Glossary of Terms
What is Annex 11?
Annex 11 is part of the European GMP Guidelines that defines the scope and limitations for computerised systems used by organizations in the pharmaceutical industry. Annex 11 defines the criteria under which electronic records and signatures are considered to be managed. It acts as a checklist for European regulatory agencies to establish the requirements for computerised systems for pharmaceutical products and medical devices.
What is an Annotation?
An Annotation is a note or comment that serves as extra information associated with a document or project.
What is Artwork?
Artwork is a printing matter which is placed on a product’s packaging material. It generally includes graphics, logos, barcodes, and product information. Packaging Artwork plays an essential role in communicating with the customer and contributes to the overall branding of a company.
See also: Branding
What is Aseptic Packaging?
Aseptic Packaging is a specialized packaging process in which food, pharmaceuticals, and other products are sterilized separately. The products are then inserted into the packaging container in a sterile environment. Aseptic Packaging prevents microorganisms from entering a package, producing shelf-stable products that do not need refrigeration.
See also: Medical Packaging
What is an Audit?
An Audit is a quality review process that evaluates a quality system with the intention of improving it. The purpose of an Audit is to provide management with information on how effectively the company controls the quality of its products and processes.
See also: Audit Trail
What is an Audit Trail?
An Audit Trail is a regulatory requirement in manufacturing that refers to a security-relevant chronological record that provides documents evidence of a sequence of activities that have affected an operation, procedure, or event.
See also: Audit
What is a Barcode?
A barcode is a method of representing data in a visual, machine-readable form. It consists of numbers and a pattern of parallel lines of varying widths that are printed on a product’s packaging for the purpose of identifying a product.
What is a Barcode Reader?
A Barcode Reader is an optical scanner that can read printed barcodes to decode the data contained in the barcode. The reader will then send the data to a computer where it can be logged.
What is Bar Width Reduction?
Bar width reduction or BWR is a method for adjusting the graphics design file of a barcode to compensate for press gain. Press gain or ink spread is one of the most common causes of poor barcode performance.
What is a Batch Number?
A Batch Number is a numerical code that is printed on the drug label that allows the history of its production to be traced. It allows manufacturers or suppliers to identify the batch in which the product was produced. If the product is not made in a batch, then the code should enable the date and place of manufacture to be identified.
What is Bleed?
Bleed is printing that goes beyond the edge of where the sheet will be trimmed. The bleed is the part on the side of a document that gives the printer a small amount of space to account for the movement of the paper and design inconsistencies. Artwork and background colors often extend into the bleed area.
What is Braille?
Braille is a writing system used by people who are visually impaired. Braille is written with characters that are represented by patterns of raised dots that are felt with the fingertips to form words.
What is Branding?
Branding is a market practice where a company creates a unique name, symbol, or design that distinguishes itself from other sellers. It is a way for companies to establish a unique image and position in the eyes of their consumers.
See also: Brand Integrity
What is Brand Equity?
Brand Equity is the value a company gains by having a well-known brand name. The value is usually determined by consumer experiences and perception of the brand. Brands with a high Brand Equity are believed to be superior in quality and reliability.
See also: Brand Integrity
What is Brand Integrity?
Brand Integrity is the way consumers perceive a brand through its products, services, images, and reputation. When a brand loses its integrity, its meaning and value to consumers are diminished.
See also: Brand Equity
What is a Calibration?
Calibration is a process that measures the accuracy of an instrument compared to a known standard. The standard is a device with known accuracy. If an instrument or device deviates from the known standard, the instrument must be adjusted to fit within specified limits.
What is a Carton?
A carton is a box or container commonly used in packaging. It is usually made of paperboard or corrugated board. Cartons are often used for food, pharmaceuticals, hardware, and many other types of products.
What is CFR Part 11?
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures.
What is Change Request?
A Change Request is a document that calls for the adjustment of a product or system. It often arises when a client or project manager wants an addition or alteration to the agreed-upon specifications of the project.
What is Compliance?
Compliance is a set of legal, technical, and corporate requirements that a brand or manufacturer must comply with in order to produce and market products.
See also: Compliance Check
What is a Compliance Check?
A Compliance Check is the review of a process, product, or project to determine if it complies with the requirements of a technical, legal, or corporate manufacturing regulation. Compliance Checks are commonly conducted to ensure product safety, health safety, and environmental impact.
What is Contract Packaging?
