Glossary

The outsourcing of all, or part of a company's supply chain management functions, e.g. warehousing, fulfillment, and/or transportation services, to a third party company. Komtur doesn’t use 3PL - we offer comprehensive solutions, tailor-made to each project - storing and shipping products on your behalf, allowing our clients to benefit from lower shipping / inventory costs and faster delivery times through efficient control and stock management.

An ingredient in a pharmaceutical drug that has an effect on the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body of humans or animals.

Any medicines designed for human use that are based on cells, gene, tissue-engineered and somatic-cell therapy medicines.

Storage of a product within a temperature range of 15 - 24°C / 59 - 75°F, for which neither heating or refrigeration is normally required

Accessories such as syringes, sterile napkins etc tubes required for the purpose of administering a specific medicine.

A product that has been manufactured in compliance with the national and regional regulations and legislation of a specific country. Medical products with or without registration and/or licence can also be marketed and distributed at the discretion of the national or regional regulatory authorities.

Collection of a quantity of any drug produced during a given cycle of manufacture, during which the manufacturing conditions are stable and have not been modified, to enable consistent testing in a trial.

Technology based on biology - the manipulation of organisms or components of a biological system to create new products or processes.

This involves studying the physical, genetic, and chemical characteristics of cells and tissues and exploring industrial applications for them.

Shortages caused by problems in the supply chain, These have been exacerbated considerably by events since 2019, including Brexit, the COVID-19 pandemic and the war in Ukraine.

The active ingredient in a biologic drug.

Inserting new, healthy cells into the body to replace diseased or damaged ones, or the removal of disease-causing or dysfunctional cells using immune cells.

The Current Good Manufacturing Practice regulations intended to assure proper design, monitoring and control of manufacturing processes and facilities to ensure that drug products are safe for use, and have the ingredients and strength they claim to have.

This includes setting up strong quality management systems, sourcing raw materials of the appropriate quality, building robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories to prevent instances of contamination, mix-ups, deviations, failures, and errors.

A production facility or a clinical trial materials pilot plant for the manufacture of pharmaceutical products, using technologies and systems that are up to date and comply with GMP regulations.

Current Good Manufacturing Practices Training covers all aspects GMP regulations.

A clinical research process designed to generate high-quality, reliable, complete and statistically sound data from clinical trials, to ensure that conclusions drawn are well supported by the data.

It ensures the collection, integration and availability of error-free data at appropriate quality and cost.

The process where clinical trial sponsors bring in outside expertise from another company to take the lead in managing that company’s trials and complex medical testing responsibilities. This can help reduce the cost of research and development.

The comprehensive study of the safety and effectiveness of the most promising advances in patient care,testing drugs, devices, tools, diagnostic tests, techniques and technologies on human volunteers prior to their licensing for use in medicine.

The supply of materials needed for conducting a clinical trial - including 24-hour collection and delivery of investigational drugs, kits and other study materials, and biological specimens (including infectious samples), along with all permit applications including import permits, Ministry of Health authorizations, etc., customs clearance including pre-clearance (whenever possible) to expedite delivery, cold chain services including temperature-controlled packaging, supplies and expertise.

The series of logistics partners involved in the world-wide distribution of everything from raw materials right through to delivering end products to the patient. Key business units include: manufacturing, packaging, pharmacy, quality, regulatory, clinical and analytics.

Non-medicinal products and other study-related drugs required in clinical trials, such as diagnostic, testing and medical equipment; centrifuges; disposable products; refrigerators; computers; eDiaries and ECG machines.

Medical research involving human volunteers - the primary way that researchers find out if a new treatment, drug or medical device is safe and effective in for human use. There are two types, observational studies and clinical trials.

A supply chain for sensitive pharmaceutical drugs and biological materials conducted in end-to-end temperature control through transit (usually within the range of 2 – 8 degrees).

Temperature-controlled environments used to store, manage and transport pharmaceutical drugs and biological materials which need to be kept within a limited temperature range from the time they are manufactured until the moment of use.

Temperature-controlled vehicles used for the transit of pharmaceutical drugs and biological materials which need to be kept within a limited temperature range from the time they are manufactured until the moment of use.

A comparator is an investigational or marketed product (active control) or placebo (inactive control) used as a reference in a clinical trial. The term also refers to investigational medicinal products when the drugs are intended to be manufactured, repacked, or used outside of their registered indications.

The process of locating and procuring a comparator drug for a clinical trial.

A treatment option that allows the use of an unauthorised medicine to be given to patients with serious or life-threatening conditions, for which there are no other suitable treatments.

The responsibility of medicine developers to ensure that they (and any partners) comply with standards and regulations set out in an approved marketing authorization.

A supply chain model in which a product is sold by a retailer, but ownership is retained by the supplier until the product has been sold. Because the retailer does not actually pay for the inventory until it has been sold, unsold products can be returned.

A drug or other substance that could be abused or cause addiction, and is thus subject to tight government regulations covering the way it is made, used, handled, stored, and distributed.

Storage in the range of 2 - 8°C / 35 - 46°F.

The Current Good Manufacturing Practice regulations, which assure proper design, monitoring, and control of manufacturing processes and facilities.

