Supporting customers in creating, reviewing and upgrading documentation for a full compliant quality system. Ensure no Data Integrity problems.
Supporting investigations to identify root causes, proper corrective and preventive action and effective CAPA plan. Supporting customers to avoid repeat deviations and Out Of Specifications.
Unique Personal coaching to individuals and groups to build GMP habits. Need-based GMP training to improve the GMP culture in the company and to build employee confidence towards compliance.
Assess the Gap in Quality culture, practices and in regulatory requirements. Recommendation with action plan to bridge the gap to improve GMP CULTURE. Activity support for readiness of regulatory audit.
GMP assessment of national and international vendor of KSM, API, Excipient & Packing material across the world.
Vendor audits for Medical Devices – QMS
Support the Qualification and Validation activity for equipment/ instrument/ area/ cleanrooms/ controlled storage area as per requirement.
(Gap Assessment /Internal Audits/Vendor Audits including Medical devices-QMS). Readiness evaluation for GMP Regulatory audits.
e.g. Nitrosamines, Extractables & Leachable
(write, edit and upgrade GMP documents)