Contract Packaging is the complete process of assembling a product or good into its final finished packaging. It occurs when one company hires another company (the contract packager) to produce its packaging. A Contract Packaging company may have specialized equipment and expertise needed for a particular packaging operation.
What are the Current Good Manufacturing Practices?
The Current Good Manufacturing Practices (cGMP) are the Food and Drug Administration’s (FDA) formal regulations regarding the design, monitoring, control, and maintenance of manufacturing processes and facilities. CGMP is the main regulatory standard for ensuring pharmaceutical quality and ensures that the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.
What is a Declaration of Ingredients?
A Declaration of Ingredients is the label quantity, in percentage terms, of an ingredient or category of ingredients used in the manufacturing or preparation of a product. The ingredients are listed in order of predominance, with the ingredients used in the greatest amount first, followed in descending order by those in smaller amounts.
What is a Dieline?
A Dieline is a package template that ensures proper layout for a printed product. It is a diagram that shows all the cut lines and folds of a package in a flattened form. It is usually placed into the graphic's computer file as a separate layer for sizing and orientation purposes.
What is Die Cutting?
Die Cutting is the process of using a die to cut through materials such as paper and card on a die press to create a custom shape or size.
What is a Digimarc Barcode?
A Digimarc Barcode is an advanced barcode that can be applied to any print or packaging material. It links interactive content, like product information, when scanned with an enabled scanner or mobile device. It contains the same information as a UPC barcode but is generally undetectable by the human eye.
What is Digital Printing?
Digital Printing is the process of printing from a digital-based image directly to a variety of media. Digital printers are most commonly either inkjet or dry toner-based printers and are best used for items that require high amounts of detail, and orders of a smaller quantity.
What are Directions for Safe Use?
Directions for Safe Use describe how a product must be handled and used to avoid causing any harm to the consumer. These often include specific instructions on storing and disposing of the product and can usually be found on the packaging or insert of a product.
What is an FDA Recall?
An FDA Recall refers to a company or manufacturer’s removal or correction of a product that the FDA considers to be in violation of its laws. FDA Recalls can occur when the FDA deems a product to be defective or possibly harmful to consumers.
What is a Flatbed Scanner?
A Flatbed Scanner is an optical scanner with a flat, glass surface used to hold a sheet of paper for scanning. The scanner captures all elements of the document and does not require any movement of the document. Flatbed scanners are effective scanners for delicate materials such as vintage photographs, papers and other documents that are fragile.
What is Flexography?
Flexography is a form of printing that utilizes a flexible relief plate. It is often referred to as ‘surface printing’, ‘rotary printing’ or ‘modern letterpress printing’, and is commonly used for printing on packaging and other uneven surfaces. Flexography is often used with many different kinds of substrates to produce things such as printed paper, food and beverage labels, and other types of products.
What is Ghosting?
Ghosting is an offset printing defect characterized by the appearance of faint replicas of printed images in undesirable places. It can also refer to a faint reproduction of an image without actual ink transfer.
What are Glue Dots?
Glue Dots are double-sided, pressure-sensitive adhesive dots used in various applications. They are a clean and safe alternative to hot glue, liquid glue, and tapes. They are used to assemble packaging and lightweight materials.
What is Gravure Printing?
Gravure Printing is the process in which the image to be printed is etched into the printing plate, and the ink is transferred directly to the paper. This type of printing is primarily used for long runs of high-quality multicolor printing.
What is a GS1 Barcode?
GS1 is an organization that develops and maintains standards for barcodes. GS1 stands for Global Standards One and is used to encode information such as product numbers, serial numbers and batch numbers.
What is a Hickey?
A Hickey is a small spot or imperfection that appears in print on images or flat tints. These defects are usually caused by a particle or other source of debris attaching itself to the printing plate and come in two forms. Void hickeys are blank, unprinted spots in a printed area. Doughnut hickeys are solid printed areas surrounded by a circular unprinted area.
What is In-Line Quality Control?
In-Line quality control refers to inspections that are built into the production line. These inspection points inspect for the quality of the production procedure.
What is Inkjet Printing?
Inkjet Printing is a type of computer printing that recreates a digital image by propelling droplets of ink onto paper and plastic substrates. Inkjet printers are the most commonly used type of printer and range from small inexpensive consumer models to expensive professional machines.
What is Installation Qualification (IQ)?