Storage at -20°C / -4°F.

A system that identifies, stores and tracks all documents related to the development, production and distribution of pharmaceutical products.

Medications manufactured and used to diagnose, cure, treat, or prevent disease.

The therapeutic effectiveness of a drug/ the degree to which it has produced the effects planned.

An agency of the European Union with responsibility for the evaluation and supervision of medicinal products, and for standardizing these products at EU level. Before 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency.

The approval of a centralised Marketing Authorisation Applications (MAA) by The European Medicines Agency. Once granted by the European Commission, this authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

The responsibility of all organisations involved in the development, marketing, manufacture and distribution of veterinary medicines to ensure that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals.

The body responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

The FDA also carries responsibility for helping to expedite innovations that make medical products safer, more effective and more affordable and disseminating accurate, science-based information to help the public make decisions in using medical products and foods to improve and maintain their health.

A document covering the FDA's interpretation of regulatory issues around. The design, production, labeling, promotion, manufacturing and testing of regulated clinical products.

Approval for clinical use means that data on the drug's effects lab, animal, and human clinical testing have been reviewed by the FDA, who have determined that the drug’s benefits outweigh any known and potential risks for the intended population.

The responsibility of a manufacturer to follow FDA regulations to ensure the safety, efficacy, and security of drugs, medical devices, and biological products, and to manufacture the product to the prescribed quality standards.

The minimum standards that a wholesale distributor must meet to maintain the quality and integrity of medicines throughout the supply chain.

A medical approach that treats or prevents disease by delivering a functioning gene to targeted tissue, correcting the underlying genetic problem used to treat a variety of diseases, including genetic disorders, cancer or long-term diseases.

The genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material.

The minimum standard that a medicines manufacturer must meet in their production processes, to ensure products are of consistent high quality, appropriate to their intended use and meet the requirements of the Marketing Authorisation (MA) or product specification.

Good Manufacturing Practice (GMP) - the minimum standard that a pharmaceutical manufacturer has to maintain in their production processes, to ensure products are of consistent high quality and appropriate to their intended use.

A production facility or a clinical trial materials pilot plant where pharmaceutical products are manufactured.

An essential requirement to ensure everyone who works for a pharmaceutical manufacturer meets the minimum standards of Good Manufacturing Practice (GMP) in their production processes.

The minimum standards that a wholesale distributor must meet to maintain the quality and integrity of medicines throughout the supply chain.

Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain. Komtur can perform these imports with QP release.

The regulated and legally-compliant transport of licensed or unlicensed drugs from another country directly to a specific, single patient, under an Individual Import License from the local authority.

A nonprofit association serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle.

Any medicinal product being used or tested as a reference in a clinical trial - including newly-developed drugs, but also licensed drugs being tested against a new condition, or in a new formulation or packaging, or which are being used to gather more information about the authorised form.

A financial service Komtur provides certain clients for wholesale or pre-wholesale projects where we invoice the customers on our clients behalf.

A company (usually Pharma manufacturer), firm or non-profit organisation that has been granted a Marketing Authorisation enabling it to market a specific medicinal product in a specific country. In the EU, MAH can be granted centralized or de-centralized marketing authorization. Komtur can also help with the transfer of MAH in the event one company sells a product to another.

A program under which Investigational Medicines are used to treat specific patients affected by life-threatening, long-lasting or seriously debilitating illnesses.

The process of ensuring that all eligible patients receive rapid, consistent and sustained access to those medicines, devices or services which have marketing authorization - and ensuring those medicines, devices or services are fairly priced and reimbursed.

The first market introduction of a medicinal product.

Any instrument, machine, appliance, implant, apparatus, implement, reagent for in vitro use, software, material or other similar or related article, manufactured for a medical purpose.

A chemical or compound used to treat prevent disease; ease symptoms; or help in the diagnosis of illnesses.

A program in which a patient is given specific access to a post-approval drug that is approved and commercially available in a country other than their home country.

Substances used to treat moderate to severe pain, including opiates such as morphine and codeine, that are not made from opium. Narcotics are now called opioids.

A company's end-to-end order processing system, from the moment a customer places an order to the final delivery and payment, but excluding branding, marketing, or sales.

A medicine for the diagnosis, prevention or treatment of a rare (affecting less than five in 10,000 people), life-threatening or chronically debilitating condition that is unlikely to generate enough profit to justify research and development costs.

The covering to a pharmaceutical product that protects the product during handling, storage and transportation and enables the clear, unambiguous identification of the medicine and the conditions for its safe use.

The containment packaging that comes into direct contact with the product and is often referred to as retail packaging or POS (Pointof-Sale) Packaging. The main purpose of primary packaging is to preserve the product as well as inform the consumer - ampoules, vials, bottles, tubes, blister pack

A means of enabling patients to access high cost drugs and treatments through innovative pricing agreements.

A program in which which pharmaceutical companies can reduce the cost of a medicine, enabling patients to gain access to high cost medicine treatments, sometimes referred to as risk share schemes or market access schemes.

A written, printed or graphic matter upon any drug or drug container that enables the clear, unambiguous identification of the medicine and the conditions for its safe use.

