GMP Plant Setup and Upgradation

Zenovel has been the most credible pattern for GMP Audit Service. Good Manufacturing Practice Audits (GMP audits) are conducted to ensure that products are made in accordance with quality standards and the best industry practices. It is to identify if the pharma company has full control over your processes, facility and quality management system (QMS).

PLANT SETUP

PLANT UPGRADATION

If you already have the API or Formulation Plant which is approved by the local regulatory authority and if you want to expand your reach to regulated territories like USFDA, EMEA, WHO, MHRA, PIC/S etc then you May opt for Plant Upgradation Service,

Plant Upgradation Includes following,

Establishment of Proper scope for which regulatory is being targeted.
GAP Audit of Existing Plant (API/Formulation)
Preparation of GAP Audit Report,
Preparation of CAPA Plan,
Identification of GAPS and making time bound milestones for upgradation
Validation

Changes in Layout and design in required.
SOP and Procedures upgradation,
Policies redesign
Training
QMS system establishment/ restructuring as per requirement
Internal Audit System development

GCP

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

GCP

GMP

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

RA Services

AI-powered Regulatory Affairs Services

Pre Submission Service

Dossiers Related Services

Submission Services

Post Submission Services

Batch Release & Testing Services

Support & Staffing Services

RA Services

AI-powered Regulatory Affairs Services

Drug Dev. & Discovery

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

Key Expert Services

Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance