GMP Testing
With the acquisition of Averica by Neopharm Labs in 2017, we now offer full GMP analytical development, testing and program support across the entire timeline of product development. Neopharm Labs is Canada’s leading contract laboratory, providing reliable GMP quality control testing and creative R&D solutions. They are FDA and Health Canada compliant, licensed for handling controlled substances (narcotics), precursors, cannabis, and cytotoxic substances.
Through this acquisition, our capabilities and services now include:
GMP QC Testing
Chemistry & Chromatography
Neopharm’s Chemistry group uses a wide range of methods to test raw materials, finished products and packaging components in accordance with compendial procedures. Over the years, Neopharm has successfully developed/validated/transferred in excess of 4,000 HPLC, GC or other chemistry analytical procedures.
Microbiology
Neopharm offers complete microbiology and sterility testing to help ensure the safety of various products and ingredients. Their experienced microbiology team can perform a wide range of compendial assays.
Neopharm Labs continues to be a leader in pharmaceutical analysis, most recently investing in a MALDI TOF (Vitek MS) providing fast, complete, robust and accurate identification.
GMP R&D Testing
As a complement to routine quality control testing, Neopharm’s experienced teams of R&D scientists provide solutions for structural characterization, method development, verification, validation or transfer, and address the most complex analytical challenges that arise during product development. They also perform technological transfers of existing methods from other laboratories and have a vast expertise in cleaning validation and disinfectant efficacy study design.
GMP Stability Testing
Neopharm offers a full range of stability testing and storage services to meet the performance needs of their clients.
- A full range of Environmental conditions for all ICH Zones
- Flexible incubators to perform stability studies under stress conditions
- In-use stability studies to simulate patient use of drug product
- Stability trends to compare different packaging materials and container closure systems
- A 24/7 monitoring system and alarm call-out system, your products are kept in the proper conditions, compliant with 21 CFR Part 11.
GMP Quality Assurance & Consulting
We are committed to providing our clients with the highest quality in analytical (chemistry, chromatography, microbiology), consulting, stability and R&D services.
We strive to respect client timelines, as well as the accuracy and integrity of all data generated while performing tests or projects. We pride ourselves in ensuring our facilities, equipment, records and procedures are maintained in accordance with applicable regulatory and compendial requirements with respect to the Client’s needs.
Neopharm Labs offers consulting services for quality assurance and regulatory requirements to the pharmaceutical industry. We assist our clients in various aspects of their quality assurance programs, including assisting them in meeting GMP requirements, developing Standard Operation Procedures (SOP), preparing for regulatory inspections and managing product and license submissions.
Regulatory Consulting
Our team at Neopharm Labs includes industry experts with significant regulatory experience capable of assisting our clients with respect to assessing requirements and developing:
- Stability programs in accordance to ICH Q1A, WHO and other regulatory requirements
- Validation and method transfers
- Regulatory compliance for Canada, US, Central & South America, Europe and Asian markets