Plain-language definitions of the regulations, standards and quality terms behind pharma, medical device and FMCG/CPG labeling, with links to the guides that go deeper.
21 CFR Part 11 is the FDA regulation that sets the criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records and handwritten signatures.
ALCOA+ is a set of principles for data integrity: data should be attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
An anti-tampering device is a feature on medicine packaging that shows whether the pack has been opened or interfered with since it left the manufacturer.
An audit trail is a secure, time-stamped record of who did what to a record or system, and when, including what changed. In regulated environments it is the evidence that a review or approval actually happened.
Change control is the documented process for proposing, assessing, approving, implementing and recording a change, so that nothing affecting product quality or compliance is altered informally.
Computer Software Assurance is FDA's risk-based approach to assuring that production and quality system software is fit for its intended use, focusing effort where a failure could affect product quality or patient safety.
A Data Matrix is a two-dimensional barcode that stores data in a square grid of dark and light modules. It is widely used in pharma serialization and medical device identification because it holds a lot of data in a small space.
The Drug Facts label is the standardized format FDA requires on over-the-counter (OTC) drug products in the US, with a fixed order of headings, set wording and minimum type sizes.
The Drug Supply Chain Security Act (DSCSA) is the US law that requires prescription drug packages to carry a product identifier, so that products can be traced and verified through the supply chain.
eIFU is the electronic version of a medical device's Instructions for Use, provided on a website or other electronic means instead of, or in addition to, a printed copy.
EUDAMED is the European Commission's database for medical devices and IVDs. It is where economic operators, devices and UDIs, certificates and market surveillance information are registered under the MDR and IVDR.
Annex 11 is the part of the EU GMP guidelines that covers computerized systems used in GMP-regulated activities for medicines, including validation, risk management, supplier oversight, audit trails and periodic review.
GS1-128 is a linear barcode standard used mainly on cases and pallets. It encodes data such as the GTIN, batch or lot, and dates, each labeled with a GS1 Application Identifier.
A GTIN (Global Trade Item Number) is the GS1 identification number used to identify a product at every level it's sold or shipped, from a single unit to a case. It's the number encoded in retail barcodes and many 2D codes.
GxP is the umbrella term for the "good practice" quality guidelines and regulations that apply to regulated life sciences activities, such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
An INCI name is the standardized name used to list a cosmetic ingredient on a product label, based on the International Nomenclature of Cosmetic Ingredients.
IQ, OQ and PQ are the three stages used to show that a system is fit for its intended use: installation qualification (installed correctly), operational qualification (works as intended across its operating range) and performance qualification (performs consistently in real use).
ISO/IEC 15416 and ISO/IEC 15415 are the international standards for grading the print quality of linear barcodes (15416) and two-dimensional symbols such as Data Matrix (15415).
MLR review is the process pharma and medical device companies use to approve promotional and scientific content before it's used, with Medical, Legal, and Regulatory reviewers each checking the material.
Rasterized text is text that has been converted into an image, so it looks the same on screen but is no longer stored as characters that software can read, search or compare.
The SmPC is the document that sets out the approved information on a medicine in the EU, including its composition, indications, dosage, contraindications and warnings. It is the basis for the package leaflet and for promotional claims.
The UDI-DI is the device identifier part of a Unique Device Identifier, specific to a device model and packaging configuration. The Basic UDI-DI, used in the EU, groups devices of the same model for registration and certificates.
21 CFR Part 11 is the FDA regulation that sets the criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records and handwritten signatures.
ALCOA+ is a set of principles for data integrity: data should be attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available.
An audit trail is a secure, time-stamped record of who did what to a record or system, and when, including what changed. In regulated environments it is the evidence that a review or approval actually happened.
Change control is the documented process for proposing, assessing, approving, implementing and recording a change, so that nothing affecting product quality or compliance is altered informally.
Computer Software Assurance is FDA's risk-based approach to assuring that production and quality system software is fit for its intended use, focusing effort where a failure could affect product quality or patient safety.
Annex 11 is the part of the EU GMP guidelines that covers computerized systems used in GMP-regulated activities for medicines, including validation, risk management, supplier oversight, audit trails and periodic review.
GxP is the umbrella term for the "good practice" quality guidelines and regulations that apply to regulated life sciences activities, such as Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
IQ, OQ and PQ are the three stages used to show that a system is fit for its intended use: installation qualification (installed correctly), operational qualification (works as intended across its operating range) and performance qualification (performs consistently in real use).
A Data Matrix is a two-dimensional barcode that stores data in a square grid of dark and light modules. It is widely used in pharma serialization and medical device identification because it holds a lot of data in a small space.
The Drug Supply Chain Security Act (DSCSA) is the US law that requires prescription drug packages to carry a product identifier, so that products can be traced and verified through the supply chain.
GS1-128 is a linear barcode standard used mainly on cases and pallets. It encodes data such as the GTIN, batch or lot, and dates, each labeled with a GS1 Application Identifier.
A GTIN (Global Trade Item Number) is the GS1 identification number used to identify a product at every level it's sold or shipped, from a single unit to a case. It's the number encoded in retail barcodes and many 2D codes.
ISO/IEC 15416 and ISO/IEC 15415 are the international standards for grading the print quality of linear barcodes (15416) and two-dimensional symbols such as Data Matrix (15415).
The UDI-DI is the device identifier part of a Unique Device Identifier, specific to a device model and packaging configuration. The Basic UDI-DI, used in the EU, groups devices of the same model for registration and certificates.
An anti-tampering device is a feature on medicine packaging that shows whether the pack has been opened or interfered with since it left the manufacturer.
The Drug Facts label is the standardized format FDA requires on over-the-counter (OTC) drug products in the US, with a fixed order of headings, set wording and minimum type sizes.
eIFU is the electronic version of a medical device's Instructions for Use, provided on a website or other electronic means instead of, or in addition to, a printed copy.
EUDAMED is the European Commission's database for medical devices and IVDs. It is where economic operators, devices and UDIs, certificates and market surveillance information are registered under the MDR and IVDR.
An INCI name is the standardized name used to list a cosmetic ingredient on a product label, based on the International Nomenclature of Cosmetic Ingredients.
Rasterized text is text that has been converted into an image, so it looks the same on screen but is no longer stored as characters that software can read, search or compare.
The SmPC is the document that sets out the approved information on a medicine in the EU, including its composition, indications, dosage, contraindications and warnings. It is the basis for the package leaflet and for promotional claims.
MLR review is the process pharma and medical device companies use to approve promotional and scientific content before it's used, with Medical, Legal, and Regulatory reviewers each checking the material.
