Glossary of Terms used for Pharmaceutical Sourcing

Acceptance Criteria: The specifications and acceptance or rejection limits—such as acceptable quality level or unacceptable quality level with an associated sampling plan—that are necessary for making a decision to accept or reject a lot or batch of raw material, intermediate, packaging material, or excipient.

B2B: Business to Business. Transaction between two businesses.

B2C: Business to Consumer. Transaction between a business and a consumer.

Batch (Lot): A defined quantity of processed API or excipient which can be expected to be homogeneous. In a continuous process, a batch corresponds to a defined portion of the production based on time or quantity (e.g., vessel's volume, one day's production, etc.).

Broker: An entity that acts as an intermediary between a buyer and a seller of products or services. Brokers neither buy nor take possession of the products or services.

BOM (Bill of Material): A listing for each product or sub-assembly of all the components or sub-assemblies that go into it and how many are required.

Calibration: A process that typically focuses on instruments or devices to provide assurance that they produce results within specified limits. Organizations need to include the appropriate qualification, validation, and calibration activities in their SOPs and master schedules and should follow protocols to conduct these activities and final reports.

COA (Certificate of Analysis): A document that reports the results of a test of a representative sample drawn from the batch of material that will be delivered.

COC (Certificate of Conformance): A document that certifies that the supplied goods or service meets the required specifications. Also known as Certificate of Conformity and Certificate of Compliance.

COS/CEP (Certificate of Suitability to the European Pharmacopoeia): Certification granted to individual manufacturers by the European Directorate for the Quality of Medicines when a specific excipient or active ingredient is judged to be in conformity with a European Pharmacopoeia monograph.

Consignment: The quantity of medical products supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include pharmaceutical products belonging to more than one batch.

Contract Manufacturing: The CMO (Contract Manufacturing Organization) is contracted by a pharma company to provide the materials and labor to manufacture drug products which are then owned and paid for by the client.

Contract packager: A contract packager is an establishment that is contracted to package or repackage a drug product into a single- or multi-unit container. These containers should meet all of the applicable requirements in this chapter. A contract packager does not take ownership from the manufacturer and generally receives the assigned expiration date from the contractor.

Controlled Room Temperature (CRT): According to the U.S Pharmacopeia (USP) it is a maintained temperature between 20-25°C, excursions within the realms of 15-30 °C.

Drug Master File (DMF): Detailed information about the manufacture of an API & excipient that is submitted to the regulatory body.

Expiry (Expiration) Date: The date designating the time during which the API & excipient is expected to remain within specifications and after which it should not be used.

FIFO (First In First OUT): Inventory policy in which product is used in the order in which received.

Good distribution practices (GDP): That part of quality assurance that ensures that the quality of a medical product is maintained by means of adequate control of the numerous activities that occur during the trade and distribution process, as well as providing a tool to secure the distribution system from falsified, unapproved, illegally imported, stolen, substandard, adulterated and/ or misbranded medical products.

GMP Certificate: The minimum standard that a medicines manufacturer must meet in their production processes.

Good storage practices (GSP): That part of quality assurance that ensures that the quality of medical products is maintained by means of adequate control throughout the storage thereof.

Primary Container–Closure System: The packaging components that come into direct contact with the excipient in the closed, sealed package during storage and transport.

Protect from light: Where light subjects an article to loss of strength or potency or to destructive alteration of its characteristics, the Container label bears an appropriate instruction to protect the article from light. The article must be packaged in a light-resistant Container.

Qualification: Qualification is the assurance that systems or equipment meet predetermined acceptance criteria. This process typically focuses on equipment and utilities such as refrigerators and HVAC systems, as well as packaging. There are several different types of qualification, and an organization should determine which to use and when. Some of these include design qualification, installation qualification, operational qualification, and performance qualification.

Quarantine: The status of materials isolated physically or by other effective means pending a decision about their subsequent approval or rejection.

Raw Material: A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or excipients.

Retest date: The date when a material should be re-examined to ensure that it is still suitable for use.

Service level agreement (SLA): An SLA or contract is a negotiated agreement between the customer and service provider that defines the common understanding about materials or service quality specifications, responsibilities, guarantees, and communication mechanisms. It can either be a legally binding document or an information agreement. The SLA may also specify the target and minimum-level performance, operation, or other service attributes.

Significant Change: A change that alters an API, excipient's physical or chemical property from the norm or that is likely to alter the excipient's performance in the dosage form.

Specification: The quality parameters to which the API, excipient, component, or intermediate must conform and that serve as a basis for quality evaluation.

Supply chain management (SCM): The successful management of pharmaceutical supply chain operations to gain competitive advantages and customer satisfaction.

Temperature excursion: An event in which a pharmaceutical product is exposed to temperatures outside of the range(s) prescribed for storage and/or transport. Temperature ranges for storage and transport may be the same or different; they are determined by the product manufacturer, based on stability data.

Traceability: Ability to determine the history, application, or location that is under consideration, e.g., origin of materials and parts, processing history, or distribution of the product after delivery.

TSE/BSE Certificate: Transmissible spongiform encephalopathy (TSE) & Bovine spongiform encephalopathy (BSE) free certification.

Validation: Validation typically focuses on processes and procedures, to provide assurance that the processes or equipment produce the desired outcome.

Few Common abbreviation:

BOE = Bill of Entry/ exchange

BOM = Bill of Materials

COA = Certificate of Analysis

CS = Comparison Statement.

ERP = Enterprise resources Planning

FAT = Factory Acceptance Test

FIFO = First in First Out

FEFO = First Expired First  Out

GRN = Goods Received Note (GRN is a voucher made against receipt of finished goods)

GTIN: Global trade item number 

LC = Letter of credit

LIFO = Last in First Out

MIR = Materials Issue Requisition

MOA = Method of Analysis

MRIR = Material Receive and Inspection Report

MRN = Material receive note. (MRN for raw materials, spares parts, sub-assemblies, components etc.)

PO = Purchases Order

PR = Purchases Requisition

SPR = Store Purchases Requisition

SOP = Stander operating procedure

SR = Store Requisition

SAP = System Application Process 

SAT = Site Acceptance Test

QC = Quality Certificate

W/O=Work Order

Read also: Global Pharma Suppliers

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