The 47 regulatory controls Pharmatica records.
Each control names the Malaysian rule behind it, what the system records and where it happens.
17
Pharmatica Retail controls
16
Pharmatica Distribution controls
14
Pharmatica Logistics controls
12
Malaysian instruments cited
Pharmatica Retail
R-01 · Batch and expiry capture at receipt
RecordedRetail warehouse goods receipt
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The register
Control inventory
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Choose your operation.
Retail shown. Each tab shows that operation’s controls only.
Pharmatica Retail — Pharmacy Management System
17 controls
| ID | Control | Instrument | What the system records | Where it happens |
|---|---|---|---|---|
| Stage · Supplier · 2 | ||||
| R-08 | MAL classification on the SKU | NPRA DRGD + CDCR 1984 | Registration number, product category, holder, status and effective dates | Retail product regulatory record |
| R-09 | Product-registration status check | CDCR 1984 | Registration number, registered particulars, status, source and last check time | Retail product approval queue |
| Stage · Warehouse · 5 | ||||
| R-01 | Batch and expiry capture at receipt | NPRA GDP 2018 | SKU, supplier, batch or lot, expiry, quantity, receipt time and receiving user | Retail warehouse goods receipt |
| R-02 | FEFO allocation | NPRA GDP 2018 | Eligible batches, expiry sequence, selected batch and any authorised exception | Retail warehouse allocation queue |
| R-03 | Quarantine and release | NPRA GDP 2018 | Batch status, inspection result, decision, reason, authorised user and timestamp | Retail warehouse batch status |
| R-04 | Storage-condition assignment | NPRA GDP 2018 | Product storage rule, location condition, placement decision and exception | Retail warehouse put-away |
| R-05 | Cold-chain excursion handling | NPRA GDP 2018 | Reading, limit, affected location, affected batches, quarantine and disposition | Retail cold-chain excursion case |
| Stage · Outlets · 1 | ||||
| R-10 | Licence expiry | CDCR 1984 + Poisons Act 1952 | Licence type, holder, premises, validity dates, status, owner and renewal evidence | Retail licence register |
| Stage · POS · 4 | ||||
| R-06 | Prescription Book entry (Form C) | Poisons Regulations 1952 | Date of sale or supply; serial number of the prescription entry; name and address of patient, recipient or person; name and quantity of poison or medicine supplied | Pharmacy Prescription Book |
| R-07 | Registered pharmacist attendance record (Form E) | Poisons Regulations 1952 | Attendance date, registered pharmacist name, identity card number, annual certificate number, time in and time out | Registered pharmacist attendance record |
| R-16 | e-Invoice submission | LHDN e-Invoice | Invoice code, type, issue date and time, supplier, buyer, lines, tax and validation result | Finance and MyInvois submission queue |
| R-17 | SST treatment by invoice line | Sales Tax Act 2018 + Service Tax Act 2018 | Tax type, classification, exemption, applicable rate, taxable amount and tax amount | Retail invoice tax review |
| Stage · Loyalty · 4 | ||||
| R-11 | Consent record | PDPA 2010 | Member, purpose, notice version, choice, collection channel and timestamp | CRM consent history |
| R-13 | Personal-data access and correction request | PDPA 2010 | Requestor, scope, identity check, received date, response and completion date | Data-subject request queue |
| R-14 | Personal-data access log | PDP Standard 2015 | User, role, member record, action, date, time and outcome | Security access audit |
| R-15 | Personal-data retention and disposal | PDPA 2010 + PDP Standard 2015 | Record class, retention rule, due date, hold, disposal method and completion evidence | Data-retention schedule |
| Stage · Control layer · 1 | ||||
| R-12 | Data Protection Officer applicability | PDPA 2010 + PDP Circular 1/2025 | Applicability basis: more than 20,000 data subjects; more than 10,000 data subjects whose data is sensitive personal data including financial information; or regular and systematic monitoring, assessed independently | Data-protection governance register |
Pharmatica Distribution — Pharmaceutical Distribution Management System
16 controls
| ID | Control | Instrument | What the system records | Where it happens |
|---|---|---|---|---|
| Stage · Importation · 5 | ||||
| D-01 | Import-licence validity | CDCR 1984 | Licence holder, premises, registered products, issue date, expiry and status | Import and regulatory licence register |
| D-02 | Registered-product scope on the licence | CDCR 1984 | Licence, registered product, registration number, authorised premises and status | Import licence product scope |
| D-03 | Shipment document set attached to batch | NPRA GDP 2018 + NPRA DRGD | Shipment, permit, customs document, CoA, MAL record and linked batches | Import shipment record |
| D-04 | Certificate of analysis attached to batch | NPRA DRGD | Certificate, product, batch, issuing laboratory, document date and review status | Import batch document review |
| D-15 | Product-registration renewal and change calendar | NPRA DRGD | Registration, holder, expiry, submission type, due date, owner, documents and outcome | Regulatory registration calendar |
| Stage · Warehouse · 3 | ||||
| D-05 | Arrival quarantine | NPRA GDP 2018 | Batch, receipt, quarantine reason, physical location, status and hold time | Distribution warehouse inbound quality |
| D-06 | Authorised batch release | NPRA GDP 2018 | Inspection evidence, decision, authorised user, reason, release time and batch status | Distribution warehouse release queue |
