ERP for GMP manufacturing: materials, inventory, bills of materials and work orders

What the module does

• An item master and approved suppliers: materials (API, excipients, solvents, packaging components, labels, consumables) and products (intermediate, bulk, finished) with unit, shelf life and retest period, storage, hazard, QC on receipt against a LIMS specification, minimum stock, reorder quantity, lead time, standard cost, and up to 20 suppliers with their qualification documents; a GMP-critical item is ordered only from an approved supplier.
• Purchasing and QC on receipt: purchase orders sent to the supplier and received line by line; each receipt is a new lot in quarantine with its expiry from the shelf life, its LIMS sample registered against the item's specification, and an over-delivery accepted only on purpose.
• Inventory and genealogy: every lot with its origin, supplier lot, location, QC sample, decisions and movements; the quantity on hand computed from receipts, production, returns, issues, consumption, shipments, scrap and adjustments; the state read from the status and the dates (awaiting QC, quarantine, released, on hold, rejected, expired, retest due, consumed); and the parents of every in-process and finished lot, so a finished lot traces to every material lot it consumed.
• QA's signed release: a lot is released, rejected or held with the signer's credentials; the release waits for the LIMS sample's approval unless QA overrides with a reason that is recorded; a rejected lot is never released again; a released lot is mirrored to the MES, so dispensing on a batch record accepts only ERP-released, unexpired lots.
• Bills of materials as unit operations: templates by product category (oral solid dose, sterile injectable, lyophilized, biologic drug substance, cell or gene therapy, medical device and more) and product BOMs that start from them; stages in order (dispensing, granulation, blending, compounding, filtration, filling, lyophilization, inspection, packaging, labelling) with their lines, output, yield limits, setup, run and hold times, the resources they book and the QC tests they trigger; costing with labour, machine and QC rates and the site's overhead pools; an AI draft from the existing bill of materials, master formula or batch record that never invents a quantity; an AI review before QA approves; versions that supersede on approval.
• Work orders from dispensing to finished goods: requirements computed from the approved BOM for the quantity, scrap included; materials issued from released lots only; stages started and completed in order, each producing its in-process lot with the consumed lots as parents; the yield checked against the BOM's limits and, when outside, blocked until a deviation is linked or QA accepts it with a signed reason; the finished lot in quarantine for QA's release; reconciliation and closure.
• Scheduling and resources: the plan stage by stage from the planned start with setup, run and hold times, each QC test planned and due after the laboratory's turnaround, the release-ready date, resource bookings, conflicts between work orders on the same line, room or equipment, and the load per week against each resource's capacity.
• Budgeting with AI overhead: direct material, labour, machine and QC costs computed by the system from standard costs and rates, every line with its basis; overhead allocated by the AI from the BOM's pools (rate = annual amount ÷ annual basis volume, amount = rate × the order's basis), the arithmetic shown and the assumptions listed; whatever cannot be priced listed, never guessed.
• Sales and shipments: sales orders by customer with their lines, shipped only from released, unexpired finished lots, each shipment a movement on the lot with carrier and tracking.
• Planning: per item, the released, quarantined and on-hold stock, what open work orders reserve and still need, what is on order, the projected position against the minimum stock and the shortage to buy or make; the AI writes the priorities and the risks, and a person creates the orders.
• Seven alert rules with thresholds the organization sets: lots expiring or expired, lots waiting in quarantine, released stock below the minimum, work orders short of materials, yields outside limits, resources booked twice, purchase orders past their expected date.

How it fits the platform

The ERP and the MES are one record graph. A work order opens the batch record on the product's master batch record in force, the batch accepts only the lots the ERP has released, and the executed material entries are read back as consumption on the lots. Every QC sample the ERP needs, on receipt, in process or at release, is registered in the LIMS against the approved specification and followed on the lot or the work order; the release waits for the LIMS approval. A yield outside its limits or a rejected lot is investigated as a deviation in the quality system, and a new version of a bill of materials carries its change control. A resource is a CMMS asset, so its maintenance and qualification state sits beside its bookings.

Q Intelligence lists and reads items, bills of materials, lots, work orders and orders alongside every other record, and the same three tools the MCP server exposes (inventory status, material requirements, work order status) are available to connected systems through the REST API.

Where people decide

The system computes quantities, requirements, schedules, yields and direct costs and refuses what the rules forbid; the AI drafts, reviews, allocates and explains; people decide. QA releases every lot and accepts every yield outside its limits with an electronic signature, QA approves every bill of materials and its versions, and the planner creates every purchase order and work order the plan calls for. No quantity on hand is ever typed, and no release, acceptance or approval happens without a named person, a reason and a signature.