Quality

Quality

Quality Built Into Every Process

At Bhakra Pharmaceutical, quality extends beyond final-product testing. It begins with incoming materials and continues through manufacturing, in-process controls, analytical testing, microbiological evaluation, documentation and finished-product release.

Our Quality Philosophy

Control. Consistency. Compliance.

Our quality systems are designed to support disciplined pharmaceutical manufacturing through defined processes, appropriate documentation, laboratory evaluation and independent quality oversight.
The organizational structure includes dedicated QA and QC teams under the Quality Head, separate from manufacturing operations.
Quality Control Laboratory

Analytical Capabilities Supporting Product Quality

Bhakra Pharmaceutical maintains a dedicated Quality Control laboratory equipped to support analytical evaluation across pharmaceutical manufacturing.

Key Equipment Includes:

  • FTIR – PerkinElmer Spectrum Two
  • Automatic Karl Fischer Titrator
  • pH Meter
  • Conductivity Meter
  • Moisture Analyzer
  • Digital Melting Point Apparatus
  • Refractometer
  • Friability Test Apparatus
  • Disintegration Test Apparatus
  • Hardness Test Apparatus
  • Tap Density Test Apparatus
  • Leak Test Apparatus
  • Polarimeter
  • HPLC – Waters Alliance e2695
  • Gas Chromatography (GC) – PerkinElmer Clarus 690
  • UV Spectrophotometer – Shimadzu UV-1900i Plus
Microbiology Laboratory

Dedicated Microbiological Control

The Microbiology facility supports controlled microbiological testing through dedicated equipment and controlled work areas.

Key Equipment Includes:

  • BOD Incubators
  • Horizontal Autoclave
  • Vertical Autoclave
  • Microbiological Safety Cabinet
  • Laminar Air Flow
  • Mobile LAF
  • Dynamic Pass Boxes
  • Water Bath
  • Colony Counter
  • Fogging Machine
  • Air Sampler
  • Microscope
  • pH Meter
  • Vortex Shaker
Dedicated Microbiological
Environmental & Air Control

Controlled Manufacturing Environments

The facility uses separate AHU systems across operational floors to support controlled manufacturing environments.

40AHUs TOTAL ACROSS
THREE OPERATIONAL FLOORS
10
AHUs

Ground Floor

21
AHUs

First Floor

9
AHUs

Second Floor

40
TOTAL AHUs

Systems include

01

Pre Filtration

02

Fine Filtration

03

Fresh Air Filtration

04

Cooling Coils

05

Blowers Fans

06

Supply Air Dampers

07

Return Air Dampers

08

Fresh Air Dampers

Pharmaceutical Water System

Purified Water Designed For
Controlled Pharmaceutical Operations

Bhakra Pharmaceutical's purified-water system is based on

01

Two-Pass Reverse Osmosis (RO)

→
02

Electrodeionization (EDI)

→
03

UV Disinfection

Generated purified water is stored in a 3,000-litre jacketed storage tank and continuously circulated through an SS 316L closed-loop distribution system serving 34 Points of Use.

21 CFR

Water-system controls designed with 21 CFR Part 11 considerations for electronic data integrity and traceability.

Quality Lifecycle

Quality At Every Stage

Pharmaceutical manufacturing and quality control
Quality Every Stage
01
01

Raw Material Assessment

02
02

Controlled Dispensing

03
03

Manufacturing

04
04

In-Process Quality Checks

05
05

Laboratory Evaluation

06
06

Packing & Inspection

07
07

Finished Product Evaluation

08
08

Release

Future Regulatory Readiness

Building for Global Regulatory Expectations

Bhakra Pharmaceutical's long-term quality strategy includes strengthening capabilities around

Analytical Method Validation

Process Validation

Stability Studies

CTD Documentation

BA/BE Studies

International Product Registration