An operational due diligence across two African pharma manufacturers benchmarked true capacity vs future demand, validated capex plans, and identified strong potential for OEE, manpower and GMP improvements before investment decisions.
Context and Challenges
An investor was evaluating two established pharma plants (sterile injectables, tablets, capsules, syrups, ointments) as part of a potential acquisition and partnership.
Although both sites were GMP-compliant and run by experienced management teams, several questions were open:
- Are current lines sufficient to meet future volume projections under 2–3 shift scenarios, or is major capex required?
- How reliable are capacity, yield, logbook and KPI data, given heavy reliance on manual recording and some signs of “copied” readings (e.g., water treatment chlorine values)?
- What operational excellence levers (OEE, TPM, manpower productivity, layout, 5S) could unlock additional capacity and cost savings post-deal?
The investor needed a fact-based view of “as-is” performance, realistic upside and focused capex before taking an investment decision.
Our Approach
Assessment & Data AnalysisCollected detailed data on last year output, standard machine hours, working days and utilization for each key line (ampoules, vials, compression, coating, blistering, cartoning, sachets, capsules, syrups).
- Built future capacity models by adjusting working days, media-fill days and maintenance days—e.g., raising sterile workdays from 5 to 6.5 per week and reducing media-fill and maintenance days.
- Reviewed equipment age tables and utilities conditions to understand reliability and hidden capex needs.
Identification of Key Focus Areas
- Highlighted bottlenecks such as ampoule filling, blistering and mixers; under-utilised assets (many lines only in 1 shift); and low-value manual secondary packaging on high-volume SKUs.
- Flagged data-integrity and GMP risks—repeated logbook entries, mis-set tolerances and gaps in utilities maintenance (rusted flanges, missing bolts, damaged insulation).
Due Diligence Deep-Dives
- Ran OEE and TPM lens on key lines using sample OEE structures, downtime categorisation and TBM/CBM & Autonomous Maintenance examples (as illustrated in the OEE and maintenance sheets)
- Analysed secondary packaging product mix by line (automatic / semi-automatic / manual) to reallocate high-volume products to automatic lines and move low-volume SKUs off bottleneck assets.
Implementation & Value-Creation Roadmap
- Prepared plant-wise roadmaps covering capacity unlocks (e.g., shift additions, media-fill optimisation), focused capex, TPM/OEE roll-out and manpower productivity projects, with quantified impact and timing
Key Strategies Recommended
Capacity & Capex Rationalisation
- Showed that future tablet and capsule volumes can be handled within existing compression and coating capacity under higher shift utilisation, with selective debottlenecking rather than full new lines.
- Recommended ~USD 4M of “smart capex” for high-impact items—higher-speed ampoule filling, upgraded blister/cartoning, and larger wet-granulation / mixing capacity to reduce batch changeovers.
OEE & TPM Foundation
- Introduced standard OEE definitions (availability, performance, quality) and a sample OEE data collection sheet, with focus projects on breakdown, changeover, speed losses and quality rejects on tablets, blisters and ampoules.
- Proposed roll-out of Time-Based and Condition-Based Maintenance and Autonomous Maintenance checklists at operator level to stabilise basic conditions and cut chronic breakdowns.
GMP, SOP & Data Integrity Upgrades
- Strengthened shop-floor SOP adherence with better maker/checker roles, more realistic utility and quality specifications, and visual management of key quality parameters.
- Recommended digitising critical logs (production, maintenance, water system) to avoid repeated manual entries and enable analysis.
Layout, 5S and Manpower Productivity
- Suggested converting traditional batch-and-queue layouts into straighter flow lines with cellular workstations, improving 5S and point-of-use storage, especially in secondary packaging, utilities and warehouses.
- Proposed time-and-motion and line balancing for manual and semi-automatic packing, where photos showed overstaffed tables and multiple handling of packs.
Results and Investor Insights
Confidence on Growth Capacity: Demonstrated that, with increased workdays (5 → 6–6.5 per week), reduced media-fill and maintenance days (42 → 32 media-fill days; 14 → 10 maintenance days), and better utilisation, most future volume plans can be met on existing assets, except for targeted sterile expansions.
Clear Value-Creation Roadmap: Quantified OEE and manpower productivity improvement potential in high-volume lines, underpinning post-deal EBITDA and cash-flow uplift.
De-risked Capex and Compliance: Re-prioritised capex towards high-return debottlenecking, automation and utilities reliability, while flagging specific GMP/data-integrity remediation actions required pre- and post-investment.