Pharmaceutical manufacturing process control, support and analysis

A computer-implemented process for generating a batch record, BR, by populating a master batch record, MBR, as part of manufacture of a batch of pharmaceutical product by an operator wearing an augmented reality, AR, headset, the process comprising:

• providing a process data structure defining a sequence of manufacturing process steps required to be carried out to manufacture a batch, the batch manufacturing process steps involving respective operator actions, wherein the operator actions include performing at least one of a chromatographic and spectroscopic analysis of the batch using a chromatographic or a spectroscopic instrument;
• establishing a data communication connection between the AR headset and a computer apparatus to control the generation of the BR during manufacture;
• providing the computer apparatus with an MBR comprising a plurality of content items and associated fields, wherein the fields are to be populated as an operator progresses through the operator actions, the MBR including a group of fields relating to the analysis;
• providing the computer apparatus with a mapping data structure that provides links between ones of the operator actions to ones of the MBR content items and associated fields, including for the analysis;
• processing the received scene image data to extract a graph and associated graph metadata from the graph image, wherein the graph includes a plurality of peaks;
• interpreting the peaks of the graph with reference to the graph metadata to obtain peak data;
• populating the analysis fields with reference to the mapping data structure with the graph, the graph metadata and graph peak data;
• transmitting overlay image data to the connected AR headset to present to the operator the populated analysis fields;
• and
• receiving user interface commands from the connected AR headset to accept or reject the populated analysis fields.

A non-transitory computer readable medium storing instructions for performing a computer-implemented process for generating a batch record, BR, by populating a master batch record, MBR, as part of manufacture of a batch of pharmaceutical product by an operator wearing an augmented reality, AR, headset, the instructions comprising:

• one or more instructions which, when executed by one or more processors, cause the one or more processors to:
• provide a process data structure defining a sequence of manufacturing process steps required to be carried out to manufacture a batch, the batch manufacturing process steps involving respective operator actions, wherein the operator actions include performing at least one of a chromatographic and spectroscopic analysis of the batch using a chromatographic or a spectroscopic instrument;
• establish a data communication connection between the AR headset and a computer apparatus to control the generation of the BR during manufacture;
• provide the computer apparatus with an MBR comprising a plurality of content items and associated fields, wherein the fields are to be populated as an operator progresses through the operator actions, the MBR including a group of fields relating to the analysis;
• provide the computer apparatus with a mapping data structure that provides links between ones of the operator actions to ones of the MBR content items and associated fields, including for the analysis;
• process the received scene image data to extract a graph and associated graph metadata from the graph image, wherein the graph includes a plurality of peaks;
• interpret the peaks of the graph with reference to the graph metadata to obtain peak data;
• populate the analysis fields with reference to the mapping data structure with the graph, the graph metadata and graph peak data;
• transmit overlay image data to the connected AR headset to present to the operator the populated analysis fields;
• and
• receive user interface commands from the connected AR headset to accept or reject the populated analysis fields.