Installation Qualification (IQ) is a documented process that verifies that a product has been properly installed. For this verification to occur, all aspects of a facility, utilities, and equipment that affect product quality must adhere to approved specifications.
What is ISO?
ISO stands for The International Organization for Standardization. It is an independent, non-governmental organization that facilitates world trade by providing common standards among nations. These standards range from manufacturing to technology, and aid in the creation of products that are safe, reliable, and good quality.
What is ISO 9001:2015?
ISO 9001:2015 is a company-level standard created by the International Organization for Standardization that specifies requirements for a quality management system of an organization. Organizations use the standard to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
What is ISO 9001?
The ISO 9000 family of quality management systems is a set of standards that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service.
What is Labeling?
Labeling is a part of branding that enables product identification. It is printed information that is bonded to the product for recognition and provides detailed information about the product. Customers can easily make decisions about a product after seeing the label.
What is Linear Barcode?
A Linear Barcode is a one-dimensional barcode made up of lines and spaces of various widths that create specific patterns to encode data. The UPC is the most common type of Linear Barcode and if often found on consumer goods.
What is Medical Packaging?
Medical Packaging is a sterile packaging that holds and protects medical or pharmaceutical products. Medical packaging must conform to the standards required to maintain the sterility of products until the point of use.
See also: Aseptic Packaging
What are Net Contents?
Net Contents are the amount of the consumable product of the trade item contained in a package, as declared on the label, which may include: net weight, volume, count, units, etc. It is calculated by subtracting the weight of any container or packaging from the total weight of the item.
What are Nutraceuticals?
Nutraceuticals are pharmaceutical alternatives that are used as dietary supplements and to treat and prevent diseases. Nutraceuticals provide some medical and physiological benefits but are not tested and regulated to the extent of pharmaceutical drugs. They are generally referred to as ‘health products’.
What are Nutritional Facts Label?
A Nutritional Facts Label is a label required on most packaged food in many countries, showing what nutrients are in the food. Labels are usually based on official nutritional rating systems.
What is Off-Line Quality Control?
Off-Line inspections are quality control processes that include removing a sample from the production line and inspecting it manually or with automation technology. With off-line inspection, printing components are removed from the line throughout the run.
What is Offset Printing?
Offset printing is a commonly used printing technique in which the inked image is transferred from a plate to a rubber blanket, then to the printing surface. When used in combination with the lithographic process, which is based on the repulsion of oil and water, the offset technique employs a flat image carrier.
What is Operational Qualification (OQ)?
Operational Qualification (OQ) is a process in the development of a product or equipment that verifies that the functionality of a product is as desired. It acts as a review of start-up, operational, maintenance, safety, and cleaning procedures where applicable. Each function is tested to ensure that it operates within stated limits.
What is Package Integrity?
Package Integrity is a package’s ability to preserve and protect its contents from physical, microbial, and chemical threats. Physical tests are often conducted to validate that packaging integrity has been maintained throughout the entire packaging process.l, which may include: net weight, volume, count, units, etc. It is calculated by subtracting the weight of any container or packaging from the total weight of the item.
What is Packaging Automation?
Packaging Automation is the process of packaging a product without human assistance. Packaging Automation can be as simple as automatically sealing cartons to a complete packaging line. Packaging Automation is used by many companies to improve efficiency and eliminate bottlenecks in the production process.
What is Pantone Color?
Pantone Colors are color codes that stand for a specific shade. The Pantone Color Matching System is largely a standardized color reproduction system. By standardizing the colors, different manufacturers in different locations can all refer to the Pantone system to make sure colors match without direct contact with one another.
What is Performance Qualification (PQ)?
Performance Qualification Performance Qualification (PQ) is the process of verifying that a product, system, or piece of equipment performs under simulated real-world conditions. The PQ is the final step in the qualification process is an essential part of maintaining ongoing production quality.
What is Pharmacode?
A Pharmacode is a barcode standard used in the pharmaceutical industry as a packaging control system. Also known as Pharmaceutical Binary Code, it can store numeric data from 3 to 131070. Pharmacodes are designed to be readable despite printing errors. They can be printed in multiple colors as a check to ensure that the remainder of the packaging is correctly printed.
What is Pre-flight?
In printing, Preflight is the process of confirming that the digital files required for the printing process are all present, valid, correctly formatted, and of the desired type. It is a standard procedure in the printing industry to prepare the files and ensure that they are ready for the correct printing.