GMP Facility Setup Consultation

Introduction

Ensuring Compliance & Operational Excellence

Setting up a Good Manufacturing Practice (GMP) facility is a crucial step for companies in the pharmaceutical, nutraceutical, veterinary, and cosmetic industries. A well-designed GMP-compliant facility ensures product quality, regulatory compliance, and operational efficiency.

At Victory Pharma Consultancy, we provide comprehensive GMP facility consultation services, guiding businesses through the design, setup, and compliance process to meet local and international regulatory standards.

GMP Facility Setup Consultation

Why Is GMP Compliance Essential?

GMP compliance ensures that products are consistently manufactured and controlled according to quality standards. Regulatory bodies such as the National Pharmaceutical Regulatory Agency (NPRA), World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and the U.S. FDA mandate strict GMP guidelines.

Non-compliance can lead to production halts, legal penalties, and product recalls, making it critical to establish a fully compliant facility from the outset.

GMP Facility Setup Consultation

Our GMP Facility Setup Services

Facility Design & Layout Planning
  • Conceptualization of GMP-compliant facility designs
  • Cleanroom classification and environmental control planning
  • Optimized workflow design to prevent cross-contamination
Regulatory & Compliance Consultation
  • Assistance with GMP certification applications
  • Guidance on NPRA, PIC/S, WHO, and FDA compliance requirements
  • Development of Standard Operating Procedures (SOPs)
Equipment Selection & Validation
  • Selection of GMP-compliant machinery Installation Qualification (IQ), Operational
  • Qualification (OQ), and Performance Qualification (PQ)
  • Equipment calibration and validation support
Documentation & Quality Management Systems (QMS)
  • Preparation of GMP documentation (SOPs, Master Batch Records, Validation Reports, etc.)
  • Implementation of Good Documentation Practices (GDP)
  • Establishing corrective and preventive action (CAPA) plans
Personnel Training & Audits
  • GMP compliance training for facility staff
  • Internal audits and pre-inspection readiness assessments
  • Mock regulatory inspections to ensure preparedness
GMP Facility Setup Consultation

Who Needs Our Services?

If you are a foreign company, you must comply with Malaysia’s NPRA and other regulatory bodies. Victory Pharma Consultancy serves as your local expert to ensure a seamless facility setup.

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Victory Pharma Consultancy

Contact With Us!

G.016, THE SQUARE, JAYA ONE, 72A, Jln Profesor Diraja Ungku Aziz, Seksyen 13, 46200 Petaling Jaya, Selangor

Call us: +60 16-213 4487

Mon – Sat: 8.00am – 18.00pm / Holiday : Closed