, WHO]
Operating Range
The range of validated critical parameters within which acceptable products can be manufactured. [Main Principles for Pharmaceutical Products, WHO]
Operating System
A set of software programs provided with a computer that function as the interface between the hardware and the applications program. [PIC/S PI 011-3]
Operational Condition(see also In Operation)
This condition relates to carrying out room classification tests with the normal production process with equipment in operation, and the normal staff present in the room. [Main Principles for Pharmaceutical Products, WHO]
Operational Qualification (OQ)
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. [EU GMP Guide, Annex 15]
The documented verification that the system or sub-system performs as intended throughout all anticipated operating ranges. [PIC/S PI 006-3]
The documented action of demonstrating that process equipment and ancillary systems work correctly and operate consistently in accordance with established specifications. [Canadian GMP Guidelines 2009]
Operator
Any individual participating in the aseptic processing operation, including line set-up, filler, maintenance, or other personnel associated with aseptic line activities. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Order(commande) Instruction to process, package and/or ship a certain number of units of investigational medicinal product(s). [EU GMP Guide, Annex 13, Canadian GMP Guidelines 2009, Annex 13, Specific Pharmaceutical Products, WHO]
Out of Specification (OOS)
Includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer.
Outsourced ActivityActivities conducted by a contract acceptor under a written agreement with a contract giver. [ICH Q10]
Over-the-Counter Drug
These are drugs that can be sold from licensed dealers without professional supervision and without prescriptions. These drugs are suitable for selfmedication for minor diseases and symptoms. [Inspection, WHO]
Overkill Sterilization Process
A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minimum D value of 1 minute. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Measurement where the sample is diverted from the manufacturing process and not returned to the process stream. [Guideline on Process Validation for Finished Products, EMA]
Ongoing / Continued Process Verification
Documented evidence that the process remains in a state of control during commercial manufacture. [Guideline on Process Validation for Finished Products, EMA]
Open Isolator System
Are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing cGMP, FDA]
Open SystemAn environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. [21 CFR Part 11, FDA]
A blood collection and/or processing system which has been breached but where every effort is made to prevent external contamination by using sterilised materials and aseptic handling techniques in a clean environment. [Canadian GMP Guidelines, Annex 14]
Operating Environment
Those conditions and activities interfacing directly or indirectly with the system of concern, control of which can affect the system’s validated state. [PIC/S PI 011-3]
Operating Limit
The minimum and/or maximum values that will ensure that product and safety requirements are met. [Main Principles for Pharmaceutical Products, WHO]
Operating Range
The range of validated critical parameters within which acceptable products can be manufactured. [Main Principles for Pharmaceutical Products, WHO]
Operating System
A set of software programs provided with a computer that function as the interface between the hardware and the applications program. [PIC/S PI 011-3]
Operational Condition(see also In Operation)
This condition relates to carrying out room classification tests with the normal production process with equipment in operation, and the normal staff present in the room. [Main Principles for Pharmaceutical Products, WHO]
Operational Qualification (OQ)
The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges. [EU GMP Guide, Annex 15]
The documented verification that the system or sub-system performs as intended throughout all anticipated operating ranges. [PIC/S PI 006-3]
The documented action of demonstrating that process equipment and ancillary systems work correctly and operate consistently in accordance with established specifications. [Canadian GMP Guidelines 2009]
Operator
Any individual participating in the aseptic processing operation, including line set-up, filler, maintenance, or other personnel associated with aseptic line activities. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Order(commande) Instruction to process, package and/or ship a certain number of units of investigational medicinal product(s). [EU GMP Guide, Annex 13, Canadian GMP Guidelines 2009, Annex 13, Specific Pharmaceutical Products, WHO]
Out of Specification (OOS)
Includes all suspect results that fall outside the specifications or acceptance criteria established in new drug applications, official compendia, or by the manufacturer.
Outsourced ActivityActivities conducted by a contract acceptor under a written agreement with a contract giver. [ICH Q10]
Over-the-Counter Drug
These are drugs that can be sold from licensed dealers without professional supervision and without prescriptions. These drugs are suitable for selfmedication for minor diseases and symptoms. [Inspection, WHO]
Overkill Sterilization Process
A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minimum D value of 1 minute. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]