| D-07 | FEFO customer-order allocation | NPRA GDP 2018 | Order line, released candidate batches, expiry sequence, allocation and exception | Distribution allocation queue |
| Stage · B2B customer · 1 | ||||
| D-08 | Customer authorisation check | NPRA GDP 2018 | Customer, authorised premises, licence reference, validity, catalogue rule and check result | B2B customer compliance record |
| Stage · Delivery · 2 | ||||
| D-09 | Transport-condition assignment | NPRA GDP 2018 | Shipment, product condition, route, vehicle, carrier, dispatch time and exception | Distribution transport load plan |
| D-10 | Electronic proof of delivery | NPRA GDP 2018 | Shipment, recipient, signature, image, time, location, exceptions and linked batches | Distribution delivery evidence |
| Stage · Collection · 1 | ||||
| D-16 | B2B e-Invoice validation and submission | LHDN e-Invoice | Supplier, buyer, invoice reference, lines, tax, submission identifier and validation status | Distribution finance submission queue |
| Stage · Traceability · 4 | ||||
| D-11 | Batch genealogy | NPRA GDP 2018 | Every receipt, hold, release, movement, allocation, shipment and recipient by batch | Distribution batch genealogy query |
| D-12 | Recall recipient list | NPRA GDP 2018 + NPRA DRGD | Affected product and batches, customers, quantities, contacts and assigned recall tasks | Distribution recall workspace |
| D-13 | Recall reconciliation and closure | NPRA DRGD | Distributed, notified, recovered, outstanding and disposed quantities with closure approval | Distribution recall reconciliation |
| D-14 | Product-quality complaint record | NPRA DRGD | Complainant, product, batch, event, assessment, investigation, action and regulatory follow-up | Quality complaint case |
Pharmatica Logistics — Pharmaceutical Logistics Management System
14 controls
| ID | Control | Instrument | What the system records | Where it happens |
|---|---|---|---|---|
| Stage · Inbound · 2 | ||||
| L-01 | Inbound batch and expiry evidence | NPRA GDP 2018 | ASN, GRN, stock owner, SKU, batch, expiry, quantity and receipt time | 3PL inbound receipt |
| L-02 | Inbound inspection, quarantine and release | NPRA GDP 2018 | Inspection result, discrepancy, status, decision, authorised user and timestamp | 3PL inbound quality workflow |
| Stage · Regulated storage · 5 | ||||
| L-03 | Stock-owner separation | NPRA GDP 2018 | Owner on each bin balance, movement, allocation, adjustment, order and report | Multi-client warehouse inventory |
| L-04 | Mapped storage conditions | NPRA GDP 2018 | Zone, mapped limits, monitoring points, product rule, placement and review date | Regulated storage zone register |
| L-11 | Return authorisation | NPRA GDP 2018 | Client, product, batch, quantity, reason, authorisation, carrier and expected receipt | Reverse-logistics authorisation |
| L-12 | Returned-stock quarantine and disposition | NPRA GDP 2018 | Return receipt, batch, condition, quarantine, inspection, disposition and approver | Returns inspection queue |
| L-13 | Recall location and reconciliation | NPRA GDP 2018 + NPRA DRGD | Affected batches, stock positions, shipments, recipients, recovered quantities and closure evidence | 3PL recall workspace |
| Stage · Cold chain · 4 | ||||
| L-05 | Sensor calibration record | NPRA GDP 2018 | Sensor, location, calibration date, standard, result, certificate and next due date | Cold-chain sensor register |
| L-06 | Temperature monitoring and alert | NPRA GDP 2018 | Sensor, reading, timestamp, zone limits, breach duration, alert and acknowledgement | Cold-chain monitoring console |
| L-07 | Excursion affected-batch identification | NPRA GDP 2018 | Excursion interval, affected locations, batches present, quantities and quarantine tasks | Cold-chain excursion scope |
| L-08 | Excursion investigation and disposition | NPRA GDP 2018 | Investigation, evidence, affected batches, disposition, approver and closure time | Cold-chain excursion case |
| Stage · Fulfilment · 1 | ||||
| L-09 | FEFO fulfilment | NPRA GDP 2018 | Client order, released candidate batches, expiry sequence, selected stock and exception | 3PL fulfilment work queue |
| Stage · Delivery · 1 | ||||
| L-10 | Delivery-condition evidence | NPRA GDP 2018 | Shipment, vehicle, recipient, handover time, location, temperature and exceptions | 3PL electronic proof of delivery |
| Stage · SLA · 1 | ||||
| L-14 | NCII cyber-security incident record | Cyber Security Act 2024 | Incident, detection time, affected system, response, notifications, evidence and closure | Security incident register |
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How to use it
Control inventory
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Take this list to every vendor you compare.
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Ask where each control happens
A vendor should show you the screen and the record for each one.
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Check who signs
Each control names the person who approves it.
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Shared controls
Control inventory
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Three controls that cross all three systems.
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Recall
A recall stops the batch at every outlet, warehouse and customer.
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Batch status
On hold, released or blocked, shown the same everywhere.
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Temperature records
Readings stay with the batch from warehouse to delivery.
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