Our approach to sterile manufacturing fully supports cGMP compliance. To that end, we have developed a hierarchy of business priorities that always puts quality first. JHP has an experienced Quality Assurance organization that will provide the quality oversight needed for development work as well as commercial manufacturing. JHP has established quality systems for validation, change control, deviation management, batch release, and CAPA. The quality systems are audited by global regulatory agencies, contract customers, and the JHP Compliance department.
JHP utilizes the Documentum system for document management. The system is validated and 21 CFR Part 11-compliant. Documentum is used for the management of test procedures, material specifications, forms, stability protocols, and Standard Operating Procedures.
Our extensive manufacturing experience provides our partners with efficient product execution and reduced time to the commercial stage of production. Quality, a core principle at JHP, is never sacrificed at any point along the way. JHP offers a full complement of microbial and chemical testing services for raw materials, in-process and finished goods samples. All of our testing is detailed with Standard Operating Procedures and performed in accordance with USP/NF and EP methodologies and monographs in addition to any client-supplied methods. Testing services capabilities include but are not limited to endotoxin testing, bioburden, sterility, particulate, microbial limits, pH, TOC, GC, HPLC, Karl Fischer, UV Vis, AA, and various wet chemistry tests. All laboratory instrumentation that utilizes software to collect and analyze data (e.g. chromatography data system) has been validated and is compliant with 21 CFR Part 11.