C Service
C Service (Critical)
When your first ship date is rapidly approaching and a working Standard Operating Procedure (SOP) is adequate for your type of product, LifeConEx C Service is the way to go. A working SOP and incident report are available. The C Service requires a minimum of 3 business days for implementation prior to the first ship date of your product.
Calibration
Calibration
The tuning of an instrument according to a standard value.
Calibration Verification
Calibration Verification
The act of confirming that a device or instrument is properly calibrated.
Cardboard
Cardboard
A thick paper-based material.
Carrier
Carrier
Provides transport services for traveling passengers and/or freight.
Carry Paks
Carry Paks
A thermal container system with a handle that makes personal transportation easy and efficient. Ideal for medical samples, food, perishables, or valuables (also called carry packs).
CFC
CFC
Chlorofluorocarbons - a refrigerant known to cause depletion of atmospheric ozone.
CFR
CFR
Code of Federal Regulations
CFR (21) Part 11
CFR (21) Part 11
Federal regulations stating that electronic records and signatures are considered equivalent to paper records.
cGMP
cGMP
Current Good Manufacturing Practices
Chamber Controller
Chamber Controller
An electronic instrument used to regulate the ambient temperature of an environmental chamber.
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Change Control
Change Control
Process, authorities, and procedures used for all computerized or system data changes. Change control should be in place to ensure that changes are reviewed for potential impact upon the quality of the product or upon the quality system. Source: WHO TRS 937 Annex 5, 12.2. EU GMP Part 1, 8, ICH Q10 3.2.3
Chart Recorder
Chart Recorder
An electronic instrument that records the ambient temperature of an environmental testing chamber.
Chilled
Chilled
Usually products in this category need to be stored and distributed at 2° and 8° C. The building or fridge should be alarmed so that potential deviations can be acted upon. Appropriate insulation and access control should be in place so that temperature fluctuations do not occur. Source: EU GMP 1 3.3, PIC/s PE009-7 Part I 3.3, HQMS AA-4 08
Clinical Investigation
Clinical Investigation
Any experiment in which a drug is administered or dispensed to or used involving one or more human subjects. For the purpose of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. (FDA Regulation 312.3, Investigation New Drug Application).
Clinical Research
Clinical Research
Patient oriented research including epidemiology (retrospective, cross-sectional, or prospective study of disease(s) in populations), and studies of behaviors, outcomes, and health services.
Clinical Site
Clinical Site
A clinical site is a medical facility staffed with a clinical investigator (MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to.
Clinical Trial
Clinical Trial
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or pharmacodynamic effects of an investigational product with the object of determining safety and/or efficacy." (ICH GCP, International Conference on Harmonization / WHO Good Clinical Practice Standard)
Clinical Trial Volunteer
Clinical Trial Volunteer
Individuals who are participating in a clinical research study.
CO2 Emissions
CO2 Emissions
Carbon dioxide (CO2) is emitted in a number of ways. It is emitted naturally through the carbon cycle and through human activities like the burning of fossil fuels.
Cold
Cold
Any temperature not exceeding 8° C; (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° C; and 8° C; (36° and 46° F). (USP 797)
Cold Chain Analytics
Cold Chain Analytics
A solution that drives the day-to-day retrieval, storage, compilation, analysis and reporting of your cold chain data. Temperature data, gathered from your cold chain, is translated into pertinent, meaningful information that allows managers to reduce costs, improve quality and increase profitability.
Cold Chain Management
Cold Chain Management
Management of all phases of the cold chain, including products in transit, in process, in storage, and in display.
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Cold Chain Network
Cold Chain Network
See Cold Chain.
Cold Chain Packaging Consultant
Cold Chain Packaging Consultant
An individual with expertise in the area of cold chain packaging.
Cold Chain Product
Cold Chain Product
A product that is temperature sensitive.
Cold Chain Solutions
Cold Chain Solutions
Are designed to achieve the goal of consistently having temperature-sensitive medicinal products in the right place, at the right time, and in the right condition, through the integration of monitoring, and tracking and tracing, with an emphasis on driving measurable process improvement from the information.
