Use Case #2 (UC-2) Terms and Definitions

Note 1 to entry: The definition provided here is very close to that given in ISO 10303-49. Nevertheless ISO 15531 needs the notion of structured set of activities, without any predefined reference to the time or steps. In addition, from the point of view of flow management, some empty processes may be needed for a synchronisation purpose although they are not actually doing anything (ghost task).
[SOURCE:ISO 15531-1]

Note from discussion that we need a definition of activity, which may be synonymous with process step in this context, so we should clarify. *** We could refine the definition to use the term 'step' as opposed to activity, but only if they are synonyms for our use cases.

Note 1 to entry: Manufacturing processes may be arranged in process layout, product layout, cellular layout or fixed position layout. Manufacturing processes may be planned to support make-to-stock, make-to-order, assemble-to-order, etc., based on strategic use and placements of inventories.
[SOURCE:ISO 15531-1]

Note 1 to entry: The critical process, critical process steps, starting and processing materials and critical production parameters are included.

Note that this is more specific than the definition of manufacturing process from ISO 18629, so perhaps we need to make the name more specific - there may be a distinction between manufacturing of packaging, devices, and pharmaceutical products needed, but perhaps we defer that until we have a use case that requires those distinctions.

each step in the manufacture, preparation, propagation, compounding, or processing of a drug or an animal feed bearing or containing a new animal drug 

Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients | FDA

From CFR - Code of Federal Regulations Title 21, Volume 4, 21CFR207.1
CFR - Code of Federal Regulations Title 21 (fda.gov)

Manufacture: All operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage, and distribution of APIs and related controls.

Manufacture includes the making by chemical, physical, biological, or other procedures or manipulations of a drug, or an animal feed bearing or containing a new animal drug, including control procedures applied to the final product or to any part of the process. Manufacture includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process, including, for example, analytical testing of drugs for another registered establishment's drug.

Notes from JG

Note that this is the definition of process stage rather than step, but is as close as I could find in the ISA standard

• Process step are each of the steps of the manufacture process.
  Adapted (JG Fontaine)
• How to identify each process steps: TBC - impact of continuous manufacturing? Keep in mind the isolation steps?

Guidance for Industry, Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients | FDA

From CFR - Code of Federal Regulations Title 21, Volume 4, 21CFR207.1
CFR - Code of Federal Regulations Title 21 (fda.gov)

See above - the definition JG provided for manufacturing process is a better definition for manufacturing process step

This allows us to accommodate packaging manufacturing, etc. which are not included in the more narrow definition.

A batch is also defined in this standard as:

• entity that represents the production of a material at any point in the process
•  entity that represents the execution of a control recipe

The definition of batch implies that there is a concept of manufacturing order and also manufacturing cycle. These may be lower priority for this cycle, but will be ultimately needed.

A batch has a relationship with a packaged medicinal product (1 - many) and has an expiration date. (See the diagram at the end of 11615). The batch expiry date also applies to the packaged medicinal product. A batch number may be unique locally, i.e. for identifying a batch for some product, but may not be globally unique. It could be globally unique if for example it includes the product line or some other indicators, though.

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product at the package level.

abbreviation: BAID1 / IBAID1, where the latter is for the investigational medicinal product

Note 1 to entry: It is constructed by using the batch number assigned by the manufacturer and the expiration date. This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of a medicinal product based at the level of the immediate container.

abbreviation: BAID2 / IBAID2, where the latter is for the investigational medicinal product

NOTE Some examples of common traits are material source, the master recipe used to produce the material, and distinct physical properties.

NOTE 2 As defined in ANSI/ISA-95 and IEC 62264-1 as material lot: uniquely identifiable amount of a material.

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.

abbreviation: IPCID

Note 1 to entry: This is for indexing purposes and to contribute to improving patient safety by allowing for the unique identification of medicinal products worldwide.

abbreviation: PCID

synonym: packaged medicinal product identifier

Johnson & Johnson

Examples include a structure or building, an archeological dig, the landing location for an aircraft or spacecraft, and the site of a wound. A given site may accommodate multiple facilities.

A physical site has certain characteristics that contribute to the context it provides, including area, shape, accessibility, and in the case of a geographic site, landforms, soil and ground conditions, climate, and so forth.

sellable article

(material)