Services
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Services
In addition to being a contract manufacturer, Hanford also provides superior product development and support services to pharmaceutical companies of every size and function.
The company offers value-added consultative and hands-on services throughout all stages of a drug’s life cycle, from clinical trials through commercial scale-up assistance. General operational services such as employee training are also available.
Process and Equipment Validation:
Installation Qualification, Operation Qualification, Performance Qualification, Cleaning Validation, Instrument Calibration Program, Protocol Writing, Execution of Validation and Final Report Writing services are available.
Analytical Methods Development and Validation (Chemical and Microbiological):
Provides method development to current USP guidelines.
Quality Control Routine Testing:
cGMP compliant testing utilizing USP/NF compendial methods for Raw Material and Finished Product Testing. HPLC (isocratic and gradient) Gas Chromatography, Wet Chemistry and Physical Chemistry testing, Sterility Testing utilizing Isolator Technology, Kinetic and Gel Clot LAL testing capabilities.
Regulatory Support:
Assistance with ANDA and/or ANADA submissions as well as assistance with electronic submissions to OGD or CVM.
Product Stability Testing:
Stability testing throughout product shelf life including assay testing, physical and wet chemistry testing, impurity, LAL, and sterility testing.
Supplier Sourcing:
Provides expertise in sourcing Active Pharmaceutical Ingredients (API) and excipients.
Labeling Services:
Label development process (from design through printed material approval) of labels, inserts/outserts and cartons, expertise in FDA regulations, barcodes and RSS codes, review and proofreading skills, computer skills, current GMP procedures for label control, established relationships with printed material vendors and pharmaceutical contract customers.
GMP Compliance/Audit Support:
Provides on site or paper audits of manufacturing facilities to help ensure GMP compliance. Offers technical assistance in regards to GMP compliance as outlined in the CFR.
GMP Training:
GMP training is required at the time of hire and is completed as part of a two-day orientation. Continuing education in good manufacturing practices occurs throughout the year. Each employee is required to participate in a minimum of 3 continuing education courses. GMP courses provide instruction in job specific topics such as environmental monitoring and restroom sanitation as well as broader, theoretical subject areas including participation in external audits and inspections.
OSHA Safety Training:
Includes job specific information (i.e., forklift operation, respiratory protection) and general safety training (i.e., proper lifting techniques, chemical handling).
Quality Assurance Services:
Provides Batch Record Review, Document Approval and Quality Oversight of all Pharmaceutical operations.
Non-Sterile Penicillin Clinical Support:
Approximately 400 square feet of floor space with 10 foot ceiling height. Climate controlled - 65F @ 45% RH. Electrical utilities of various voltage levels (480V, 240V, 208V, 3 phase, 60Hz and 120V, 1phase, 60Hz). Compressed air – 80 psi. House steam – 50 psi. Water for injection and pure steam available.