“QUALITY PRODUCT FOR BETTER HEALTHCARE”

The priority of the department is to ensure the quality of the product manufactured at Amtech Med (P) Ltd for better Healthcare of the Nation.

Quality Control Department (QCD)

Significant steps have been taken to assure the quality of products. These steps include advanced training of personnel, procurement of state of the art inspecting and analytical equipments and modernization of the quality control area.
Department is independent of all other departments. The Quality Control Department controls all Raw materials, Bulk Product, intermediate product, finished Product, stability, Packing material, water and microbiology. QCD has been designed to suit the operations to be carried out in them. The environmental condition of the laboratory is maintained to meet the analytical requirements. QC department is well equipped with many of the advance instruments.

RESEARCH AND DEVELOPMENT (R&D)

We have continued focus in formulation development. We are increasingly working on more complex and specialized areas to develop medicines to heal the world. Amtech has been investing munificently on research and development.
Amtech believes that R&D holds the key of future success and sustainability of the industry is only possible through continuous quest for formulation innovations. For these very reasons, Amtech Med (P) Ltd has recently established technologically well equipped Formulation, Research & Development (FR&D) center. The FR&D lab consists of R&D model FBD, Mass mixer, Sifter, ICH Standard Stability Chamber, Turbo Stirrers, etc for formulations development.
Developed formulations are scaled up in controlled environment before the company launches commercial batches into the market.

Quality Assurance Department (QAD)

AMTECH strives to achieve quality of the products and services. Its quality assurance department ensures that quality; safety and efficacy are designed and built into our products. QAD is fully self reliant department with qualified, dedicated and experienced pharmacists to ensure that all the functions of Quality Control Department (QCD), Production Department, Store and House Keeping are well controlled.

Function

Set up procedures for implementation of WHO-GMP

Evaluating and approval of all validation protocols.

Audit and approval of vendors

Evaluating analyzing market complaints and batch Recall.

Routine finished product stability.

Assure regulatory and company standards.

Release or Rejects finished products.

Supervise change control system

Perform self inspection and GMP training.

Evaluation and approval of all final SOPS.

Review and approval of all master Processing procedures, master packing procedures and master analytical procedures.

Review and approval of all Batch processing Record prior to release of goods for distribution to ensure compliance to GMP during manufacturing of any batch.

Approval of final product specification.

Production Department

Manufacturing is carried out as per national and international drug rules and regulations using technologically advanced machines and equipments.
Manufacturing and quality excellence have been a thrust area at AMTECH MED (P) LTD. AMTECH operations started from manufacturing facility that was setup in 2005 at Katahari-4, Morang, Nepal. And over the last 14 years, AMTECH has setup for the manufacturing of its own brands. All of the AMTECH facilities are WHO-GMP certified for systems, and have the following dosage forms.

Block-I : Solid oral dosage forms: Tablets & Capsules
Block-II : External or Topical dosage forms: Ointments & Creams

Block-I : Liquid orals
Block-II

Solid oral dosage forms: Cephalosporin Tablets & Dry Syrup Some of the salient features of the design of the manufacturing facilities are as follows

The manufacturing facilities are in separate blocks.
Segregation of every critical processing activity in each zone to avoid cross contamination.
No wood or asbestos used.
Each processing area has separate AHU’s.
Each processing area conforming room air change, pressure, flow direction & particle count.
RO system, online monitoring of pH, conductivity. The plants are equipped with high speed machine and integrated packaging lines from the best manufacturers in India & Nepal for the cost effectiveness like multi station tablet press, high speed liquid & Dry Syrup filling lines as well as capsules, creams and lotions are some of the examples.