Background

Set on over 13 acres, NAAFCO Pharma Ltd started production of human medicines in 2015 with a cGMP manufacturing facility. The production range encompasses tablets, capsules, pellets and liquids in the form of suspension and solutions. The next phase will incorporate injectable and cephalosporin. It has raw material, production and finished goods buildings of 28k sft each in separate prefab single storey structures. The raw material storage facility has temperature control with humidity sensors, several cold rooms and class-maintained dispensing and sourcing areas, all racked. The finished goods area has similar arrangements. The production, packaging and storage areas are covered by HVAC system of 16 AHUs & central air conditioning, as well as European sourced water generation unit of 1 kL/hr with Loop system. The facility is underpinned by QA, QC, PD with R&D and Microbiology lab equipped with the latest in high specification analysis machinery. For a visual tour of our facilities please visit the YouTube

MISSION & VISION

For pharmaceutical products, the most modern production and compliant facility is crucial in ensuring excellent products. The quality of the plant and equipment must be matched by the quality of personnel involved. NAAFCO Group has grown and thrived entirely by guaranteeing quality products and services in all of its business endeavors. NAAFCO Pharma continues this commitment to quality by investing in the latest up-to-date plant and machineries as well as headhunting the best. Thus we have the production of best quality products, by best quality people at the best value.

Bangladesh has just stepped onto the upward curve of rapid development and as such with an increasing wealthier population with access to medical care; the demand for both quantity and quality of medical products will increase lockstep with the nation’s growth. The 1982 Drugs Act has left a legacy of strong robust champion pharma companies within a well regulated industry. NAAFCO Pharma will take its place amongst these companies both in domestic and international markets.

KEY MILESTONES
OUR PEOPLE

NAAFCO Pharma has selectively headhunted key personnel from the industry based on fitting expertise and experience. Bangladesh has a well-established and stable pharmaceutical industry.

FACILITIES
SUMMARY

  • Total site area : 20 acres (of which 5 acres has been developed)
  • Production : 28,000 sq ft
  • Laboratory : 9,000 sq ft (qa, qc, microbiology, pd)
  • Warehouse : 56,000 sq ft (raw & finished goods)
  • Animal Medicine : 8,000 sq ft
  • Others : 13,000 sq ft (admin, canteen, training, dorms)
  • Total covered : 114,000 sq ft

This facility has been custom designed and built to meet pharmaceutical requirements (cGMP-WHO) in terms of design, materials of construction, HVAC, and utilities that includes purified water, drains, electrical and lighting systems.

Production Capacities (Current)
Human Medicine

*depending on tablet sizes 60-1,800mg

  • 4 liquid filling lines
  • 6 solid dosage filling lines
  • additional liquid and solid capacities to be added by March 2017
Animal Medicine
Production Area

NAAFCO Pharma’s manufacturing facility is GMP compliant and has an experienced skilled workforce. The most modern and advanced manufacturing equipment are utilized throughout all stages of production. NAAFCO Pharma’s manufacturing area is classified Class D (100,000) Cleanroom standard. The injection manufacturing has all relevant cleanroom standard (Class A,B, C,& D).

Material Storage and Warehousing
Adequate temperature controlled raw material warehouse space 28,000 sft with cold room (2-8C), cool room (8-15C), control room (25c> & rh 60%>) has been made available to handle incoming raw and packaging material, in-process stocks as well as separate storage of finished products, temperature mapped under 30C, conforming to ICH guidelines. Warehouse access is restricted to designated personnel, and the flow of materials follow SOP-set procedures throughout raw material sampling, quarantine, release, issuance to production and finished product storage. The finished good warehouse is also of 28,000 sft. Full racking system for both warehouses is also available.
Cleaning and Sanitation
Manufacturing and packaging areas and equipment are cleaned according to approved cleaning procedures, as per CIP & SIP. Concentration of cleaning agents and frequency of use are determined by applicable validation studies.

