Quality & Compliance
Ensuring Quality. Earning Trust.
We take a risk-based, science-driven approach to quality, designed around consistency, documentation, and transparency. Whether you’re sourcing Water for Injection (WFI), buffer solutions, or growth media, our commitment to quality ensures peace of mind.
Safety Data Sheets (SDS) for Water and Buffer Products
We provide general SDS templates for our Water for Injection (WFI), Sterile WFI, USP Purified Water, and Buffer Products that are publicly available and can be downloaded without logging in.
These templates include key safety and handling details such as:
- Product classification & intended use
- Physical and chemical properties
- Basic storage, disposal, and PPE recommendations
- General compliance references (USP, REACH, OSHA)
Customer-Specific SDS Access
- Log into their GMPLI account
- Navigate to their Order History or Product Dashboard
- Download SDS linked to their specific lot or product variant
This ensures:
- Accuracy and traceability of batch-specific documents
- Secure access to sensitive and proprietary specifications
- Controlled document versioning tied to the customer’s purchase or qualification process
All SDS documents are reviewed and updated in accordance with applicable guidelines (USP, OSHA, GHS, REACH), and previous versions are archived for regulatory traceability.
Built-In Quality, Trusted Results
At GMPLI, quality control is embedded in every step—from production to final release. Our certified lab uses validated systems and a secure LIMS platform to ensure consistent, accurate, and traceable results you can trust.
Certified Lab
ISO 9001 & ISO/IEC 17025 certified for quality and testing precision.
Validated Equipment
All systems are validated for reliable, repeatable performance.
Secure Data Management
Test data is stored in our Laboratory Information Management System (LIMS) for full traceability.
Easy Access to CoAs
Verified users can view Certificates of Analysis through our online portal.
Product Testing Matrix
Water
| Materials | Test 1 | Test 2 | Test 3 | Test 4 | Test 5 | Test 6 |
|---|---|---|---|---|---|---|
| Material A | — | — | — | — | — | — |
| Material B | — | — | — | — | — | — |
| Material C | — | — | — | — | — | — |
Media
| Materials | Test 1 | Test 2 | Test 3 | Test 4 | Test 5 | Test 6 |
|---|---|---|---|---|---|---|
| Material A | — | — | — | — | — | — |
| Material B | — | — | — | — | — | — |
| Material C | — | — | — | — | — | — |
Buffer
| Materials | Test 1 | Test 2 | Test 3 | Test 4 | Test 5 | Test 6 |
|---|---|---|---|---|---|---|
| Material A | — | — | — | — | — | — |
| Material B | — | — | — | — | — | — |
| Material C | — | — | — | — | — | — |
Quality You Can See
Flexible Audit Options That Fit Your Process
At GMPLI, we welcome customer audits. Whether remote or onsite. We’re here to support your compliance needs with transparency, preparedness, and professionalism
Desktop Audits
For customers conducting remote audits, GMPLI provides a pre-made audit package that includes commonly requested documents to support your qualification process.
Our audit package typically includes:
Company Overview – GMP Summary
ISO certifications and facility details
SOP summaries and training framework
Validation highlights and environmental monitoring approach
Sample CoAs and test method outlines To request the desktop audit package, please use the Request Audit form or contact our Quality Team directly.
Facility Audits
We invite customers to visit our Newark, Delaware site for an in-person audit experience.
During your on-site audit, you can:
Tour our manufacturing and cleanroom areas
Visit the Quality Control laboratory
Meet with the GMPLI Quality Team
Review documentation in a secure, designated audit room
Discuss validation, process controls, and change management protocols
Ready to Schedule?
To receive our desktop audit package or request an on-site visit, please complete the Request Audit form or email our Quality Team at qualityteam@gmpli.com. We’re here to support your team every step of the way.Facility
Facility Overview
GMPLI operates a sterile manufacturing facility designed to meet the highest industry standards.
Key Facility Features
- Built to comply with EU Annex 1 and FDA Sterile Facility Guidelines
- All systems are validated and calibrated regularly
- Cleanrooms are certified to maintain controlled environments
- Electronic Batch Records (EBR) ensure traceable, real-time production data
- Our facility in Newark, Delaware, supports consistent, compliant manufacturing for critical water and buffer products.
