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WHO-GMP Standards for Oncology Drug Manufacturing

Posted by

Sandeep Mishra

WHO establishes stringent parameters for manufacturing oncology medicines.

The anti-cancer drugs are highly toxic, potent medicines.

They are developed in controlled environments with safety parameters.

Facility design/containment systems –

Dedicated facilities-

These are separate blocks or rooms for manufacturing toxic drugs.

Dedicated blocks for multi-step processes like granulation, blending, and tableting.

Segregated material flow
Restricted access barrier system
Air-lock systems between multi-chamber rooms.
Air-tight architecture, sealed floors and roof

Air conditioning systems (HVAC) –

It is used for clean room standardization and environmental isolation.

Maintaining pressure variants in toxic zones.
HEPA filters for air filtration.
Unidirectional airflow
Temperature and humidity control

Personnel Safety –

The anticancer drugs are highly toxic and irreversibly damage living tissue.

The manufacturers must ensure high safety measures for the workers.

Cytotoxic drug handling training must be provided.

Use of protective gear /garments
Air borne drug /particulate matter monitoring.
Decontamination facilities like dedicated shower or eye wash stations.

Validation process-

It ensures that each activity and process is under permissible limits.

Equipment /instrument validation
Operational validation
Design validation
Installation validation
Performance validation
Cleaning validation

Waste product management –

The residue of the oncology drugs is highly toxic.

WHO recommends safe disposal of toxic components.

Separate in/out bags.
Chemical treating systems
Segregation for biological, hazardous, or general waste
Fumigation exhausts to neutralize toxic vapors.

Why is a stringent regulatory framework required for oncology drug manufacturing?

The manufacturing process of oncology drugs demands high precision and sterility.

These are cytotoxic drugs.

These are lethal and directly kill viable cells.

Requirement for precision-

They have narrow safety margins.

Large doses damage the organs.

A lowered dose may lead to treatment failure.

Safety of personnel-

Spilling or touching the drug component may damage human cells.

It can cause serious complications.

Dedicated flow lines-

This prevents cross-contamination.

A trace of the cytotoxic drug clinging to the pipes may get incorporated into other medicines through the same pipeline.

The Air flow systems-

Any vapor or fumes of the toxic product in the air may lead to hazardous results when inhaled.

The particulate matter in the air may contaminate other general products.

Which is the leading WHO-GMP certified oncology medicine manufacturer?

Aprazer Healthcare is an oncology medicine manufacturer.

Globally recognized for manufacturing top quality pharmaceuticals, we are the leading oncology drug exporters.

We are trusted for our commitment to quality (WHO-GMP standards).

We manufacture a wide range of oncology drugs.

Oncology orals/Oncology injectable

Our flagship products include chemotherapy injectables-

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