Transfer of Technology – Terminologies
Measurable terms under which a test result will be considered acceptable.
Bracketing is an experimental design to test only the extremes of certain design factors (e.g., dosage, strength). The design assumes that the extremes will be representative of all the samples between the extremes.
Change Control (C/C):
Change control is a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated statue. The intent is to determine the lead for action that would ensure that the system is maintained in a validated stage.
The setting up, adjustment and testing of equipment or a system to ensure that is meets all the requirements as specified in the user requirement specifications and capacities as specified by the designer or developer. Commissioning is carried our before qualification and validation.
A planned set of controls, derived from current product and process understanding that assures process performance and product quality. The control can include parameter and attributes related to material and components related to drug substances and drug product materials, facility and equipment operating conditions, in process content, finishing product specifications and the associated methods and frequency of monitoring and control.
Corrective Action (C/A):
Corrective action is any action to be taken when the result of monitoring at a critical control point indicate a loss of control.
Critical Control Point (CCP):
Critical control point can be defined as a step at which control can be applied and is essential to prevent or eliminate a pharmaceutical quality hazard or to reduce it to an acceptable level.
Critical can be defined as a condition having the potential to impact an product quality or performance in a significant way.
Design Qualification (DQ):
Design qualification is the document evidence that the premises, supporting systems, utilities, equipment and processes have been designed in accordance with the requirements of GMP.
Drug Master File (DMF):
DMF or Drug Master File is teh detailed information regarding a specific facility, process, or product submitted to the medicine regulatory authority intended for incorporation into the applied for marketing authorization.
Finished Pharmaceutical Product (FPP):
FPP or Finished Pharmaceutical Product can be defined as a product that has undergone all stages of production including packaging in its final container and labelling. An FPP may contain one or more APIs.
Sending Unit (SU):
The involved discipline at an organisation from where a designated product, process or method is expected to be transferred.
Receiving Unit (RU):
The involved disciplines at an organisation where a designated product, process, or method is expected to be transferred.
Identification of critical element of a process which are available at the SU but ate missing from the RU.
Installation Qualification (IQ):
The performance of tests to ensure that the installations used in a manufacturing process are appropriately selected and correctly installed and operate in accordance with stablished specifications.
Transfer of technology from one company to another company.
Transfer of technology from one branch of a company to other branch of same company.
Operational Qualification (OQ):
Document verification that the system or sub-system performs as intended over all anticipated operating ranges.
Performance Qualification (PQ):
Document verification that the equipment or system operates consistently and gives reproducing with in defined specification and parameter for prolonged period.
Process Validation is defined as the collection and evaluation of data, from the process, design stage throughout the production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
Those batches reduced by the RU to demonstrate its ability to reproduce the product.
Quality assurance is defined as the sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient.
Quality control is defined as the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical product.
Quality Planning is the part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil the quality objectives.
Quality Policy is the overall intentions and direction of an organization related to quality as formally expressed by senior management.
Quality Risk Management (QRM):
Quality Risk Management is a systematic process for the assessment, control, communication, and review of risks to the quality of the pharmaceutical product throughout the product lifecycle.
Spiking can be defined as the addition of unknown amount of a compound to a standard sample or placebo topically for the purpose of conforming the performance of an analytical procedure.
Standard Operating Procedure (SOP):
A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to carry out the operations correctly and always in the same manner. A SOP should be available at the place where the work is done.
Technology Transfer Report:
Technology transfer report is a documented summary of a specific technology transfer project listing procedure, acceptance criteria, results achieved and conclusions. Any deviation should be discussed and justified.
Validation is the act of confirming something as true or correct. The establishing documented evidence that provide high degree of assurance that specific process will consistently produce a product meet its predetermined specification and quality attributes.
Validation Master Plan (VMP):
Validation Master Plan or VMP outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility.A high level document that establishes an umbrella validation plan for the entire project and summarises the manufacturer’s overall philosophy and approach to tbe used for establishing and approach to be used for establishing performance adequacy.
Validation Protocol/Plan (VP):
Validation Protocol is a written plan describing the process to be validated, including production equipment and how validation will be conducted. A Validation Protocol is necessary to define the specific items and activities that will constitute a cleaning validation study.
A validation report is a document that summarizes all validation results and procedures done in order to ensure that certain products and services consistently maintain satisfactory quality.