Today, Crystal Pharmatech announced that the GMP manufacturing facility of their CDMO business unit – Crystal Formulation Services (CFS) has successfully passed a remote audit conducted by a US client. The audit, which lasted for four days, confirmed that CFS's infrastructure, quality systems, and verification and validation procedures are in compliance with international cGMP standards, laying a solid foundation for the company to provide CDMO services that meets the regulations of the FDA, NMPA, and EMA.
The audit was focused to confirm that the GMP manufacturing facility of CFS meets the US GMP regulations, and to ensure the compliance in manufacturing and testing of drugs to be used in clinical trials in the USA. The scope of the audit included quality management systems, material and sample management, facilities and equipment, pollution and cross-contamination prevention and control, deviation/OOS investigation, change control, supplier management, training, confirmation and validation, data integrity and risk assessment.
During the audit process, experienced auditors thoroughly evaluated CFS's established quality systems, GMP facilities, manufacturing and packaging facilities, warehouse, processes, and documentation system through reviewing the various documents, online real-time meetings, Q&A sessions with staff, technical discussions, etc. Crystal Formulation Services comprehensively, accurately and timely manner showcased that its high-standard equipment and QC facilities met the customer's expectations in all aspects because of its thorough system and standardized procedures. After the completion of the extensive remote audit through smooth communication, the auditor complimented CFS positively.
"This successful remote audit is a key milestone for CFS, as we continue to expand our high-quality CDMO services globally," said Dr. Decheng Ma, CEO of Crystal Formulation Services. "It demonstrates that the GMP system we have built over the past year has gained recognition from our international clients. We will continue to work hard to further enhance our company's quality management level and lay a solid foundation for CFS's future, and fulfill our mission of providing high-quality oral formulation development and manufacturing services for global innovative drugs, accelerating their market launch, and enabling patients to use high-quality drugs as soon as possible."
Dr. Alex Chen, Chairman and CEO of Crystal Pharmatech, said, "This successful remote audit by our US client marks that Crystal Pharmatech is capable of producing and delivering products and clinical trial samples that comply with US GMP regulations. Crystal Pharmatech and its subsidiary Crystal Formulation Services will continue to embrace our cultural values of "perfection" and "exceeding", focusing on customer demands, and rely on a complete quality system and fast delivery to continuously provide customers with the optimal form, formulation and process. We will work together with clients to help develop and launch more innovative and effective drugs in coming future.