REGULATORY COMPLIANCE SUPPORT

WHO – Exports

Checklist for WHO

We can provide our services for getting the WHO certification and these services will be as per the following:

• Layouts finalization for man/ material/ scrap, DP, EMERGENCY exit, AHU, Classification, drain, Fire alarms etc. and Evaluation of site readiness to meet WHO requirements.
• Finalization of the Quality manual, quality policy and Other documentation as per regulatory requirement.
• Gap Assessment of the utilities, facility, equipment and processes etc and there remediation of the same if required.
• Review and execution as per Preparation (If Applicable) of qualification Protocols like URS,DQ,IQ,OQ,PQ Facility Qualification etc. against WHO requirements.
• Process SOPs finalization and gap assessment.
• Self-inspection, Quality management Review, Product recall and mock recall review and other key SOP’s review/ GAP assessment and  updation as well as execution at site.
• Review of QC / Microbiology related practices and procedures, gap assessment and execution.
• Review of ware housing practices/ material flow and storage as per the material requirement as per regulatory requirements.
• Identification of the SMEs from each department and placing the right person at right place.
• To impart training to the task force inclusive of senior management on cGMP requirements on all the KEY topics etc.
• Review of safety systems of site w.r.to the personnel and product.
• Stability summary of Applied products.

Checklist for GMP