Pharmaceutical Compliance Glossary

The US FDA's premarket-notification pathway, named after section 510(k) of the Federal Food, Drug, and Cosmetic Act. A 510(k) clearance is one of the documents PPB accepts as Reference Regulatory Authority approval.

Adverse Drug Reaction. A response to a medicine that is noxious and unintended and occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy. Suspected ADRs should be reported to the Pharmacy and Poisons Board through its pharmacovigilance reporting channels, and they form the basis of ongoing safety monitoring.

An acronym for Attributable, Legible, Contemporaneous, Original, and Accurate. A set of principles ensuring data integrity in pharmaceutical quality management, critical for regulatory compliance in Kenya.

Active Pharmaceutical Ingredient. The biologically active component of a drug product that produces the intended therapeutic effect.

A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

Documents that provide a history of each batch of product and of all circumstances pertinent to the quality of the final product.

The date after which a compounded or repackaged preparation should not be used, counted from the date it was prepared or first opened rather than from the date of manufacture. It differs from the manufacturer's expiry date and reflects the shorter stability of an opened or compounded product. It should be assigned using stability data and recognised pharmacy standards. Often abbreviated BUD.

Batch Manufacturing Record. A document that provides the history of a batch, including details of materials, processes, and controls used during its production.

Batch Packaging Record. A document detailing the packaging process of a pharmaceutical batch, including materials used, equipment, and quality checks, as required by Kenyan regulatory standards.

Corrective and Preventive Action. A systematic approach to identifying, addressing, and preventing the recurrence of quality issues in pharmaceutical manufacturing and quality control, as required by Kenyan regulations.

A formal process used to ensure that changes to a product, process, or system are introduced in a controlled and coordinated manner to maintain quality and compliance.

Cost, Insurance and Freight. An Incoterm under which the seller covers cost, insurance and freight to the named destination port; the standard valuation basis for Kenyan import duty and VAT.

A controlled environment with a low level of pollutants such as dust, airborne microbes, and chemical vapors, used in pharmaceutical manufacturing to prevent contamination.

Chemistry, Manufacturing, and Controls. The section of a regulatory submission to the PPB that describes the composition, manufacturing process, and quality control of a pharmaceutical product.

Certificate of Analysis. A laboratory release document confirming that a specific batch of material or product meets its specifications. Required for materials of animal, human, microbial or recombinant origin in PPB submissions.

Certificate of Conformity. The document issued by a KEBS-appointed PVoC inspection body confirming that a consignment meets the relevant standards; required at Kenyan ports of entry.

A temperature-controlled supply chain. An uninterrupted series of storage and distribution activities which maintain a given temperature range.

An action taken to eliminate the root cause of an existing nonconformity, defect, or other undesirable situation so that it does not recur. It is the reactive half of CAPA and follows the investigation of a deviation, complaint, or out-of-specification result. Corrective actions and their effectiveness checks are recorded within the pharmaceutical quality system.

A current company extract issued by Kenya's Office of the Registrar of Companies listing the directors, shareholders and registered office of a company. Required as part of the applicant pack for medical-device and medicine registrations.

Common Submission Dossier Template. The harmonised dossier format originally adopted by ASEAN and used by PPB for Class C and Class D medical-device submissions.

Common Technical Document. A standardized format for submitting applications, amendments, and supplements to regulatory authorities like the PPB for the registration of pharmaceuticals in Kenya.

A departure from approved standards, procedures, or specifications in the manufacturing or quality control process, which may or may not affect product quality.

Dental Grouping Term. A grouping classification used in PRIMS specifically for dental devices grouped under a single dental term.

Declaration of Conformity. The manufacturer's signed statement that a device meets the applicable harmonised standards (e.g. ISO, IEC, EN). Required for Class C and Class D medical-device submissions.

Drug Regulatory Authority. In Kenya, this refers to the Pharmacy and Poisons Board (PPB), which oversees the regulation of pharmaceuticals, including registration, licensing, and post-market surveillance.

Electronic Common Technical Document. The electronic format and structure for compiling and submitting the Common Technical Document to a regulatory authority. It organises quality, non-clinical, and clinical information into standard modules and supports lifecycle management of a submission over time.

European Union Medical Devices Regulation (Regulation (EU) 2017/745). The EU framework that classifies medical devices into Class I, IIa, IIb, III plus active-implantable. Accepted by PPB as a Reference Regulatory Authority basis.

United States Food and Drug Administration. Listed on PPB PRIMS as an acceptable Reference Regulatory Authority via 510(k), De Novo or PMA clearance.

First Expired, First Out. An inventory management method where products with the earliest expiry date are processed first.

First In, First Out. An inventory management method where assets produced or acquired first are used first.

Failure Modes and Effects Analysis. A risk management tool used to identify potential failure modes in a system, process, or product, assess their impact, and prioritize corrective actions.

