Services

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.

Regulatory Support: Assistance with regulatory submissions, including electronic submissions.

Product Stability Testing: Stability testing throughout the product’s shelf life.

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 and established relationships with printed material vendors.

GMP Compliance/Audit Support: Provides on-site or paper audits of suppliers and service providers to help ensure eGMP compliance.

GMP Training: GMP training is required at the time of hire and continuing education occurs throughout the year. Hanford can provide the same training to your staff that our employees receive.

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.

Types of Products/Formulations Produced:

• Sterile Liquids
– Formulation and filling in vials

• Sterile Powders
– Formulation and filling in vials

• Non-formulated sterile powders
– Filling in vials

• Non-sterile intramammary mastitis products
– Formulation and filling in plastic syringes

• Non-sterile powder
– Formulation and filling in bottles

• Non-sterile, non-formulated powder
– Filling in pouches

• Various non-sterile liquid ointment and cream filling products

• Tablets
– Blending, drying, compression, packaging

The Company maintains a comprehensive process control department that reports to quality assurance. Process control undertakes the activities most often termed “process validation” in the pharmaceutical industry, but at Hanford, they play a role that is far broader than validation alone. Process Control manages all of the Company’s validation activities, including installation, operational, and process qualification of all equipment. Process Control also undertakes all protocol writing, the execution of validation studies, and final report writing. Many of these reports are used in Hanford’s submissions for regulatory approval of new products or improved processes.

Validation at Hanford is a multi-disciplinary activity, particularly in areas such as process simulation testing of aseptically-filled products and packaging, where employee performance is a critical component in process control and therefore product quality. It is generally recognized that the aseptic production of sterile products is the single most difficult production undertaking in the pharmaceutical industry. The regulatory requirements for demonstrating that an aseptic process is in a validated state of control are both rigorous and specific. The Company is required to comply with the same regulatory guidelines and to achieve the same demonstrated levels of performance as Fortune 100 multi-national pharmaceutical companies. For a relatively small company such as Hanford to fully comply with current industry best practices requires a process control discipline capable of operating at a very high level of efficiency.

In addition to validation, Process Control undertakes process improvement initiatives and engages in support of all new product development or line expansion. The scientists in Process Control are also proficient in risk analysis techniques that are so vital to both validation planning and problem resolution with the modern pharmaceutical quality system. Regulations require that each process undergo a periodic, usually annual, reassessment and retesting of process control status. This activity, often known as revalidation, is also the responsibility of Process Control, which maintains the specific written procedures that define the scope of this work.