Isha's GMP Consultancy, Chennai - 600 014, India
Monday - Saturday 08:00-19:00
+91 9976491578
Audit Services
Isha’s provides audit services and inspections process encompasses unique tools and techniques based on best practice guidelines and detailed background research. We ensure that our auditors have the ability from a commercial, technical and GMP point of view to identify genuine risk and potential risk. We have hands-on experience in Global GMP guideline from a wide range of regulatory authorities. GMP Compliance can offer guidance and practical support in the following areas:
- Site audits and qualification of API/Formulations manufacturers in compliance to ICH Q7, excipient manufacturers, contract manufacturers and suppliers, packaging and labeling contractors, warehouse contractors and contract laboratories.
- Site audits of finished products
- Pre-inspection approval assessments
- API/Formulation QP audits and certifications
- Auditing facilities to ensure an appropriate level of due diligence
- Pre-regulatory assessment audits and gap analysis
- Mock regulatory audits
- CMO fact finding inspections and investigative inspections
Our third-party audits meet the highest standards in quality and independence
We conduct manufacturing facility inspection and laboratory inspections. Audit reports / observations are sent within 15 days of the audit. Risk assessments are considered during the inspections. Necessary corrective and preventive actions are also mentioned in the inspection / audit reports. We perform techno commercial audits also to give an opinion for the Investments.
Benefits
- Time and money saved on audits
- Independent, high-quality verifications of GMP compliance of manufacturers
- Decreased workload for the qualified person
- Internationally recognized API audit reports
- Reduced number of audits for both Manufacturing Authorization Holders and API suppliers
Highest Quality
Our accredited third-party API audits meet the highest standards to ensure the highest quality, independence and acceptance by authorities worldwide. we coordinates the audits to be performed in a 4-way system in which the auditors are commercially independent of both the API supplier and the client. They will deliver the audit report regardless of the audit result.