Research & Development
Sheffield Pharmaceuticals offers an extensive selection of formulas developed by on-site R&D formulators. These professionals stay current with the latest technologies, product trends, and noteworthy ingredients to meet customer needs and develop unique formulations.
Operating within industry regulations, Sheffield’s R&D Team is capable of developing products from start to finish. From conception through product launch our team will provide the expertise and support needed to ensure that the customer is completely satisfied with our product development services by offering:
- Customized formula development and method of manufacture
- Reverse engineering of national brand products with third party confirmation
- Prototype sample preparation
- Denture Adhesive Cream development and evaluation
- Oral care and OTC consults
Sheffield Pharmaceuticals has in house Microbiology and Chemistry laboratories, which are responsible for incoming raw material and packaging inspection and testing and in process and release testing of bulk product and finished goods. All testing requirements are established to meet current regulations and customer needs. Quality Control is also responsible for the monitoring of our facility and the USP purified water system at our location.
Sheffield’s years of diverse experience in the pharmaceutical industry have come together to create a highly trained, highly motivated, Quality Control Organization that includes full service chemical and microbiological laboratories. Our GMP driven laboratories ensure that our finished products conform to USP, BP, EP, JP, FCC and equally important customer requirements. Certificates of Analysis and Product Specifications are available for all production batches. In-coming raw materials and packaging components undergo extensive testing and quality checks.
Chemical testing capabilities include but are not limited to UPLC, HPLC, GC, FTIR, Specific Ion Electrode, pH, Viscosity, Total Organic Carbon, and Adhesion testing.
Additional services provided are Process Evaluation/Validation, Packaging Validation, equipment IQ/OQ/PQ and Method Validation.
The Quality Assurance department is responsible for the confirmation that products produced at Sheffield Pharmaceuticals meet all FDA and customer requirements. This and compliance with FDA drug product and medical device regulations are achieved by Quality Assurance oversight and interaction throughout the facility. This includes educating, and promoting cGMP compliance as well as risk based management. The Quality Assurance Department performs, offers, and supports a wide range of cGMP and regulatory services, including:
- Annual Product Reviews
- Complaint File handling and investigation
- Document Control
- Artwork and label review
- Quality internal and external auditing
- Preparation of Quality Agreements
- Regulatory filings and submissions
Microbiological testing capabilities include but are not limited to microbial limit testing, specific organism testing, suitability testing, growth promotion, water testing, and environmental monitoring. Testing is developed to comply with current USP harmonization requirements. In addition to the standard testing the following specialty testing is also performed on site; cleaning validation, microbial identification, Microbial analysis as part of Stability protocols and antibiotic testing. The on-site stability program consisting of Accelerated, Intermediate and Controlled Room Temperature stability chambers are maintained according to ICH guidelines supporting a comprehensive in-house stability program.
Label Compliance System
Sheffield Pharmaceuticals has years and years of experience and training in the area of FDA compliant food and drug labeling rules, regulations and laws. One of our most valued added services as your contract manufacturer is the expertise that your current labels and/or new label will be afforded as it goes through our stringent label approval process. This process saves you the customer from costly and damaging legal and safety claims issues with regulatory agencies.
Label Compliance Features
Our team of regulatory specialists are available to:
• Review formulations to ensure compliance with ingredient restrictions, OTC monographs, EU Directives, and Canadian Regulations.
• Provide compliant ingredient labeling for cosmetics and Drug Facts for OTC drugs.
• Final artwork review to ensure compliance.
• Screen formulations for California Safe Cosmetics Act reporting requirements.
• Ensure product compliance with California Environmental Protection Agency Air Resources Board Consumer Products Regulations.
• Review and validate safety testing for each product.
• Verify OTC products are tested according to monograph requirements where applicable.
• Prepare reports on request.
• Complete FDA Voluntary Cosmetic Product Registration on request.
• California Prop 65 compliance.
Clear communication and transparency are key to Sheffield Pharmaceuticals and its relationship with its customers. To help ensure clear expectations between our customer and ourselves we recommend the implementation of quality agreements so that roles and responsibilities are met and understood by both parties. We also will provide the appropriate documentation as needed to satisfy regulatory audits and internal requirements of our customers.
Method Development, Validation, and Method Transfer
Among the analytical services we provide, Sheffield Pharmaceuticals has the expertise and experience in Method Development and Validation.
Master Validation Plan
Sheffield Pharmaceuticals has a master validation plan that encompasses the introduction of new or modified equipment qualification, Computer System Validation, Full Scale Process Validation and Cleaning Validation. Validations are created and executed in a manner consistent with compliance regulations and guidance’s.