Uplifting API Supply Resilience: A Practical Strategy for Buyers — Checklist

Uplifting API Supply Resilience: A Practical Strategy for Buyers

API supply resilience is often discussed like an engineering problem—redundancy, inventory, alternate routes. Buyers know the operational reality is simpler and harder: resilience lives in the day‑to‑day behaviors you can actually enforce—performance visibility, disciplined change management, and rehearsed response.

Three external signals reinforce why this matters:

• ICH Q10 makes clear that a pharmaceutical quality system extends to the control and review of outsourced activities and purchased materials, with the company ultimately responsible for ensuring appropriate oversight. ICH Database+1

• ICH Q9(R1) explicitly flags that quality risk management should address product availability risks that can arise from manufacturing quality issues and reduce subjectivity in risk outputs. U.S. Food and Drug Administration+1

• Both FDA and EMA have continued to emphasize proactive shortage prevention through structured planning (risk management plans / shortage prevention plans). U.S. Food and Drug Administration+2European Medicines Agency (EMA)+2

What follows is a practical six‑step strategy you can run with your existing supplier governance—without launching a multi‑year “transformation” program.

1) Define a short KPI set and review cadence for suppliers

Most supplier scorecards fail for one of two reasons:

1. too many metrics (no one reads them), or

2. too few metrics (they miss the real risks).

A short KPI set should answer two questions:

• Are we likely to get material on time?

• Is that material likely to be acceptable without disruption?

Because purchased materials and outsourced activities remain within your quality system’s scope, it’s reasonable to structure the KPI set so it supports both Quality and Supply decisions. ICH Database+1

A “short but complete” KPI set (8 metrics)

Use this as a starting point—then trim to 6–8 total.

Supply performance

1. OTIF (On‑Time In‑Full) – % lots delivered by confirmed date and quantity

2. Confirmed lead time stability – variance vs quoted lead time

3. Allocation / backorder frequency – # of events per quarter

Quality performance
4) Lot acceptance rate – % lots accepted without deviation/investigation
5) Right‑first‑time documentation – CoA / shipment doc errors per lot
6) CAPA responsiveness – time to containment + time to closure (for supplier-caused issues)

Change management
7) Change notification timeliness – % changes notified per agreement timeline
8) Change success rate – % supplier changes implemented without causing receiving holds, deviations, or spec shifts

Review cadence (risk-based, not one-size-fits-all)

A practical cadence many buyers can sustain:

• Critical / single-source APIs: Monthly KPI review + quarterly business review (QBR)

• High-impact but not single-source: Quarterly KPI review + semi-annual QBR

• Lower criticality: Semi-annual KPI review

Operational tip: Make the cadence explicit in the supplier governance plan. If you “review ad hoc,” you’ll only review during failures—too late to be preventive.

2) Identify one candidate for dual sourcing and outline the plan

Dual sourcing is one of the highest-leverage resilience moves buyers can initiate, but it also fails frequently because “adding a second source” is treated as a purchasing action rather than a technical + quality + regulatory program.

A disciplined approach starts with a single candidate—not a portfolio-wide mandate.

Choosing a candidate (quick screen)

Pick one API (or key intermediate) that meets most of these:

• single-source and no qualified alternate

• long lead time / constrained capacity

• high patient / business impact if disrupted

• recurring quality or delivery volatility

• meaningful geopolitical / site concentration exposure

This aligns with the broader intent of shortage prevention frameworks: identify likely hazards and prioritize mitigations before disruption occurs. U.S. Food and Drug Administration+1

Outline a dual-source plan buyers can actually run

A buyer-led plan works best when it is structured into six workstreams with named owners:

1. Commercial (Buyer)

• NDA/MSA updates, pricing, allocation language, transparency requirements

2. Quality (QA Supplier Quality)

• supplier qualification, audit plan, quality agreement, deviation/CAPA interfaces
  (This sits squarely within Q10 expectations for managing purchased materials/outsourced activities.) ICH Database+1

3. Technical (CMC / MSAT)

• manufacturing route equivalence concerns, impurity profile expectations, analytical comparability strategy

4. Analytical (QC / Analytical Sciences)

• method transfer/verification, bridging studies, reference standards strategy

5. Regulatory (Reg Affairs / CMC Regulatory)

• filing impact assessment, timelines, and change management strategy
  (ICH Q12 provides a lifecycle framework intended to support predictable, efficient post-approval CMC changes and improve supply.) ICH Database+1

6. Supply Planning (Supply Chain)

• safety stock targets during tech transfer, launch sequencing, cutover plan

The key buyer insight: Dual sourcing is not “approve a new vendor.” It is “qualify a new supply chain capability.”

3) Schedule one tabletop exercise and assign owners to the outcomes

If you only discover your response gaps during an actual shortage, you’ve already lost time and optionality. A tabletop exercise is a low-cost way to pressure-test your playbook.

This concept aligns cleanly with business continuity management thinking (ISO 22301 is specifically focused on organizational resilience and continuity). ISO
It also fits with regulatory expectations for proactive planning to mitigate shortage risk. U.S. Food and Drug Administration+1

One tabletop scenario (choose one)

Pick one “high-likelihood, high-impact” scenario:

• Scenario A: Quality disruption
  A critical impurity trend triggers a receiving hold; investigation takes 30 days.

