Quality and Compliance at Virat Infusions – Virat Infusions | Injectable Manufacturing Project in India
Ujjain, Madhya Pradesh, India +91 734 2500000 enquiry@viratinfusions.com
Greenfield Injectable Project
Business Enquiry
Quality & Compliance

Quality Built Into the Project From the Beginning

At Virat Infusions, quality is being built into the project from the beginning. A greenfield facility creates the opportunity to define systems, responsibilities, qualification plans and operating disciplines before commercial manufacture starts. Our objective is to develop a quality management system suited to sterile products and the markets we intend to serve.

Quality Architecture

Core Quality Systems in Development

The pharmaceutical quality system (PQS) is being established in accordance with cGMP standards, defining governance from civil construction through to commercial release:

Pharmaceutical Quality System (PQS)
Comprehensive quality governance incorporating rigorous document control, change management, deviation handling, root-cause investigations, CAPA tracking, Quality Risk Management (ICH Q9) and periodic management reviews.
Qualification (DQ / IQ / OQ / PQ)
Four-stage qualification lifecycle for cleanrooms, utilities (WFI, pure steam, clean air) and manufacturing machinery, ensuring documented proof that equipment is installed correctly and operates within established tolerances.
Process Validation Lifecycle
Three-stage validation approach encompassing Process Design (Stage 1), Process Qualification (Stage 2: commercial batches and media fills), and Continued Process Verification (Stage 3: ongoing parameter monitoring).
Sterility Assurance & Contamination Control
Contamination Control Strategy (CCS) governing gowning protocols, cleanroom disciplines, environmental monitoring (viable and non-viable particulate count), laminar air flow velocities, and isolator barriers.
Cleaning & Sterilisation Validation
Validated automated Clean-in-Place (CIP) and Sterilise-in-Place (SIP) cycles, maximum campaign hold times, disinfectant rotation studies, and lethal heat distribution verification across terminal sterilisation autoclaves.
Data Integrity (ALCOA+)
Zero-tolerance governance for reliable, Attributable, Legible, Contemporaneous, Original, and Accurate records across all electronic analytical instruments, audit trails, and physical production logs.
Laboratory Controls & Analytical Release
Full spectrum chemical, physical, and microbiological laboratory controls with validated test methods for raw materials, in-process samples, finished parenterals, container closures, and stability monitoring.
Supplier Quality Management
Rigorous vendor qualification program for Active Pharmaceutical Ingredients (APIs), primary containers (glass, non-PVC films), and sterile excipients, backed by periodic supplier audits and quality agreements.
Progression Framework

Greenfield Quality Validation Programme

The qualification and quality assurance programme is deployed systematically across key development stages:

Stage 1

Design Review & Risk Assessment

Cleanroom layout reviews, differential pressure mapping, and Failure Mode and Effects Analysis (FMEA).

Stage 2

Facility & Equipment Qualification

Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and IQ/OQ protocols across utilities and lines.

Stage 3

Laboratory Readiness & Transfer

Analytical equipment calibration, compendial method verification, and microbiology lab commissioning.

Stage 4

Process & Cleaning Validation

Cleaning validation protocols, CIP/SIP verification, terminal autoclave load profiling, and hold-time studies.

Stage 5

Media Fills & Aseptic Simulation

Comprehensive microbiological growth medium simulations to validate aseptic filling line integrity.

Stage 6

Licensing & Ongoing Verification

Regulatory inspection readiness, formal licencing, stability studies, and Continued Process Verification (CPV).

Regulatory Compliance Policy

Approvals and Certifications Roadmap

During the construction and commissioning phases, Virat Infusions strictly maintains an honest, factual public record. We do not publish speculative compliance badges or unverified regulatory marks.

Official Notice

Regulatory Approvals Status

Virat Infusions is developing its facility, quality systems and validation programme for sterile injectable manufacturing. Regulatory approvals and product licences will be added to this website as they are formally obtained following statutory inspection and validation.

Audit & Quality Discussion: Prospective contract-manufacturing clients, institutional procurement teams, and export partners are welcome to review quality documentation, line qualification plans, and validation milestones under a mutual confidentiality agreement.