Yushu Zhu

Ruvian Technology Ltd.

China

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Introduction

cGMP Manufacturing Of E-liquid

Conclusion

Introduction

Introduction

Within the world community, E-

Cigarettes become more and more

popular for either as an alternatives of

smoking or quit smoking

E-Cigarette’s product standards need

to be defined and recognized

Introduction

Directly into the lungs

E-Liquid is a major component in E-Cigarettes,

which is inhaled into human body directly

Introduction

Although E-Liquid is not classified

as a drug or food, Good

Manufacturing Practice (GMP)

guidance as it’s applied in global

pharmaceutical industry provides

a useful framework of reference

for exploring potential standards

for manufacturing E-Liquid

cGMP Manufacturing Of E-Liquid

cGMP Manufacturing

Of E-Liquid

Raw Materials

- Undiluted Nicotine is an API covered in EP/USP. Principle of cGMP such as ICH Q7 is proposed to be applied for the suppliers of Nicotine

- Nicotine CEP issued by EDQM or USFDA DMF may be required

if appropriate for EU and US market respectively

- PG/VG shall use EP/USP grade

- Nicotine/PG/VG shall from qualified suppliers approved by QA

Establish in accordance with the pharmaceutical grade requirements

Testing in GMP QC Lab before it’s be used for manufacturing, and the test results should conform to the established specification

- Meet with material storage requirements

- Nicotine must be controlled as highly toxic product by double check & double lock management

Nicotine

PG,VG

Specification

Test

Storage

Facilities And

Equipment

Environment

• The E-Liquid is manufactured at the specific Class D clean area with independent air-condition system to avoid contaminants

Equipment and pipeline

• The equipment and pipeline, which are in contact with materials, shall made by stainless steel 304/316L

PPE

• Glove box and long pipe respiratory system are installed to keep the safety of operators during operation

Documentation

Master Batch Records of E-Liquid are established by Production Department and become effective once approved by QA.

The records shall be archived.

Test Records of E-Liquid are established by QC and become effective once approved by QA. The records shall be archived.

The Production operators and QC analysts shall be trained & qualified before operation. Training record shall be filed

Master

Batch

Records

Test

Records

Training

&

Qualify

Release Of

Final Product

Warehouse keeper release the final

products according to Release Order

QA response to review Master Batch

Records and Test Records, and then QA issue Release Order

for final product

Tested in GMP QC Lab with validated methods

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Complaint

And Recall

Complaint

• All quality related complaints, whether received orally or in writing, should be recorded and investigated according to a written procedure

Recall

Recall triggered by any batches has problem, such

as detection of substances of concern, leaking

devices, and product safety etc.

• Recall from sale across the whole supply chain

• Recall from consumers who have purchased

Conclusion

cGMP guidance such as ICH Q7 in

pharmaceutical industry provides a useful

reference for E-Liquid manufacturing standards

Advancing a product standard strategy that yields

strong standards to improve public health and can

withstand legal challenge

Conclusion

It is our responsibility to manufacture safe,

effective and high quality E-Liquid/E-Cigs

Control the quality of the materials and the

environment of manufacturing to control the

impurities and contaminants (including E-Liquid

ingredients and potential microbial contaminants)

yushu@ruvian.com

ruvian.com