RM

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Assumptions

In production these values come from SAP and LIMS as named in each Source column. Values marked Assumption are illustrative.

ProductsAssumption

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3,00,000 tabletsImportedNo34 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
5,00,000 tabletsImportedNo34 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
5,00,000 tabletsImportedNo34 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
3,00,000 tabletsDomesticYes21 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
3,00,000 tabletsDomesticYes21 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
3,00,000 capsulesDomesticYes30 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
30,000 bottlesDomesticYes21 d2 / 4 dSAP MM material master · lead / QA times: Planner estimate (Assumption)
40,000 bottlesDomesticYes28 d3 / 5 dSAP MM material master · lead / QA times: Planner estimate (Assumption)

Equipment and GMP segregationAssumption

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General oral solidsDispensing boothNon-beta-lactam products2045%SAP PM equipment · MTS share: Planner estimate (Assumption)
Rapid mixer granulator 1Non-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
Rapid mixer granulator 2Non-beta-lactam products2045%SAP PM equipment · MTS share: Planner estimate (Assumption)
Fluid bed dryerNon-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
Compression machine 1Non-beta-lactam products2035%SAP PM equipment · MTS share: Planner estimate (Assumption)
Compression machine 2Non-beta-lactam products2035%SAP PM equipment · MTS share: Planner estimate (Assumption)
COAT-1Coating panNon-beta-lactam products2046%SAP PM equipment · MTS share: Planner estimate (Assumption)
Blister packing line 1Non-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
Blister packing line 2Non-beta-lactam products2045%SAP PM equipment · MTS share: Planner estimate (Assumption)
Penicillin blockDedicated penicillin dispensing2050%SAP PM equipment · MTS share: Planner estimate (Assumption)
Penicillin blender2055%SAP PM equipment · MTS share: Planner estimate (Assumption)
Capsule filler2055%SAP PM equipment · MTS share: Planner estimate (Assumption)
Penicillin blister packer2050%SAP PM equipment · MTS share: Planner estimate (Assumption)
Secondary packingCartoning line 1Sealed product only2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
Cartoning line 2Sealed product only2045%SAP PM equipment · MTS share: Planner estimate (Assumption)
Oral liquidsLiquid dispensingNon-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
MV-1Manufacturing vesselNon-beta-lactam products2055%SAP PM equipment · MTS share: Planner estimate (Assumption)
LF-1Liquid filling & capping lineNon-beta-lactam products2088%SAP PM equipment · MTS share: Planner estimate (Assumption)
LBL-1Bottle labellingNon-beta-lactam products2050%SAP PM equipment · MTS share: Planner estimate (Assumption)
LC-1Bottle cartoningNon-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
Sterile ophthalmicOphthalmic dispensingNon-beta-lactam products2045%SAP PM equipment · MTS share: Planner estimate (Assumption)
OC-1Ophthalmic compoundingNon-beta-lactam products2050%SAP PM equipment · MTS share: Planner estimate (Assumption)
SF-1Sterile filtrationNon-beta-lactam products2050%SAP PM equipment · MTS share: Planner estimate (Assumption)
OF-1Aseptic eye-drop fillingNon-beta-lactam products2058%SAP PM equipment · MTS share: Planner estimate (Assumption)
OV-1Eye-drop visual inspectionNon-beta-lactam products2048%SAP PM equipment · MTS share: Planner estimate (Assumption)
OP-1Eye-drop packingNon-beta-lactam products2050%SAP PM equipment · MTS share: Planner estimate (Assumption)

Penicillin equipment is dedicated. Each product remains at its registered manufacturing site. Planned downtime: LF-1 30 Oct 2026 – 1 Nov 2026 (Capper preventive maintenance); OF-1 21 Nov 2026 – 23 Nov 2026 (Aseptic line requalification).

Routings (hours per batch)Assumption

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Dispensing (3h) → Granulation / (8h) → Fluid bed drying (6h) → Compression / (14h) → Coating COAT-1 (12h) → Blister packing / (14h, needs PM) → Cartoning / (6h, needs PM)63hSAP PP-PI master recipe (Assumption)
Dispensing (3h) → Granulation / (8h) → Fluid bed drying (6h) → Compression / (14h) → Coating COAT-1 (12h) → Blister packing / (14h, needs PM) → Cartoning / (6h, needs PM)63hSAP PP-PI master recipe (Assumption)
Dispensing (3h) → Granulation / (8h) → Fluid bed drying (6h) → Compression / (14h) → Blister packing / (14h, needs PM) → Cartoning / (6h, needs PM)51hSAP PP-PI master recipe (Assumption)
Dispensing (3h) → Granulation / (8h) → Fluid bed drying (6h) → Compression / (14h) → Coating COAT-1 (12h) → Blister packing / (14h, needs PM) → Cartoning / (6h, needs PM)63hSAP PP-PI master recipe (Assumption)
Dispensing (3h) → Granulation / (8h) → Fluid bed drying (6h) → Compression / (14h) → Coating COAT-1 (12h) → Blister packing / (14h, needs PM) → Cartoning / (6h, needs PM)63hSAP PP-PI master recipe (Assumption)
Dispensing (4h) → Blending (6h) → Capsule filling (20h) → Blister packing (16h, needs PM) → Cartoning / (6h, needs PM)52hSAP PP-PI master recipe (Assumption)
Dispensing DB-L1 (3h) → Manufacturing MV-1 (8h) → Liquid filling & capping LF-1 (12h) → Labelling LBL-1 (6h, needs PM) → Cartoning LC-1 (4h, needs PM)33hSAP PP-PI master recipe (Assumption)
Dispensing DB-O1 (3h) → Compounding OC-1 (8h) → Sterile filtration SF-1 (4h) → Aseptic filling OF-1 (12h) → Visual inspection OV-1 (8h) → Packing OP-1 (6h, needs PM)41hSAP PP-PI master recipe (Assumption)

