Quality System Management - Audits
We offer Extensive coverage
- Sterile dosage forms
- Oral solid dosage
- Liquid dosage forms
- Topical dosage forms
Agency Audits Faced
IBPS offers support to its clients for conducting periodic cGMP audits, due diligence audits, for-cause at their own sites and at their contract manufacturing sites. IBPS team has rich, hands on experience of working with various dosage forms like oral solid dosages, oral liquid dosages, sterile preparations, topical and external preparations. We also have extensive experience on aseptic processes, QC and Microbiology, APIs, biologics and devices.
We offer an unbiased audit, quick turnaround in terms of providing the audit observations and report, efficient communication between the client and the sites and where required, IBPS (on request) also provides remediation support to the client / client sites.
REMOTE AUDIT IN COVID TIMES
Amidst COVID pandemic and travel restrictions, performing audits was a major hurdle which was overcome by IBPS by conducting successful remote mock FDA inspections, led by a team of quality experts, including ex-USFDA inspectors which enabled the client to execute the program on the desired timelines that culminated in filing an IND for the US market successfully.