| Are
you a GMP laboratory? |
| The Pharmaceutical
Division at Lancaster Laboratories performs all work in
accordance with cGMPs. We take compliance with cGMPs very
seriously and provide training for our employees on a routine
basis. |
| Are
you registered with the FDA? |
| Yes, we
are. Our registration number is 2513291, and we have had
FDA inspections of our facility about every two years. |
| Can
you handle controlled substances? |
| Yes, we're
registered with the DEA (RL 0329068) and are approved to
handle Schedules I through V. Please remember that controlled
substances in Schedule I or II cannot be submitted to the
laboratory without the DEA Form 222. Please call your project
manager to request a form as well as prior to sending any
schedule controlled substance. |
| Whom
should I talk to when I call Lancaster Laboratories? |
| If you
know that you or someone in your company has previously
sent work to Lancaster Laboratories, you should ask to speak
to your project manager. That person will be most familiar
with your account. If you don't know your project manager's
name, our operators can help you. If you're new to Lancaster
Laboratories, ask to speak with someone in pharmaceutical
business development. |
| How
do I open an account with Lancaster Laboratories? |
| When you're
ready to submit samples for testing, you can open an account
with us by calling and asking for business development.
A trained representative will discuss your project requirements
and obtain the information needed to open an account. If
necessary, this person will also prepare a quotation and
send you the supplies you'll need. |
| Do
you have specific requirements for submission of samples? |
| All samples
for pharmaceutical analysis should be submitted with a signed
copy of the quotation we prepared for you. (If you require
a purchase order, please include that on the quotation or
with your sample paperwork). Also, we'll need to know who
should receive the invoice and who should receive the final
report. We've developed a New Project Checklist that gives
you a detailed overview of the sample submission process.
It may be helpful as you plan your next project. Our Sample
Submission Form is also a great tool when sending work to
us. |
| Can
you pick up samples at my facility? |
| Lancaster
Laboratories provides pick-up service to clients within
our
same-day courier service area. The benefit to you is
that your samples return to the laboratory the same day
they are picked up, and you don't have to deal with packing
samples for travel via an overnight courier. Our service
area for pick-up includes: central and eastern Pennsylvania,
Delaware, New Jersey and Maryland. You can get more details
by calling your project manager or our Transportation Department.
|
| What
are your business hours? |
| Lancaster
Laboratories operates three work shifts; however, our business
hours are from 8:00 a.m. to 5:00 p.m. (Eastern Standard
Time), Monday through Friday. During these hours, your project
manager or technical project coordinator is available to
discuss your projects. Samples can be dropped off at our
facility anytime, seven days a week. |
| Besides
the telephone, phone, and fax, are there other ways that
I can communicate with Lancaster Laboratories? |
| You can
e-mail us. All of our business development staff, project
management staff, managers, and technical leaders have Internet
e-mail addresses. We'll be happy to provide on-line addresses
for the people you will be working with. |
| Do
you subcontract work? |
| Due to
the compliance issues involved, Lancaster Laboratories does
not subcontract any pharmaceutical work without client approval.
|
| Do
you have stability chambers on-site? |
| Lancaster
Laboratories has a variety of stability storage chambers
(22) in a locked and controlled-access building next to
the main laboratory building. Our chambers meet the current
ICH guidelines. And we can customize chamber conditions
to meet your particular requirements. |
| Can
I audit your facility? |
|
Lancaster Laboratories welcomes your audit. We're proud
of our staff and facility and believe that an on-site
visit can be an important tool when choosing a contract
laboratory. A visit gives you a chance to tour our laboratory
areas, meet with our QA staff to review our SOPs and QA
program, and discuss specific projects with our technical
staff. The first one-day audit of our facility is complimentary.
If you're unable to visit, we can supply you with a copy
of our Pharmaceutical Sciences Qualification Manual. It
will give you a thorough overview of our quality operations.
|