The first listed equipment is the default; "Use alternate equipment" lets a new order use the others too. Steps marked "needs PM" cannot start before packaging material arrives.

Changeover / cleaningAssumption

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6hValidated cleaning & line clearanceSAP PP-PI recipe · cleaning validation
6hValidated cleaning & line clearanceSAP PP-PI recipe · cleaning validation
6hValidated cleaning & line clearanceSAP PP-PI recipe · cleaning validation
6hValidated cleaning & line clearanceSAP PP-PI recipe · cleaning validation
6hValidated cleaning & line clearanceSAP PP-PI recipe · cleaning validation
8hDedicated beta-lactam cleaningSAP PP-PI recipe · cleaning validation
4hProduct-contact cleanSAP PP-PI recipe · cleaning validation
12hValidated aseptic cleaningSAP PP-PI recipe · cleaning validation

Applied when the incoming product differs from the previous one on the same equipment. Shared dispensing and secondary packing use a 1–2h line clearance instead.

MarketsAssumption

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India18 d3 / 5 dTemperature-controlled roadPlanner estimate · forwarder history (Assumption)
Kenya28 d18 / 26 dSea reefer · temperature-controlled · via MombasaPlanner estimate · forwarder history (Assumption)
Uganda28 d23 / 32 dSea reefer · temperature-controlled · via Mombasa + inland KampalaPlanner estimate · forwarder history (Assumption)
Tanzania28 d20 / 28 dSea reefer · temperature-controlled · via Dar es SalaamPlanner estimate · forwarder history (Assumption)
Nigeria28 d26 / 36 dSea reefer · temperature-controlled · via Lagos-ApapaPlanner estimate · forwarder history (Assumption)
Ghana28 d24 / 34 dSea reefer · temperature-controlled · via TemaPlanner estimate · forwarder history (Assumption)
Côte d’Ivoire28 d31 / 41 dSea reefer · temperature-controlled · via Le Havre, France → Abidjan (+7d transshipment)Planner estimate · forwarder history (Assumption)
Cameroon28 d33 / 43 dSea reefer · temperature-controlled · via Le Havre, France → Douala (+7d transshipment)Planner estimate · forwarder history (Assumption)
Philippines28 d18 / 26 dSea reefer · temperature-controlled · via ManilaPlanner estimate · forwarder history (Assumption)

New quotes assume packaging material is not in stock. Committed orders flagged "PM not in stock" receive it in 10 days.

QC & QA resourcesAssumption

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HPLC instruments682% / 62% / 70% / 48% / 56% / 45% · LIMS workload (Assumption)
QC analysts872% / 50% / 65% / 58% / 45% / 78% / 55% / 60% · Dissolution, pH & microbial limitsLIMS workload (Assumption)
Ophthalmic sterility testing2 sessions/day × 4 batches2–3 of 4 slots per session used by other ophthalmic batchesLIMS session plan (Assumption)
QA reviewers (batch record review 4h)1—QA roster · Planner estimate

When several units are free, the least-loaded one is used. Incubation (sterility 14 days, microbial limits 4 days) is elapsed time and does not occupy capacity.

QC test definitionsAssumption

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AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
DissolutionAnalyst6h—LIMS method master
Related substancesHPLC4h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
pHAnalyst2h—LIMS method master
Microbial limitsAnalyst1h4 dLIMS method master
AssayHPLC3h—LIMS method master
Related substancesHPLC4h—LIMS method master
pHAnalyst2h—LIMS method master
Ophthalmic sterility test (14-day incubation)Isolator session3h14 dLIMS method master

Scheduling rules

Finite-capacity forward scheduling in working hours (20h = 1 day, 06:00 start). Every machine and QC unit carries reserved blocks for other skus (domestic mts) (assumption). Plan orders are sequenced by due date and released just in time. A quoted order is placed behind the plan orders ahead of it (Urgent: none, High: those due earlier, Normal: all), then in confirmation order; confirming freezes that position, so the scheduled date equals the quoted P50. Each batch step goes on the earliest-available eligible equipment inside its GMP block, with changeovers when the product changes. API gates dispensing; packaging material gates packing steps. QC tests start in parallel after manufacturing, then sign-off, QA batch record review and release. P50 uses P50 QA/transit; P90 adds the P90 deltas plus a 15% breakdown buffer on the manufacturing span. Load is always measured over the next 60 days.