• Scenario B: Capacity disruption
  Supplier allocates volume due to upstream raw material shortage.

• Scenario C: Logistics disruption
  Export restrictions / lane closure delay shipments beyond expiry of an in-transit window.

What makes the tabletop valuable (and not theater)

The tabletop is successful only if it produces:

• a short list of decisions

• a short list of owners

• due dates and follow-through

Tabletop outcomes to force explicitly

• What is the decision authority for allocation?

• What are the inventory triggers (when do we enact conservation / substitution / alternate lot release strategies)?

• What information must the supplier provide within 24–48 hours?

• What are the escalation paths (supplier exec, internal quality leadership, regulatory notifications if relevant)?

EMA’s published guidance for companies on shortages and shortage prevention planning underscores structured approaches to prevent/mitigate shortages, which is exactly what tabletop exercises operationalize. European Medicines Agency (EMA)+1

4) Record decisions, owners, and due dates

Resilience is governance. Without a decision log, actions become informal and drift.

This is also where Q9(R1)’s intent matters in practice: risk tools should produce actionable, less subjective outputs—decisions with traceability, not just risk scores. U.S. Food and Drug Administration+1

Minimum governance artifacts:

• supplier KPI dashboard + review minutes

• dual-source candidate selection rationale

• tabletop exercise outputs and action plan

• an explicit escalation and communication tree

5) File supporting documents with the final record

If you cannot reconstruct the “why” behind a resilience decision, you will relitigate it during every disruption, audit, or leadership turnover.

A practical “final record” (for each major initiative) typically includes:

• KPI definitions + data sources + cadence

• QBR minutes and agreed corrective actions

• supplier risk screen and segmentation rationale

• dual-source plan with milestones and approvals

• quality agreement and change notification expectations

• tabletop agenda, participant list, scenario, decisions, and action owners

FDA’s shortage prevention guidance frames risk management plans as a way to proactively identify, prioritize, and implement mitigation strategies against hazards that could cause supply disruption. Keeping a coherent record set is how you demonstrate that proactive intent in a durable way. U.S. Food and Drug Administration+1

6) Schedule a follow‑up review to capture lessons learned

A resilience initiative is not complete at “plan approved.” You need a scheduled review that asks:

• Did the KPIs predict performance issues early enough?

• Did supplier behavior change after QBR actions?

• Did the tabletop identify gaps we actually closed?

• Did we reduce single-point-of-failure exposure?

This is a straightforward way to prevent resilience from becoming a one-time project.

Inline tools you can use immediately (copy/paste)

A) Supplier KPI Scorecard (short format)

Supplier:
Material(s):
Criticality tier:
Review cadence: Monthly / Quarterly / Semi-annual

Escalation rule (example): Any 2 KPIs below target for 2 consecutive cycles triggers QBR corrective action plan.

B) Dual-Sourcing Candidate One‑Pager

Candidate API / intermediate:
Current supplier/site:
Rationale (3 bullets):
1)
2)
3)

Risks to manage (tick all that apply):

• ☐ Impurity profile comparability

• ☐ Physical form (polymorph/PSD) comparability

• ☐ Analytical method transfer complexity

• ☐ Regulatory filing impact

• ☐ Lead time / capacity risk

• ☐ IP / route constraints

• ☐ Quality maturity gaps at alternate supplier

Workstreams + owners

• Commercial (Buyer):

• Quality (SQA):

• Technical (CMC/MSAT):

• Analytical (QC):

• Regulatory (RA):

• Supply Planning:

Milestones

• Identify alternate supplier by:

• Quality assessment/audit complete by:

• Technical evaluation complete by:

• First qualification lot by:

• Go-live readiness decision by:

C) Tabletop Exercise Agenda (60–90 minutes)

Scenario: (Quality disruption / Capacity disruption / Logistics disruption)
Scope: API X, site Y, lane Z
Participants: Buyer, SQA, QC, MSAT/CMC, Supply Planning, Regulatory (if needed)

1. Scenario briefing (5 min)

2. Current-state map: inventory, lead times, open POs (10 min)

3. Decision points walk-through (25 min)

   • allocation rules

   • release/disposition rules

   • customer/patient impact triggers

   • regulatory notification triggers (if applicable)

4. Gap identification (15 min)

5. Actions, owners, due dates (15 min)

6. Closeout: what will be filed and where (5 min)

D) Decision Log (minimum viable)

E) Lessons Learned Review (30 minutes)

When: 60–90 days after rollout (or after any disruption event)

• What did KPIs predict correctly/incorrectly?

• What supplier behaviors improved (or didn’t)?

• What tabletop gaps were closed vs still open?

• Which mitigation actions reduced lead time or failure probability?

• What should be standardized across suppliers?

Action list with owners/dates.

Checklist

• Define a short KPI set and review cadence for suppliers.
• Identify one candidate for dual sourcing and outline the plan.
• Schedule one tabletop exercise and assign owners to the outcomes.
• Record decisions, owners, and due dates.
• File supporting documents with the final record.
• Schedule a follow‑up review to capture lessons learned.

Notes:

This checklist is for educational use only and does not replace your internal procedures.