Industry profile · IK-FAR

The plant dashboard for pharmaceuticals and cosmetics

GMP, cleanrooms and validation of every change.

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  • 9 standard rooms loaded
  • 6 lockout energy sources
  • 5 reference standards
Illustration of a pharmaceuticals and cosmetics facility

How the work is done in pharma

Classified rooms and a documented process: here the procedure is not a help, it is a requirement. Everything that touches the product is recorded and verified.

The jobs that set the pace

  • Cleanroom production
  • Validated cleaning and disinfection
  • Maintenance in a classified zone
  • Equipment calibration and qualification
  • Handling of potent active ingredients

The rooms it comes with as standard

  • Class C cleanroom
  • Class D cleanroom
  • Personnel airlock
  • Granulation
  • Compression
  • Secondary packaging
  • Quarantine store
  • Utilities · purified water
  • Quality control

Lockout/tagout, with isolation point and verification

The dashboard does not ask “what energies does your equipment have?”: in the pharma profile they are already there, each one with where it is isolated and how you check that it is isolated. It is what an inspection asks to see in writing.

EnergyIsolation pointVerification
ElectricalRoom panel isolatorVerification of the absence of voltage
PneumaticRoom compressed air isolation valveBleed and gauge at 0 bar
Clean steamPure steam header valveBleed and temperature below 45 °C
Purified water / WFIDistribution loop valvesDraining and conductivity check
Product and dustTransfer line isolationValidated cleaning and surface sampling
Stored mechanical energyLockout of the tablet press carriageChock check

The high-risk procedures, written down

Five procedures specific to pharma, written in the vocabulary of the sector and available inside the dashboard so you can adapt them to your plant.

Access to a classified room

Gowning through airlocks and a controlled flow of people and materials: a shortcut contaminates the whole batch.

Containment of potent APIs

Work with an isolator or positive-pressure PPE according to the permitted exposure level.

Lockout with batch integrity

Before opening a piece of equipment: which batch is inside and who releases the line afterwards.

Calibration and qualification

Verification here is what releases the work: without a certificate there is no production.

Data integrity during the intervention

What is done is recorded there and then, with a signature: memory is not a record.

Equipment and reference regulations

Equipment typical of this profile

  • Rotary tablet press
  • Fluid bed granulator
  • Coating pan
  • Purified water system
  • Autoclave
  • Aseptic filler
  • Blister machine
  • Air handling unit (AHU)

Regulations that frame the work

  • NCF · Good Manufacturing Practice (revised Annex 1)
  • RD 1345/2007 · medicinal products for human use
  • ISO 14644 · cleanrooms
  • RD 1215/1997 · work equipment
  • RD 664/1997 · biological agents

Current references the dashboard uses to organise the documentation. IndustriaKit is a documentation tool: it does not replace the risk assessment or legal advice.

Documentation specific to the sector
  • Equipment qualification (IQ/OQ/PQ)
  • Validated cleaning protocol
  • Room classification certificate

What the dashboard does with all this

Contractors and coordination of activities

Contractors working on site join free, upload their documentation and the traffic light decides who can work. RD 171/2004 coordination with minutes and signature.

Permits with QR codes

Work permit with a printable notice: in the field it is scanned and signed from a phone. LOTO warning when the job calls for it.

Maintenance and OEE

Queue prioritised by criticality, statutory maintenance schedules with their date, counters based on real usage and an OEE panel per line with a Pareto of stoppages.

Personnel and training

Fitness for work, training and health surveillance by job role, with the medical data kept outside the dashboard by design.

Open it with the pharma profile and compare it with your folder

The demo opens with no card and no sales call. You choose this same sector and walk into a plant that looks like yours, with sample data you can play with without breaking anything.

Enter the demo   See the dashboard pricing →

The other industries in the dashboard

Each profile brings its own vocabulary, its own areas, its own energies and its own procedures. There are sixteen.