Free On Board. An Incoterm under which the seller delivers goods on board the vessel at the named port of shipment; widely used as the basis for KEBS PVoC fee calculations.

Good Distribution Practice. Guidelines ensuring that the quality of pharmaceutical products is maintained throughout the supply chain, from manufacturer to end user, as enforced by the PPB in Kenya.

Global Medical Device Nomenclature. The international standard naming system for medical devices. Each device on PRIMS is identified by its GMDN term and code.

Good Manufacturing Practice. A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product.

Health Products Regulatory Authority. Ireland's national medicines and medical-device regulator. Accepted by PPB as a Reference Regulatory Authority.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. An initiative that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration.

Individual Case Safety Report. A structured record of a single suspected adverse drug reaction reported for one patient, capturing the patient, product, reaction, and reporter details. ICSRs are the basic unit of pharmacovigilance data and feed both signal detection and periodic safety reporting.

Import Declaration Form. The KRA / Customs document required before goods are imported into Kenya; serves as the basis for customs valuation and downstream clearance.

Instructions for Use. The user manual or patient information leaflet supplied with a medical device or medicinal product. Mandatory upload across all PPB device classes.

Information Management System. PPB's umbrella term for its online portal (PPB IMS); the version label appears on every PRIMS page (e.g. PPB IMS v3.1).

International Organization for Standardization. The body that publishes voluntary international consensus standards (e.g. ISO 13485 for medical-device quality management, ISO 14971 for risk management, ISO 10993 for biological evaluation).

Kenya Bureau of Standards. The national standards body that runs the Pre-Export Verification of Conformity (PVoC) scheme; medical devices imported into Kenya must obtain a Certificate of Conformity from a KEBS-appointed inspector before shipment.

Kenya Medical Supplies Authority. A state corporation under the Ministry of Health responsible for the procurement, warehousing, and distribution of medical supplies and pharmaceuticals to public health facilities in Kenya.

Kenya Trade Network Agency. Operates the TradeNet single-window system used for import and export documentation in Kenya. Importers register a KenTrade account before declaring an IDF.

Kenyan Shilling. The national currency of Kenya, also written as KSh on official receipts and statutory fee schedules.

Kenya Revenue Authority. The national tax authority; KRA-issued PIN certificates are mandatory in every PPB applicant pack and on import documentation.

Letter of Authorization. The manufacturer's written instruction appointing the local distributor / LTR to act on its behalf with the regulator. Mandatory upload on every PRIMS medical-device application.

Local Technical Representative. The registered Kenyan pharmacist plus locally-incorporated entity that PPB requires foreign manufacturers to appoint as their in-country regulatory point of contact.

Marketing Authorisation Holder. The legal entity that holds the marketing licence for a medicinal product or medical device in a market and bears post-market regulatory responsibilities.

A single derived temperature that expresses the cumulative thermal effect of the temperature fluctuations a product experiences over a defined period of storage or transport. It is calculated from recorded temperatures using an Arrhenius-based equation, which gives greater weight to higher temperatures because chemical degradation accelerates with heat. In Kenya it is used to judge whether cold-chain and controlled-room-temperature storage stayed within limits and to assess the impact of temperature excursions on product quality. Often abbreviated MKT.

Ministry of Health, Labour and Welfare. Japan's national medicines and medical-device authority. Accepted by PPB as a Reference Regulatory Authority.

Mean Kinetic Temperature. A single derived temperature that, if maintained over a defined period of time, affords the same thermal challenge to a drug substance or drug product as would be experienced over a range of higher and lower temperatures.

National AIDS and STI Control Programme. A Kenyan program under the Ministry of Health that coordinates the national response to HIV/AIDS and sexually transmitted infections, including the management of related pharmaceuticals.

New Drug Application. A regulatory submission to the Pharmacy and Poisons Board (PPB) in Kenya for approval to market a new pharmaceutical product.

National Quality Control Laboratory. A Kenyan institution responsible for testing and ensuring the quality, safety, and efficacy of medicines and medical products before they are distributed in the market.

Out of Specification. A result that falls outside the predetermined acceptance criteria for a product or process, requiring investigation and corrective action.

Out of Trend. A result that does not follow the expected trend in a series of data points, indicating a potential issue in the manufacturing or testing process.

Periodic Benefit-Risk Evaluation Report. The ICH-harmonised format for periodic safety reporting that has largely replaced the traditional PSUR in many markets. It presents a critical, integrated evaluation of a medicine's benefit-risk profile using cumulative and interval safety data.

Post-Market Clinical Follow-up. The systematic collection of clinical data on a medical device after market launch to confirm continued safety and performance. Required for higher-risk devices.

Post-Market Surveillance. A system managed by the PPB in Kenya to monitor the safety and quality of medicines after they have been released to the market, including reporting adverse drug reactions.