EQUIPMENT LIST
HUMAN MEDICINE
  • Rapid Mass Mixer Granulators (RMG)
  • Fluid Bed Dryers
  • Coating machines
  • Cold Forming Blister machines
  • Hot Forming Blister machines
  • Strip Packing machines
  • Tablet Counting, Filling-Cap sealing & Labeling machine
  • Hard Shell Encapsulation Machines
  • Double Cone Blenders
  • Sachet Packing Machin
PRODUCT DEVELOPMENT
  • Fluid Bed Dryer
  • Double Cone Blender
  • Multimill
  • Rapid Mixer Granulator
  • High Speed Auto Coating Machine
  • Mixing tank with tilting function
  • High shear homogenizer
  • Jacket tank
  • Tablet Compression Machine
  • Blister Packing Machine
ANIMAL MEDICINE
  • High Speed Mixer Granulator (RMG) Fluid Bed Dryer
  • Multimill
  • Sifter Machine - sieving
  • Double Cone Blender
  • Tablet Compression Machine
  • Blister Packaging Machine
  • Auto Sachet Sealing Machine, Horizontal
QUALITY MANAGEMENT
GMP Compliance

Naafco Pharma maintains a QMS in alignment with the requirements of GMP, encompassing:

  • Quality Management
  • Personnel
  • Premises and Equipment
  • Documentation
  • Production
  • Quality Control and Assurance
  • Contract Manufacture and Analysis (where applicable)
  • Complaints and Product Recall
  • Self-Inspection
Core Elements
  • Change Control
  • Document and Records Management
  • Training
  • Product Quality Review
  • Quality Risk Management
  • Equipment Qualification and Validation
  • Process and Cleaning Validation
  • Analytical Method Validation
  • Stability
  • Sampling and Analysis
  • Management of Retention Samples
QUALITY CONTROL
Chemical Testing

The laboratory contains the latest testing equipment needed for the verification of chemical compounds in raw materials and finished products. Much of the analyses involved include the use of equipment such as:

  • AAS (Atomic Absorption Spectrometer)
  • HPLC (Ultra High Pressure Liquid Chromatography)
  • TOC (Total Organic Count)
  • GC (Gas Chromatograph)
  • FTIR (Fourier Transform Infrared Spectrophotometry)
  • UV/Vis (Ultraviolet/Visible Spectrophotometry)
  • Dissolution and Disintegration testing
  • Titrimetric and Potentiometric assays;
  • Moisture, Friability and Hardness Testing
  • Stability and Photostability Study/Testing
MICROBIOLOGICAL TESTING

NAAFCO Pharma’s standard practice is to do microbiological testing on all raw materials and finished products to the current BP/USP standards. The microbiology laboratory is segregated within the main manufacturing facility. Its primary function is to verify the absence of harmful bacterial and other microbial contamination. Assays that are typically performed include:

Total Bacterial Count; Total Yeast and Mold Counts; and Testing for and identification of: Staphylococcus aureus, Escherichia coli, Pseudomonas, anaerobic bacteria, Clostridium perfringens and Clostridium species

ENVIRONMENTAL PROTECTION

NAAFCO is committed to balancing economical, ecological and social issues, in order to achieve and guarantee long-term development. Such development depends heavily on maintaining long-term environmental protection and sustainable resources. Ensuring the stability of the natural environment is a key priority of NAAFCO.

NAAFCO Pharma follows the Government's philosophy of sustainable development; therefore the company is keen on maintaining minimum impact on the environment.

CONTRACT MANUFACTURING

Boasting a state-of-the-art, highly equipped and large scale manufacturing facility with international standards, NAAFCO Pharma additionally facilitates contract manufacturing for any pharmaceutical products as per clients need. We have been serving some of the top 10 pharmaceutical companies in Bangladesh (Square, Renata among others) for their contract manufacturing requirements. NAAFCO Pharma is currently actively seeking new partnerships whether local or international. Having 4 liquid filling lines and 6 solid dosage filling lines allows much versatility and flexibility in size of production runs.