A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Sampling

Sampling commonly describes the process of taking samples/units of finished material, In-process Material, Raw Material or Components for assessment.

Sampling Plan

A sampling plan describes the details of the planed sampling activity e.g. the number of units or quantity of Material that must be collected and the manner in which it is to be collected.

Sanitation

The term sanitisation in the GMP environment is defined as the hygienic control on production processes as well as personnel, premises, equipment and material handling. This will reduce e.g. the bio-burden to a defined level.

Scale-up

The term scale up is often used to describe the increase of a batch size during development of a Drug Substance or Drug Product.

Segregation

The tem segregation describes the physical separation of Product or equipment.

Self Inspection

The term Self Inspection is used for the scheduled internal Audits to check for compliance with cGMP, ISO requirements or other relevant requirements.

Self Inspection

The term Self Inspection is used for the scheduled internal Audits to check for compliance with cGMP, ISO requirements or other relevant requirements.

Semi Finished Product

The definition semi-finished product stands for product that has not completed the full production steps, such as tablets waiting blistering, or filled vials waiting labelling.

Shelf Life

The Shelf Life, which is used to establish the Expiry Date of each Batch is the timeframe at which a drug product is expected to stay within its predefined specification.

Shelf Life Specification

The predefined combination of physical, chemical, biological and microbiological test Requirements that a drug product must meet during its shelf life or a drug substance up to its retest.

Shipping

The term shipping is used in the GMP environment for the transport of any pharmaceutical product or ingredient in accordance with the GMP regulations.

Side effect

Secondary and usually adverse effect, as from a drug or other treatment. For example, nausea is a side effect of some anticancer drugs. 

Single-blind study

A study in which one party (either the patient or investigator) is unaware of what medication the patient is taking.

Site

A site is called any facility where GMP operations for Drug Product or Drug substance, a testing, a research or distribution are conducted.

Site Master File

A site master file is the comprehensive documentation describing the facilities, utilities, computer systems, organizational structure and manufacturing processes at a site.

Site Quality Manual

A Site Quality Manual is the documentation of the Quality Systems in place at a Site.

Site Training Plan

The site training plan documents the overall training program to be performed in a certain time period (annually) within the site.

Site Validation Master Plan

The site validation master plan describes the assessment of the validation for the sites facilities, utilities, computer systems and manufacturing processes.

Solvent

Any liquid used as a vehicle for the preparation of solutions or suspensions in the synthesis of an API or intermediate. 

Specification

Any predetermined requirement to which a Finished Product, Material, Process, Equipment, Service, or other activity must conform.

Specifications

The term specification is used for the predefined written, chemical, physical, biological and environmental characteristics for testing a product or system. This includes but is not limited to starting materials, packaging materials, intermediate, bulk, drug substance or drug product.

Stability

The term stability is used for the ability of a drug product or drug substance to stay in there chemical, physical, microbiological and biopharmaceutical specified limits during its whole shelf life.

Stability Program

The stability program is a planned and documented program assessing the stability profile of materials and products to establish their retest periods or shelf life and storage directions.

Stability Testing

Stability testing is the testing used to provide evidence on how the Quality of a API or Drug Product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light.

Standard Operating - Operation Procedure-SOP

A SOP is an authorized and approved written procedure giving instructions to perform standard operations.

Starting Material

A material used in the synthesis of an API, which is incorporated as an element into the structure of an intermediate and/or of the API. Starting materials are normally commercially available and of defined chemical and physical properties and structure. 

Statistical Control

Process for which the observed values are scattered about a mean value in such a way as to imply that the origin of the variations is entirely random with no assignable causes of variation and no runs or trends.

Statistical Process Control

Statistical Process Controls are statistically based techniques, e.g. for measuring and trending for the assessment and control including special cause variation in a system or process.

Status

The term status in the GMP environment is commonly used for an assessment of the condition of equipment, materials or processes.

Status Label

A status label is a designation, physically or electronically indicating the acceptability for use, further processing or distribution of any material, product, or equipment such as quarantined, approved, rejected, restricted use, etc.

Sterile Product

Products that have been processed to ensure that there is absence of living organisms.

Stock Recovery

The removal or correction of a product that has not been marketed or has not left the direct control of the site.

Strength

The concentration of the drug substance ( for example, weight/weight, weight/volume, or unit dose/volume basis) and/or, The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard). 

Study Arm

Patients in clinical trials are assigne to one part or segment of a study – a study "arm". One arm receives a different treatment from another.

Sub-Contractor

A supplier, vendor or consultant used by contractor of the company.

Subject Matter Expert-SME

A company employee who has demonstrated competency and mastery in a particular process or function. These individuals are called upon to answer question or provide detailed explanation of processes pertinent to their area of expertise during an inspection.

Supplier Audit

A Supplier Audit is a formal quality review of a supplier of goods or services for a company.

System Qualification

System Qualification (SQ) consists of the IQ/OQ documentation pertaining to all equipment, instruments, materials and subsystems within a specific system or unit operation, generally identified by a single Piping & Instrument Flow Diagram (P&ID).