Stability Studies
Ensuring Quality and Longevity
GMPLI performs ongoing stability testing to ensure product quality, safety, and shelf-life under real-world and accelerated conditions.
Stability Study Highlights
Accelerated and real-time studies to assess product performance over time
Stability tested for both terminally sterilized and non-sterilized products.
Shipping simulation studies evaluate product integrity under transport conditions, including temperature and handling variations
All studies are conducted under controlled conditions following ICH and GMP principles. Stability data is available upon request to support customer qualification and risk assessments.
Paperless
Smart Systems. Smarter Decisions.
🖥
Digital Batch Records
Manufacturing records are captured in real time and reviewed electronically—no clipboards, no delays.
📂
MasterControl QMS
All quality events, CAPAs, audits, and document controls are managed in our validated electronic system.
📈
NetSuite ERP Integration
From inventory to financials, everything flows through a centralized ERP with real-time visibility.
🔒
Secure Audit Trails
Every action is timestamped, traceable, and audit-ready—ensuring full data integrity.
⚙️
Why It Matters
Going paperless means:
✔ Faster lot release
✔ Reduced manual errors
✔ Real-time collaboration
✔ Simplified compliance for audits and inspections
📁
Customer Access
Need a CoA or quality doc? Verified customers can access approved records securely via our online portal.
Environmental Monitoring
Ensuring Cleanroom & Product Integrity
At GMPLI, environmental monitoring (EM) is central to maintaining a controlled, compliant, and contamination-free manufacturing environment. Our program aligns with GMP and ISO standards, ensuring confidence in the safety and quality of every batch we produce.
Key Monitoring Areas
🦠
Airborne Particulates
We monitor both viable (microbial) and non-viable particles in classified areas using calibrated air samplers and particle counters.
🧫
Surface & Personnel Monitoring
Routine swabbing of surfaces and gowning checks help us verify cleanroom hygiene and personnel compliance.
🌬
Temperature & Humidity Control
Environmental parameters are continuously tracked to maintain tight control over critical manufacturing zones.
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Trend Analysis & Alerts
Our systems automatically trend EM data over time and flag out-of-spec events for immediate investigation and CAPA (Corrective and Preventive Action).
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EM Data & Compliance
All results are logged securely in our digital QMS and available for customer review upon request.
🔹 Fully GMP-Compliant
🔹 Supports Risk Assessments & Batch Release
🔹 Auditable Data for Qualification Packages
✅
Why It Matters
Environmental Monitoring provides the foundation for cleanroom control, enabling proactive quality assurance and safeguarding your product from contamination risks.
Terminal Sterilization
Media
There are a variety of aseptically filled products of available at GMPLI for Water, Buffer and Media.
All Environmental Monitoring (EM) medias are terminally sterilized (SAL of 10-6). Other medias may be aseptically filled (SAL of 10-3) or terminally sterilized (SAL of 10-6). There is a SAL (Sterility Assurance Limit) of 10-6. Products may be either autoclave or gamma irradiated.
Water/Buffer
For water and buffer, products may be aseptically filled or terminally sterilized. Terminally sterilized water/buffer products are gamma irradiated. Aseptically filled products have a SAL of 10-3 and terminally sterilized products have a SAL of 10-6. While the processing is identical for both aseptically filled and terminally sterilized products, the gamma irradiation gives the customer that extra level of assurance of no microbiological contamination.
Studies/Validations are performed both with and without gamma irradiation to ensure product integrity.
The following table provide a brief summary of aseptically filled vs. terminally sterilized products.
| Materials | Test 1 | Test 2 | Test 3 | Test 4 | Test 5 | Test 6 |
|---|---|---|---|---|---|---|
| Material A | — | — | — | — | — | — |
| Material B | — | — | — | — | — | — |
| Material C | — | — | — | — | — | — |
Support
Business Hours
Support is available: Monday – Friday | 8:00 AM – 8:00 PM (EST) Tickets submitted after hours will be reviewed the next business day.
🛒 Why Customers Return to GMPLI
📦 Reliable, scalable supply chain
🔍 Transparent documentation + CoAs
📈 Digital-first operations
🤝 Human support, every step of the way
Your next product deserves a partner as modern and precise as you are.