AUDITS: Independent Supplier Audit: (GMP System and Facility Audit)
AUDITS: Independent Supplier Audit: (GMP System and Facility Audit)
| To evaluate the system and manufacturing facility in compliance with 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)
- Organizations
- Equipment control
- Personal
- Quality policy and Quality Management Systems
- Environment control
- Material/Component Control
- Operational Control
- Finished Product control
- Good Documentation practice
- Good manufacturing practice
- Inspection history
- Computer system validation
- Data Integrity approach
- Vendor qualification/assessment Audit
To evaluate and qualify the vendors for procurement of critical supplies like API, excipients, packaging material, contract manufacturer, materials & Goods etc. This vendor qualification audit ensures the vendor’s reliability and quality services/products to avoid any regularity concerns. The main objectives of a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes. We have a robust team for such audits to provide your company with a means to verify that third-party vendors meet the applicable FDA laws and regulations.
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
Remote Audit / Virtual Audit
At MPC, 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 traveling and this makes the on-site audit difficult. With the acceptance of Remote audits by various regulatory agencies, many of our clients have suggested performing remote audit / Virtual audits. MPC 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.
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
GAP Audit
Gap analysis relates either to the entire GMP system or to individual subareas and is an active comparison of the established current state with the requirements specified by local or international GMP regulations.
MPC has successfully carried out many of such gap analyses and offers this consulting service for all GMP systems. If you are in the process of preparing for an internal, external or upcoming regulatory inspection, we can support you with full commitment and professional expertise by our trained and experienced consultants.
The consultant generally first checks the company-specific documentation and creates a gap analysis plan. Based on the gap analysis plan, the consultant conducts the analysis on-site. All document deficiencies and gaps identified on site are listed separately in the analysis report. The consultant supplements the deficiencies listed in the final report with proposals for appropriate corrective actions and with addressed associated regulations.
QMS Audit
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001
- MPC has ASQ certified quality auditor
- MPC is providing Market Authorization in UK and EU
- MPC is supporting in QP process and product Approval in UK and EU region
- MPC is supporting in Consolidation investigation, Audit response, and remediation process.