Lean in the pharmaceutical industry
Modules implemented by Lean specialists from the pharmaceutical industry, adapted to the GMP constraints of each workshop.
Our tools
Production
Gain capacity in an existing workshop before investing, without touching the validated state of your processes.
Cycle time: mapping of the batch flow, from dispensing to release, to measure the actual time of each step, waiting times and bottlenecks, and then reduce them.
Batch size increase: technical and regulatory feasibility study, impact on equipment, validation and the marketing authorisation dossier, implementation plan and change control.
S&OP and planning: set-up of a sales and operations planning process, scheduling of campaigns and product changeovers, alignment of production with demand and with quality control release capacity.
Quality control
In the QC laboratory, analysis lead time directly drives batch release lead time.
We map the path of samples, from receipt to certificate of analysis, to highlight waiting times, rework and non-value-adding steps. We then work on load levelling, grouping analyses into series, 5S organisation of workstations and method standardisation, and we set up lead-time indicators monitored routinely.
Packaging
On a packaging line, availability often depends on format changeovers and minor stoppages.
Format changeovers: application of the SMED method: separating operations to be done with the line stopped and with the line running, standardising settings and change parts, upstream preparation, controlled line clearance.
Line performance: measuring and improving OEE, analysis of minor stoppages and rejects, organisation of the workstation and supplies, training of line operators.
Maintenance
TPM (Total Productive Maintenance) adapted to a pharmaceutical workshop: first-level maintenance entrusted to production teams, within the limits imposed by cleanrooms, measuring and improving OEE, reducing stoppages and minor stoppages, standardising settings.
For your investments and equipment renewals, we calculate the total cost of ownership (TCO): acquisition, qualification, maintenance, parts and consumables, energy, and the cost of production downtime.
Technical expertise (maintenance plan, validated state, CMMS): Engineering page →Pharmaceutical documentation
Overly heavy documentation slows production, multiplies recording errors and lengthens batch record review.
We simplify your procedures and batch records without losing compliance: removal of duplicates and records without value, a clear document hierarchy, visual work instructions at the workstation, shorter review and release lead times. The same work prepares the move to electronic batch records.