What to Know Before Committing

Natural Products INSIDER

June, 2011
Top 10 Questions to
Ask Contract Manufacturers
Ask These Critical Questions
Before Signing a Contract
Brand owners that ask the correct questions
up front will be able to better choose a
qualified contract manufacture that can work
with their specific needs.
These critical questions regarding materials,
suppliers, equipment, formulation techniques
and written procedures will help answer the
big question: Will this partnership hurt or
help my business?
1.Can you produce
the desired product?
It may seem obvious, but contract manufacturers differ in their abilities to
produce particular areas of the market, such as tablets, capsules, powders or
liquids. Make sure the manufacturer has the auxiliary capabilities to handle the
delivery form including lab testing, R&D services, label design/printing and
packaging.
Adapted from Turnkey Contract Manufacturing by Bob Dunn
2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs (current good
manufacturing practices).
Adapted from Turnkey Contract Manufacturing by Bob Dunn and
Beyond cGMPs to Contaminant-Free Contract Manufacturing by Joe Archer


2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn
3. Are you happy working here?
Talk to the staff to get a sense of their level of knowledge and expertise. Pay
attention to the manufacturing employees to see if they seem to enjoy their
work. Manufacturers with an unhappy workforce tend to have more turnover
and are more likely to encounter related production problems.
Adapted from Beyond cGMPs to Contaminant-Free Contract Manufacturing by Joe Archer

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn
4.Can I see the specs for the
raw materials included in my
product?
The contract manufacturer should
provide a copy of a specification sheet
with all of the testing that is expected
to be performed plus the criteria for
passing or failing the raw material,
including identity, strength and potency,
and continuation status.
Adapted from Inquire About Incoming Ingredient Inspection by Kevin Cloud

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn

5.What instruments do you use to
identify incoming raw materials?
The manufacturer should provide copies of the qualifications for each instrument
listed. A qualification is made up of three distinct parts: installation qualification
(IQ), operational qualification (OQ) and performance qualification (PQ). Typical lab
instruments include high-performance liquid chromatography (HPLC), gas
chromatography (GC), ultraviolet visible spectroscopy (UV/Vis), fourier transform
infrared spectroscopy (FTIR), high-performance thin layer chromatography
(HPTLC), melting point (MP), microscope and near infrared spectroscopy (NearIR).
Adapted from Inquire About Incoming Ingredient Inspection by Kevin Cloud

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn

6.What types of methods
do you use to assay incoming
raw material?
A method, standard operating procedure
(SOP) or set of directions, is essential to
assay a sample, and it should be
scientifically valid. Make sure the raw
materials come from suppliers that can
be qualified under the Part 111
regulation. Some recognized scientific
compilations of methods are the U.S.
Pharmacopeia (USP), American Oil
Chemist Society (AOCS), Japanese
Pharmacopeia (JP) and British
Pharmacopeia (BP).
Adapted from Inquire About Incoming Ingredient Inspection by Kevin Cloud

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn
7. Do you provide packaging and
advice on finished goods labeling?
Many outside label vendors are not familiar with the regulatory processes that
affect the dietary supplement industry. A contract manufacturer with the expertise
can not only design and print custom labels, but also watch for regulatory
compliance. Labeling regulations are quite extensive, with primary label
regulations for dietary supplements found at 21 CFR 101.36. However, additional
labeling regulations for conventional foods also apply, principally found in 21 CFR
101 and elsewhere.
Adapted from Getting to Worry-Free Manufacturing by Richard Mihalik and
Essential Questions Related to cGMP-compliant Manufacturing by Vince Paternoster


2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn

8.If the product takes off, do you
have the capacity to meet the
increased demand?
Asking about future planned expansions in production capacities can determined
whether the contract manufacturer can keep up with a successful product launch.
Also, ask about planned equipment upgrades and improvements.
Adapted from Getting to Worry-Free Manufacturing by Richard Mihalik

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn

9.Are all packaging components
suitable to protect the product and
for storage?
Packaging materials that comes in
contact with the product need to be
free of filth and potential
contaminants. Verify companies
supplying packaging materials that
are in direct contact with the
finished dietary supplement are
knowledgeable about the 21 CFR
regulations that apply to those
components.
Adapted from Essential Questions Related to cGMP-compliant Manufacturing by Vince Paternoster

2. Can I visit your facility?
Visiting the manufacturing facility can ensure everything is legitimate. Make
sure the facility is in good working condition, well laid out, clean, conducive to
producing the required products and built to meet cGMPs.
Adapted from Turnkey Contract Manufacturing by Bob Dunn
10.Are you ready for an
FDA cGMP inspection?
An FDA inspection, the area of focus
for Part 111 cGMP compliance, will
include a thorough inspection of the
facility, operations, components,
quality control (QC), written
procedures, documentation/record
keeping, etc. The inspection also
includes an intensive series of
questions that detail each subpart of
the cGMP rule. Of particular
importance is whether all employees
have completed cGMP training.
Adapted from Essential Questions Related to cGMP-compliant Manufacturing by Vince Paternoster
Asking questions about raw material sourcing, label issues, production
capacity and cGMP compliance can help brand marketers ensure their
contract manufacturers are fully in compliance with FDA regulations on
dietary supplement manufacturing.

Asking first can prevent painful situations later ranging from lost time to FDA
product seizure. In this case, what you dont know can hurt you. But having
the correct information can get you to worry-free contract manufacturing and
product success.



The More You Know
Thanks for viewing
Top 10 Questions to Ask Contract Manufacturers
Please download for your records
Brought to you by:
For more, go to NaturalProductsINSIDER.com