AUDITING (cGMP, GLP, USFDA, WHO)
To ensure that our customer's facilities are compliant with industry standards and in line with regulatory expectations, we can offer services in the following areas:
- Inspection readiness
- GMP Training
- Aseptic/Sterile Environments
- APIs
- Records Storage/Archive Facilities
- Contract Laboratories
- Internal Audits
- Supplier Qualification
- Quality Systems (CAPA, Complaint Management)
- Materials System (Materials Management and Controls, Sampling Requirements/Specifications)
- Production System (Process validation, Cleaning validation, Batch record issuance)
- Facilities and Equipment
Our GLP team has the experience and capability to conduct audits of all types including facilities; process data; study specific data and reports against GLP requirements. We audit central laboratories and bio-analytical laboratories for routine and specialised analyses against both GLP and GCP regulations.
- GLP audits of facilities, studies and reports
- Assessment of laboratories for compliance with GLP regulations
- GCLP audits of central laboratories handling human samples only
- Audits of bio analytical laboratory facilities to GLP and GCLP
- Training of clinical staff in the requirements of GLP and GCLP
Our Audit Team capable to conduct audits for facilities complying to USFDA, WHO, FDA etc and are categorized below:
- Routine Audits
- For Cause Audits
- Vendor Qualification Audits
- Validation Audits
- Inspection Readiness Audits
- Due Diligence Audits