GMP Audit Services
Below are the types of audit offered
1. Independent Supplier Audit: (GMP System and Facility Audit)
To evaluate the system and manufacturing facility in compliance to the regulatory expectation and quality standards. To ensure the capability of the facility to manufacture quality medicine. To determine the effectiveness of the Quality system implemented and adherence to the specified quality objectives.
Audit scope incudes (Not limited to),
- Equipment control
- Quality policy and Quality Management Systems
- Environment control
- Safety and security
- Material/Component Control
- Operational Control
- Finished Product control
- Good Documentation practice
- Good manufacturing practice
- Inspection history
- Computer system validation
- Data Integrity approach
- Business continuity plan
2. Remote Audit / Virtual Audit:
At Zenovel, we have been conducting Remote GMP Audits/ Virtual Audits of suppliers for our clients. In the global pandemic situation, there have been many restrictions on travelling and this makes the on-site audit difficult. With the acceptance of Remote Audit by various regulatory agencies, many of our clients have suggested performing remote audit / Virtual audit. Zenovel has well defined SOPs and systems to perform Remote Audits. So far, we have completed more than eighty Remote Audits on behalf of our clients.
3. GAP audit
Zenovel has been conducting GMP GAP audits for numerous Pharmaceutical Companies to assess their level of compliance with requirements of Desired Regulatory Agencies.
4. Regulatory compliance Audit
A compliance audit is done for a comprehensive review of an organization’s adherence to specific regulatory guidelines & specifications mentioned and to evaluate the strength and thoroughness of compliance preparedness. This audit also focuses on the QMS system and any loopholes to work on. Improves the Quality system and in turn compliance to regulatory.
5. Vendor qualification/assessment Audit
To evaluate and qualify the vendors for procurement of the critical supplies like API, excipients, packaging material, contract manufacturer, materials & Goods etc. This vendor qualification audit ensures the vendor reliability and quality services/products to avoid any regularity concerns.
Audit scope includes (Not limited to),
- Vendor qualification/requalification system
- Vendor Quality management system
- Capabilities to deliver consistence quality
- Supply chain management
- Operation control
- Regulatory adherence
- Business continuity plan and Quality policy
6. Pre-Inspection Audit
This Audit is mainly conducted before any planned or announced regulatory inspection of the facility. This audit covers the complete 360-degree assessment approach to get ready for the regulatory audit.