The document outlines the importance of analytical testing for pharmaceutical manufacturers, emphasizing the necessity of complying with FDA regulations throughout the drug development process. It highlights Impact Analytical's capabilities in providing comprehensive testing services, including various types of analyses and detailed reporting, while ensuring high-quality standards and strong partnerships with clients. The company offers a secure platform for monitoring project progress and emphasizes effective communication and consultation for tailored solutions.

1. Pharmaceutical
Testing
Analytical Testing for Pharmaceutical Manufacturers & CMO’s
a complete guide to testing requirements and what to expect
when partnering with Impact Analytical

2. Pharmaceutical Challenges
Analytical testing during the drug development process is required and governed by the
Food and Drug Administration (FDA). Although the FDA does not specifically detail how the
testing should be conducted, they do specify the depth of testing that’s required and how
your results must be documented.
Testing is required for both small and large molecule active pharmaceutical ingredients
(API’s) and finished drug products. Analytical testing is needed throughout
preclinical, phases I, II and III and can include:
•Molecular Characterization
•Method Development and Validation
•Stability Testing
•Batch Release Testing
•Raw Material Characterization
•Extractable and Leachable Analysis
•Impurity Identification

3. Choose Your Partner Lab Wisely
As a pharmaceutical manufacturer, it’s important to partner with a lab that operates under a
complete quality program and can perform testing per cGMP, following 21 CFR guidelines
spelled out by the FDA.
Why Impact Analytical?
We have the comprehensive quality program, experience and analytical expertise to deliver
the data your project requires. We have been audited by the FDA in 2008, 2009, and 2010
with no findings. Our laboratory is FDA registered, cGMP and GLP compliant, ISO
9001:2008 certified and DEA licensed.

4. Working Partnering with Us
At Impact Analytical, you don’t just work with us, but you are a partner of ours. We are an
extension of your company. We consult with you to understand your exact needs and deliver
compliant results on-time.
What to Expect
It all starts with a detailed conversation with your team to understand your project testing
requirements. Our analysts are available to consult in the very beginning stages and are
accessible throughout your entire project. You will be assigned a lead analytical expert who
can answer questions and keep you updated on the status of your project.
After initial discussions, we will provide you with a detailed and competitive quote that is
specific to your testing needs.

5. My Impact
When you submit samples you will receive your own secure My Impact account. My Impact
is our secure customer-only website that allows you to:
•Monitor your project through our laboratory
•Easily track the progress of sample testing
•Gain access to all of your samples, projects and completed reports at any time

6. Detailed Reporting
We don’t just give you raw data. Ever. Our reports are detailed, specific, and provide you
with clear answers to the problem being solved. Our reports won’t leave you asking more
questions but will provide you with the data you need to support your product through the
development life cycle. All reports include the following:
•Detailed Summary – summarizes the testing objective and results
•Experimental Conditions – we provide the details of how we prepared your samples,
how we ran the analyses and the conditions we used to test your materials.
•Results and Discussion – Results are described in detail and contain expert review by
our technical team. Results include all chromatograms and instrumental data
•Tables and Figures – Tables and charts are used to simplify findings and provide
details of the results that were obtained
•Quality Signatures – all reports are reviewed by our full –time quality department.
When testing under cGMP or GLP, all quality aspects are documented and detailed in
the report.
•

7. Customer Comments
•“Very accommodating with changing requirements. Good job at explaining results.
First time user. Did a great job for a client (who was somewhat demanding in their
expectations). Knowledgeable and professional. Would utilize services again (and
probably will in near future!) – Pharmaceutical Manufacturer commenting on assay and
impurity identification project
•“Laboratory was able to change the original methodology performed to accommodate
my needs and rapidly turn around my new results. Service was exceptional.” –
Biopharmaceutical Manufacturer commenting on acid analysis in protein
•“Thank you for the quick report turnaround for the IR interpretation. The results are
exactly what we were anticipating. We performed a controlled (forced) extraction on
polycarbonate bottles with rubber-lined caps using organic solvent. The BPA
derivatives were ID’d by GC-MS but were unsuccessful in identifying these nonvolatiles.
You guys have put a cap on two year’s frustration.” - a Top 50 Global Pharmaceutical
Company commenting on FT-IR analysis of polymer film and its extracted residue
•

8. Contact Us
Learn More at www.ImpactAnalytical.com/Pharma
Call 855-IA SOLVE (427-6583) to speak with one of our experts
Contact Us online
Request a Quote