Excellent Compliance Track Record – The compliance track record at our facility in Cincinnati, Ohio, USA is excellent, demonstrated by numerous successful inspections by FDA and by our customers.
Following our registration with FDA as API supplier [for both oligonucleotides and small molecules], Girindus received in 2007 and 2010 unannounced systems audits by the FDA that included small molecule and oligonucleotide manufacturing areas. The result of these audits were excemplary: no form 483 and no objectionable findings.
As a manufacturer for the life science industry, Girindus is fully committed to the current Good Manufacturing Practices (cGMP) for Active Pharmaceutical Ingredients as defined in ICH Q7. Our Quality Policy and quality systems incorporate the principles defined in ICH Q7 along with national and International regulations to ensure sustainable compliance in the US, European and Asian regions.
Our Quality Assurance/Regulatory Affairs team has over 50 years of cumulative experience, with a proven compliance record in the pharmaceutical industry and can provide regulatory support for the Chemistry, Manufacturing and Controls (CMC) Section for US and International regulatory submissions (DMF, IND, CTA, NDA).
Quality Assurance Capabilities
- Batch Records
- Certificate of cGMP compliance
- Deviation Investigations
- Audits – internal, external, client and FDA inspections
- Corrective and Preventive Action Program
- GMP Training
- Change Control
- Supplier Approval
- Validation and Qualification Program
Regulatory Affairs Capabilities
- Drug Establishment Registration (US FDA)
- CMC narratives for US and European Submissions
- Interaction with regulatory authorities