The systematic monitoring of the safety, quality, and performance of a medicine or medical device after it has been placed on the market. It includes adverse-event and product-complaint handling, periodic safety reporting, and, where needed, field safety actions or recalls. In Kenya it is overseen by the Pharmacy and Poisons Board and is often abbreviated PMS.

Pharmacy and Poisons Board. The drug regulatory authority in Kenya.

Pharmaceutical Quality System. A management system to direct and control a pharmaceutical company with regard to quality, encompassing GMP and other quality-related activities.

An action taken to eliminate the cause of a potential nonconformity or other undesirable situation before it occurs. It is the proactive half of CAPA and is often driven by trend analysis, risk assessment, or lessons learned from other products or sites. Preventive actions reduce the likelihood of future deviations and quality failures.

Pharmacy Regulatory Information Management System. The Pharmacy and Poisons Board's online portal for medical-device, medicine, supplement and GMP applications in Kenya. Currently runs as PPB IMS v3.1.

Periodic Safety Update Report. A pharmacovigilance document, prepared by the marketing authorisation holder at defined intervals, that summarises the worldwide safety experience of a medicine and reassesses its benefit-risk balance. It is submitted to regulators to support the continued marketing authorisation of the product.

Pharmacovigilance. The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Pre-Export Verification of Conformity. KEBS's mandatory pre-shipment inspection scheme that ensures imported regulated products meet Kenyan standards. Inspectors are appointed agents (e.g. Intertek, Bureau Veritas, SGS).

Quality Management System. A structured system of procedures and processes covering all aspects of pharmaceutical production and quality control to ensure that products meet the required standards.

Qualified Person for Pharmacovigilance. A suitably qualified individual, appointed by a marketing authorisation holder, who is responsible for establishing and maintaining the pharmacovigilance system and acts as the single point of contact for the regulator on drug safety. The role supports adverse-event reporting, signal management, and periodic safety reporting obligations to authorities such as the Pharmacy and Poisons Board.

The status of starting materials, intermediate, bulk, or finished products set apart physically or by other effective means while awaiting a decision on their release or rejection.

Railway Development Levy. A 2% (current rate) Kenyan customs levy on the customs value of imports, applied alongside import duty and VAT.

A method of removing or correcting products that are in violation of laws administered by the regulatory authority.

The date after which a material, typically an active pharmaceutical ingredient or excipient, should be re-examined to confirm it still meets specification before further use. Unlike an expiry date, material that passes retesting may continue to be used for a further defined period. Retest periods are established from stability studies.

A structured investigation method used to identify the underlying reason a deviation, complaint, or failure occurred, rather than only treating its symptoms. Common tools include the five whys, fishbone (Ishikawa) diagrams, and fault-tree analysis. A sound root cause analysis underpins effective corrective and preventive action.

Saudi Food and Drug Authority. Saudi Arabia's national medicines and medical-device regulator. Accepted by PPB as a Reference Regulatory Authority.

The period during which a pharmaceutical product is expected to remain within its approved specifications when stored under the labelled conditions. It is established through stability studies and defines the product's expiry date. Storage outside the labelled conditions, including temperature excursions, can shorten the effective shelf life.

The process of reviewing pharmacovigilance data to identify new information about a possible causal association between a medicine and an adverse event, or a new aspect of a known association. Signals may arise from spontaneous reports, published literature, or safety databases, and are then validated, assessed, and, where confirmed, acted upon. It is a core activity of post-market drug safety monitoring.

Standard Operating Procedure. A set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations.

The Swiss Agency for Therapeutic Products. Switzerland's national medicines and medical-device regulator. Accepted by PPB as a Reference Regulatory Authority.

An event in which a stored or transported product is exposed to a temperature outside its labelled or approved storage range. Each excursion must be documented, investigated, and assessed for impact on product quality before the affected stock is released or rejected. Mean kinetic temperature calculations and product stability data are commonly used to decide whether the product remains fit for use.

Therapeutic Goods Administration. Australia's national medicines and medical-device regulator. Listed on PPB PRIMS as an acceptable Reference Regulatory Authority.

The single-window trade-facilitation platform Kenya uses for import / export documentation. Operated by KenTrade. KRA PIN, BL/AWB and invoice references are linked to each declaration.

United States Dollar. The international invoicing currency commonly used in Pharma Partner professional fees; KES equivalent quoted at the prevailing rate.

Verification and Validation. Verification confirms that a device or process meets its specifications; validation confirms that it meets the user's needs and intended use. Both are required dossier elements for moderate- to high-risk medical devices.

The documented act of demonstrating that a procedure, process, or activity will consistently lead to the expected results. It includes the qualification of systems and equipment.

Value Added Tax. Kenya's indirect tax on the sale of goods and services, charged on imports at customs valuation.