The packages and the packaging processes for pharmaceutical preparations, including all of the operations from production through drug distribution channels to the patient.

The expert, regulated and legally-compliant transport of licensed or unlicensed drugs into a country, taking account of the necessary import documentation and customs clearance procedures of the importing country.

The legally-compliant and regulated sourcing of licensed or unlicensed drugs from one country to another, taking account of the necessary import documentation and customs clearance procedures of the importing country.

The promotion of drugs and medical devices to healthcare professionals (HCPs) and medicine users.

The intermediaries between pharmaceutical manufacturers and retailers who facilitate the delivery of the right medicines in a timely, efficient, and secure manner.

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs.

Chemical compounds manufactured for use as a medicinal drug.

The “drug safety” process relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects of licensed pharmaceutical products, to identify and evaluate previously unreported adverse reactions.

First testing in humans, primarily to test safety. A drug is given to a small number of healthy volunteers who are closely monitored to ascertain the safety, side effects, best dose, and timing of a new treatment.

Testing in a small number of patients, to assess how safe the treatment is, how it is metabolized and how well it works.

A large, often randomized trial in patients to compare the safety and effectiveness of the new treatment against the current standard treatment, providing the key data on efficacy in submissions for regulatory approval.

Studies carried out after a drug has been licensed, involving thousands of participants, to gather further safety, efficacy or effectiveness data in routine clinical use. This phase can last for many years.

A substance or treatment that looks identical to, and is given the same way as, an active drug or treatment being tested, but is designed to have no therapeutic effect. The effects of the active drug or other intervention are compared to the effects of the placebo.

A way that patients with life threatening or seriously debilitating conditions can be given early ethical, compliant, and controlled access to new medicines that do not yet have a marketing authorization.

Logistical services supplied to pharmaceutical manufacturers, including the warehousing and transportation of pharmaceutical products from the manufacturer to wholesalers, hospitals and sometimes to pharmacies.

The process of acquiring supplies to ensure the supply of required materials under consideration of all legal regulations.

Direct Procurement is spending on services, goods, and materials that drive profit, performance, and competitive advantage.

Whereas indirect procurement is expenditure on the maintenance, goods, and services needed for day-to-day operations.

A supply issue or lack of product availability which can have a number of causes, including manufacturing and quality problems, delays, and discontinuations.

Any drug that affects behavior, mood, thoughts, or perception including antidepressants, anti-anxiety medications, stimulants, antipsychotics, and mood stabilizers.

A key step to introducing a medical product into a country, designed to orotect public health, preventing the marketing of poor quality and dangerous medicines and enabling the distribution of effective and safe medicines.

The process of ensuring that pharmaceutical products are manufactured to a safe and consistent standard. The entire process is constantly monitored and updated to ensure consistency and compliance, from the procurement of raw materials to manufacturing,.

Qualified Persons (QP) play a critical role in bringing safe, timely products to the market, and must be aware of the complex interplay of regulations and environment in their destination country.

A QP must certify the supply of medicinal products to confirm the batch has been compliantly manufactured.

QP legal responsibility is defined by the EU Clinical Trial Directive (2001/20/EC) which makes them accountable from manufacture to end-user.

Komtur’s QPs make it possible for us to perform a range of services, for example in the UK the facilitate the import and export of supply unlicensed specials, even pre-notiying the NHRA on our clients behalf.

During clinical trials our QPs ensure each batch of investigative medicinal products (IMPs) has been manufactured to a high enough standard to be released for the study.

The voluntary removal of a defective or potentially harmful drug product from the market by the manufacturer.

Sometimes the local health authority will request a recall following reports of problems from the public.

The scientific framework of standards for getting high quality, safe and effective medicines to patients.

A body with the power to authorise medicines which is:

• a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), i.e. the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or
• an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or
• a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).”

Any medicine designed to relieve symptoms immediately, most often used for severe allergies, for asthma, or for migraines.

The scientific process for the development of new medicines.

Komtur can manage returns and destruction of your product according to your company and regulatory requirements, and we’ll store excess amounts of study drugs or drugs past their expiry date.

A Generally Accepted Accounting Principle (GAAP) that dictates when and how businesses “recognize” or record revenue in their books, following the ‘5-step model’.

1. Identify the Contract with Your Customer.
2. Identify Your Performance Obligations.
3. Determine Your Transaction Price.
4. Allocate the Transaction Price to the Performance Obligations in the Contract.
5. Recognize Revenue When Your Business Satisfies a Performance Obligation.

The European GDP Guideline of 5 November 2013 requires that wholesale distributors have to appoint a Responsible Person (RP) for GDP.

The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices and:

• ensures the provisions of the licence are observed
• ensures that operations do not compromise the quality of medicines
• ensures an adequate quality system is established and maintained
• oversees audits of the quality system and carries out independent audits
• ensures adequate records are maintained
• ensures all personnel are trained
• ensures full and prompt cooperation with product licence holders in the event of recalls.

The outer packaging which houses the primary packaging and does not come into direct contact with the product.

The shipment packaging which protects the product in transit – this may include cold packs and excursion loggers to ensure product integrity.