Pharmaceutical Manufacturing Process Line Clearance

A computer-implemented process performed by a computer apparatus for generating a quality control, QC, record to document line clearance of a pharmaceutical production line for manufacturing another batch of pharmaceutical product by populating a line clearance protocol, the line clearance being performed by an operator wearing an augmented reality, AR, headset, the process comprising:

• providing a process data structure defining a sequence of operator actions;
• establishing a data communication connection between the AR headset and the computer apparatus;
• providing the computer apparatus with a line clearance protocol comprising a plurality of content items and associated fields, wherein the fields are to be populated as an operator progresses through the operator actions;
• providing the computer apparatus with a mapping data structure that links operator actions to line clearance protocol content items and associated fields;
• transmitting overlay image data to the connected AR headset, the overlay image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the line clearance protocol fields;
• receiving user interface commands from the connected AR headset;
• populating fields of the line clearance protocol, as presented to the operator in the overlay image data, responsive to receipt of the user interface commands;
• performing a QC check of the line clearance based on an automated analysis of what has been entered in the fields of the QC record, wherein the QC check compares the field entries with what is permitted in those field entries according to a specification that forms part of the line clearance protocol;
• output a QC check outcome selected from the following:
• the results indicate that the line clearance meets specification;
• the results indicate that the line clearance does not meet specification;
• and optionally also the results indicate that the line clearance may not meet specification;
• transmit the QC record and QC check outcome to a workstation for review by a supervisor;
• and
• receive a line clearance decision from the workstation and enter it in a corresponding field of the QC record.

A computer program product bearing machine-readable instructions for performing a computer-implemented process for generating a quality control, QC, record to document line clearance of a pharmaceutical production line for manufacturing another batch of pharmaceutical product by populating a line clearance protocol, the line clearance being performed by an operator wearing an augmented reality, AR, headset, the process comprising:

• providing a process data structure defining a sequence of operator actions;
• establishing a data communication connection between the AR headset and the computer apparatus;
• providing the computer apparatus with a line clearance protocol comprising a plurality of content items and associated fields, wherein the fields are to be populated as an operator progresses through the operator actions;
• providing the computer apparatus with a mapping data structure that links operator actions to line clearance protocol content items and associated fields;
• transmitting overlay image data to the connected AR headset, the overlay image data presenting ones of the content items and associated fields to the operator in a way that follows the operator's progression through the operator actions as determined with reference to the mapping data structure and that is responsive to the operator populating the line clearance protocol fields;
• receiving user interface commands from the connected AR headset;
• populating fields of the line clearance protocol, as presented to the operator in the overlay image data, responsive to receipt of the user interface commands;
• performing a QC check of the line clearance based on an automated analysis of what has been entered in the fields of the QC record, wherein the QC check compares the field entries with what is permitted in those field entries according to a specification that forms part of the line clearance protocol;
• output a QC check outcome selected from the following:
• the results indicate that the line clearance meets specification;
• the results indicate that the line clearance does not meet specification;
• and optionally also the results indicate that the line clearance may not meet specification;
• transmit the QC record and QC check outcome to a workstation for review by a supervisor;
• and
• receive a line clearance decision from the workstation and enter it in a corresponding field of the QC record.