Cold Chain Storage Consulting
Cold Chain Storage Consulting
Advice from an expert in the design and application of cold chain solutions.
Cold Chain
Cold Chain
Refers to a time and temperature controlled transportation for temperature sensitive products from the manufacturer to the end user. Source: PDA PCCIG EU Branch Lead, Berlin PDA 2010
Conditioning
Conditioning
see Pre-conditioning.
Conductive Heat Transfer
Conductive Heat Transfer
Having the quality or power of conducting heat or electricity or sound; exhibiting conductivity.
Consignee
Consignee
In a contract of carriage, the consignee is the person to whom the shipment is to be delivered to whether by land, sea or air.
Container
Container
The material employed in the packaging of a pharmaceutical product. Containers include primary and secondary containers. Containers are referred to as primary if they are intended to be in direct contact with the product. Secondary containers are not intended to be in direct contact with the product. Source: WHO TRS 937 Annex 5
Contamination
Contamination
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter during manufacturing, sampling, packaging or repackaging, storage or transport. Source: WHO TRS 937 Annex 5
Contingency Planning
Contingency Planning
One of the fundamental aspects of LifeConEx Process Management. Multiple storage and distribution options are built into the cold chain to ensure an uninterrupted process which maintains a given temperature range.
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Controlled Ambient Temperature
Controlled Ambient Temperature
Some regions and products need both monitoring and control because of severe temperature fluctuations. Controlled ambient is understood as between 15C and 30C and needs to be validated. Source: EU GMP Part 1 3.19, HQMS AA-4 08, Pharma 2001: 267: 128-131
Controlled Drug Storage
Controlled Drug Storage
An additional license is required to store controlled drugs. A separate secure storage area should be provided which is designed to meet local regulatory security requirements. Source: HQMS AA4-10, INCB Yellow & Green Lists
Controlled Room Temperature (CRT)
Controlled Room Temperature (CRT)
A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours. Spikes above 40°C may be permitted if the manufacturer so instructs. Articles may be labeled for storage at "controlled room temperature" or at "up to 25°C", or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variations. (Source: USP 797)
Convective Heat Transfer
Convective Heat Transfer
Caused or accomplished by convection; as a convective discharge of electricity.
Cool
Cool
Any temperature between 8° C; and 15° C; (46° and 59° F). An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph. (Source: USP 797)
Corrective Action
Corrective Action
Is taken to eliminate the cause of a detected non-conformity or other undesirable situation.
Corrective Action Preventive Action (CAPA)
Corrective Action Preventive Action (CAPA)
focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action). To ensure that corrective and preventive actions are effective, the systematic investigation of the failure incidence is pivotal in identifying the corrective and preventive actions to be undertaken. A formal written response must be made by the facilities audited on all observations within 30 days. CAPA is part of the overall quality management system (QMS) at LifeConEx called - LifeControl.Source: Good Manufacturing Processes, ISO 13485:20038.3, ICH Q10 3.2.2, FDA 21 CFR 820.90
Corrugate
Corrugate
Refers to the alternating ridges and grooves in a cardboard carton.
Counterfeit Medication
Counterfeit Medication
Product or cosmetic which is deliberately and fraudulently mislabeled with respect to identify and/or source. Counterfeiting can apply to both branded and generic products/cosmetics and may include products / cosmetics with the correct ingredients or with wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. Source: Guidelines for Good Distribution Practice
Cross-contamination
Cross-contamination
Contamination of a starting material, intermediate product or finished product with another starting material or product during production. Source: Source: WHO TRS 937 Annex 5
Customs
Customs
Each country's department that reviews in-coming materials, including clinical trials materials. The area at a port, airport, or border where baggage and freight are examined for duty status. Care must be taken with temperature sensitive materials and prior notification should be provided so that speedy clearance can be obtained and if necessary the correct storage conditions provided for at the point of entry. Source: EU GDP (94/C – 63/03) 21, WHO TRS 937 Annex 5 18.6
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