Questionnaire -

YOUR PROFILE

What is your function in the company? *

Scientist

PAT expert

Engineer

Department Manager (Production, ...)

Other (please specify)Other (please specify)

Industry type * Industry type

Which department do you belong to? *

R&D / Pilot plant

Industrialization / Scale-up / Product transfer

Manufacturing

Process monitoring / Process optimisation

Quality Control / Quality Assurance

Clinical Trials

Formulation

Packaging

Other (please specify)Other (please specify)

Does your company manufacture OSDs in batch or continuous mode? *

Batch Manufacturing

Continuous Manufacturing

CONTINUOUS MANUFACTURING

Is your company planning continuous production in the future? *

Yes

Maybe

I don't know

If so, when does your company plan to go into continuous production? *

< 5 years

Between 5 and 10 years

> 10 years

What drawbacks would prevent you from opting for continuous? *

Your process does not allow it

Impossible budget-wise

The transition would require too many resources (time, workforce...)

Other (please specify)Other (please specify)

YOUR QUALITY CONTROL PROCESS

How do you currently assess the batch quality? *

Off-line, using a physical parameters tablet testing (Weight, Thickness, Diameter/Length, Hardness) in a production lab

At-Line using IPC “In Process Control”, using a physical parameters tablet testing (Weight, Thickness, Diameter/Length, Hardness) connected to the tablet press/capsules filler

API’s fraction measurement in a separate analysis laboratory decentralized from the production area throughout the HPLC method

API’s fraction measurement at line

Dissolution measurement in a production lab

Dissolution measurement in a separate analysis laboratory decentralized from the production area

Friability testing in a production lab

Moisture content measurement in the production lab using a thermogravimetric method

Moisture content measurement in a separate analysis laboratory decentralized from the production area

In your company, are potential impurities tested on raw materials or finished products? *

Raw materials

Finished products

No test

ISSUES

What difficulties have you encountered in your quality control strategy? *

Ensure on-time regular sampling testing

Data integrity, data management, and/or report consolidation

Delay from the decentralized lab to attest final quality

Too high or too low number of samples tested

Other (please specify)Other (please specify)

What happens to the rejected batches? *

Batch is discarded

Batch is double-checked

We don't face this issue

CONSIDERATIONS FOR THE FUTURE

Would you be interested in using external services for product recovery? *

Yes

In your opinion, would it be useful to use PAT tools instead of IPC equipment to assess batch quality? *

Yes

Please justify:

What are the challenges to implement PAT?

YOUR QUALITY CONTROL PROCESS

How do you currently assess the quality in continuous? *

Off-line, using a physical parameters tablet testing (Weight, Thickness, Diameter/Length, Hardness) in a production lab

At-Line using IPC “In Process Control”, using physical parameters tablet testing (Weight, Thickness, Diameter/Length, Hardness) connected to the tablet press/capsules filler

API’s fraction measurement in a separate analysis laboratory decentralized from the production area throughout the HPLC method

API’s fraction measurement at line

Disintegration measurement in a production lab

Dissolution measurement in a separate analysis laboratory decentralized from the production area

Friability testing in a production lab

Moisture content measurement in the production lab using a thermogravimetric method

Moisture content measurement in a separate analysis laboratory decentralized from the production area

PAT sensors inbuilt in the line

What are the challenges to implement PAT?

Where are the sensors located in the line? *

After granulation

Inside dryer

After drying

After blending of APIs

After powder transfer/in the press hopper

In the paddle feeder of the press

On finished tablet

In the coater

On coated tablet

If PAT sensors are used in your line for intermediate monitoring, which one(s)? *

NIR

Raman

LIF (Laser Induced Fluorescence)

Microwave

OCT (Optical Coherence Tomography)

Laser Diffraction, Dynamic Light Scattering, ... (for particle size distribution)

Other (please specify)Other (please specify)

To which extent do you struggle with the following criteria during sensor measurement?

Low difficulty

Medium difficulty

High difficulty

Unstable measurement due to process environment

Low difficulty

Medium difficulty

High difficulty

APIs low concentration

Low difficulty

Medium difficulty

High difficulty

APIs signals overlapping

Low difficulty

Medium difficulty

High difficulty

Non-portability

Low difficulty

Medium difficulty

High difficulty

Sensor's model maintenance

Low difficulty

Medium difficulty

High difficulty

Scale-up ability between R&D, pilot and commercial manufacturing

Low difficulty

Medium difficulty

High difficulty

Sensor failure causing product waste

Low difficulty

Medium difficulty

High difficulty

Sensor failure causing line downtime

Low difficulty

Medium difficulty

High difficulty

When collecting data from PAT, would you consider to: *

Record all data about out-of-specification material/product

Record production statistical data only (including average, standard deviation, trends, ...)

Record all produced raw data (including spectra,...)

Do you also test finished tablets? *

Yes

What do you test on the finished tablets? *

Weight, Thickness, Diameter/Length, Hardness) - at line using physical parameters tablet testing

API’s fraction

Content Uniformity

Dissolution

Friability

Moisture

Additional testing about API’s content (through HPLC)

How do you measure dissolution?

Off-line in a laboratory

Predictive modelling

Other (please specify)Other (please specify)

CONTINUOUS TESTING

Which CQAs would you like to have non-destructively tested? *

Tensile strength

Porosity

Dissolution

Hardness

Disintegration

Other

If other, please specify: *

How many finished products are controlled during CM? *

< 20 tablets per hour

20-40 tablets per hour

40-60 tablets per hour

> 60 tablets per hour

100% of the production

Do you think that you will be able to increase the tolerance band in relation to the quantity of product controlled? *

Yes

Do you think increased sampling can be an asset in guaranteeing even greater quality? *

Yes

No (please explain)No (please explain)

If so, what would be the additional benefit(s) of testing a larger number of samples? *

Reduce the rejection strategy for finished products and therefore waste

Reduce laboratory testing time and chemical waste

Shorter downtime in the process, allowing further continuous manufacturing (i.e. coating or packaging)

Facilitate direct release

If you intend to continue testing using sampling method, which CQAs would you like to test?

Not important

Important

Highly important

Weight

Not important

Important

Highly important

Thickness

Not important

Important

Highly important

Diameter/Length

Not important

Important

Highly important

Hardness

Not important

Important

Highly important

API's fraction

Not important

Important

Highly important

Content Uniformity

Not important

Important

Highly important

Disintegration

Not important

Important

Highly important

Friability

Not important

Important

Highly important

Moisture

Not important

Important

Highly important

Tensile strength

Not important

Important

Highly important

Dissolution

Not important

Important

Highly important

Porosity

Not important

Important

Highly important

How do you think Quality Control will evolve in the coming years?

Name *

Name

First

Last

Company

Email *

Terms & Conditions: *

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I agree to be contacted for panel discussions in May and June.

I'm interested in further collaboration with academic institutions in the field of quality control and real-time release testing.

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About the questionnaire

YOUR PROFILE

CONTINUOUS MANUFACTURING

YOUR QUALITY CONTROL PROCESS

ISSUES

CONSIDERATIONS FOR THE FUTURE

YOUR QUALITY CONTROL PROCESS

CONTINUOUS TESTING