GMP audits:
We conduct GMP audits as per the latest guidelines of USFDA, ICH, EU, PIC/S, WHO, Schedule M etc. for units involved in manufacturing of API, finished formulation, cosmetics etc. We also conduct vendor audits for our clients. The reports prepared are detailed, covering all the aspects with facts and specimens. The inspection is followed by compliance verification both on site and off site.
GLP audits:
We conduct GLP audits to ascertain the testing facilities and capabilities available with certain laboratories. The inspection involves verification and assessment of infrastructure, GDP, validations, practices and data integrity.
Facility Feasibility Audits:
We conduct feasibility audit on behalf of our client to assess the intended partner manufacturing sites. The audit helps the client to take informed decision whether to get into an agreement with the proposed site or not.
GAP assessment audits:
GAP assessment audits help our clients to have a clear and in-depth review regarding the lacunas or GAPS present in their existing system. GAPS may be present w.r.t. infrastructure, QMS, trainings etc. The GAP assessment is followed by CAPA.
