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GPD Solutions

8025 Lamon Avenue

Skokie, IL 60077 US


GPD Solutions Services:

Chemistry Tests:
* Arsenic
* Elemental Analysis
* Gravimetric Analysis
* Acid Digestion
* Organic Volatile Impurities
* Hyaluronic Acid
* Phenol Formaldehyde Resin
* Polystyrene Standards
* Dextrose
* Methyl Cellulose
* Cellulose Acetate
* Adsorbable Organic Halogens
* Alcohols
* Alkalinity
* Aluminum Chloride Assay
* Other monographs and new test methods

Microbiological Tests:
* Sterility
* Microbial Identification
* Bioburden
* Disinfectant Efficacy
* Enrichment
* Temperature Mapping
* Environmental Monitoring
* Bacterial Endotoxin
* Turbidity
* Preservative Challenge Test
* Limulus Amoebacyte Lysate


CONSULTING DIVISION

Validation: Our services in this area include development, review, execution, and approval of master plans, protocols, and summary reports. We provide comprehensive and high quality services in the following areas:

* Computer Software
* Computer Hardware
* Manufacturing Process
* Test Method
* Autoclave
* Refrigerator
* Freezer
* Lab Equipment
* Cold Chain
* Cleanroom
* Aseptic Process
* In-Situ Efficacy Evaluation of Disinfectants
* Incubator.

Auditing: Each experienced GXP Auditor in our organization conducts an average of forty audits each year in both medical device and pharmaceutical industries worldwide. Regulation and Standards covered include:

* GCP
* GLP
* GMP
* ISO 9001:2000
* ISO13485:2003
* Canadian Regulation (CMDR) and
* MDD
* AIMDD
* IVDD

Consent Decree Management: We provide cost effective solutions in handling statement of work under consent decree.

Training: We provide GXP training with certificates of training recognized by industry third-party auditors. Our training programs include:

* GXP Overview
* Auditing Techniques and Guidelines
* CAPA Implementations
* OOS Investigations and Root-Cause Analysis
* Design Control
* Good Laboratory Practices
* Good Clinical Practices
* Good Documentation Practices
* Aseptic processing
* Validation
* ISO Registration Process
* Supplier Quality Implementation and Management.
* Quality Systems Architecture