Quality

A quality system that follows every batch.

Quality at Amulya Labs is a set of controls applied to every batch, from the raw material that arrives at our gate to the documents that leave with the finished goods. Our manufacturing is GMP-grade and follows WHO-GMP, and our nutraceutical products are made under a central FSSAI licence.
How a batch is controlled

Six controls, from raw material to release.

1

Incoming material testing

Raw materials are tested against their specification before they are released for production. Material that does not meet specification is not used.
2

In-process checks

Checks are carried out at set stages of manufacture against the approved specification, so a deviation is caught while the batch is still being made.
3

Batch manufacturing records

Every batch is made against a batch record that documents the materials, quantities and process steps used, and who carried them out.
4

Batch tracking and expiry

Each batch is given its own batch number, manufacturing date and expiry date, tracked in our systems so any unit can be traced back to its batch.
5

Release with a certificate of analysis

A batch is released only when its results meet specification. Each batch is supplied with its COA.
6

Retained samples

Samples from every batch are retained, so a question raised after dispatch can be checked against material from the original batch.
Quality in practice

Controls applied on the floor and in the laboratory.

Laboratory bench with test tubes and sample racks (stock photo)
Large stainless-steel tanks in a modern production area (stock photo)
Automated liquid filling line in a manufacturing plant (stock photo)
Standards

The standards we manufacture to.

Certificates and licences that apply to your product category are shared with buyers on request.

WHO-GMP, GMP-grade manufacturing

Our manufacturing follows WHO-GMP requirements: controlled premises and processes, documented procedures and batch records, and quality checks before release.

Central FSSAI licence

Nutraceutical and food supplement products are manufactured under a central FSSAI licence.

Science-backed formulation

Formulations are designed on a scientific basis, with studies available through Amulya Research Centre when a product needs evidence.
Stability and shelf life

Shelf life backed by stability data.

The shelf life and expiry date we assign to a product are backed by stability studies, so the date on the pack reflects how the product actually holds up over time.
Documentation

Supplied with every order.

• Certificate of analysis (COA) for each batch
• Material safety data sheet (MSDS)
• Export documentation for international shipments, so buyers can complete their own regulatory checks with confidence
• Batch number, manufacturing date and expiry date for full traceability
• More detail on each document: Regulatory and export documentation
FAQ

Quality questions.

Is shelf life backed by stability studies?

Yes. The shelf life and expiry date of each product are backed by stability studies.

Is your manufacturing GMP compliant?

Yes. Our manufacturing is GMP-grade and follows WHO-GMP requirements, and our nutraceutical products are made under a central FSSAI licence. Certificates and licences that apply to your product are available on request.

What documents come with each order?

Every order is supplied with a certificate of analysis (COA), a material safety data sheet (MSDS) and the export documentation the shipment needs.

Can you trace a unit back to its batch?

Yes. Each batch has its own batch number, manufacturing date and expiry date, recorded in our systems and in the batch record, so any unit can be traced back to the batch it came from.

Do you keep samples of each batch?

Yes. Samples from each batch are retained, so any question raised after dispatch can be checked against material from the original batch.

Can I see your certificates before placing an order?

Yes. Share your product and destination market, and we will provide the certificates and licences that apply.

Need a document before you decide?

Share your product and destination market, and we will provide the certificates and documents that apply.