Department

Quality Control Department (QCD)

Multidisciplinary Liaison of knowledge, experience and dedication between the departments, within the organization, strives to achieve the activities, performance of regulation of regulatory guidelines under the governance of Quality Assurance department.
Amtech assures the quality to the efficacy and safety designed into its product and services by the implementation of regulatory norms for the manufacturing activity.

RESEARCH AND DEVELOPMENT (R&D)

We have separate, self contained and dedicated block for formulation and development of both human & veterinary products in total 2800 sq. ft area with separate 3 nos. of AHU and VRF system (Chiller) to maintain the clean room of class 100,000. Formulation, Research Department consists of R&D model FBD, Mass mixer, Lab model Tablet Punching machine, Coating machine, Sifter, walk in type Stability Chamber of ICH Standard, Turbo Stirrers etc for formulation development.
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 F, R&D holds the key of future success and sustainability of the industry which is only possible through continuous quest for formulation innovations. Developed formulations are scaled up in controlled manufacturing facility before the company launches commercial batches into the market.

Quality Assurance Department (QAD)

AMTECH strives to achieve quality of the products and services.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, Eng.& Mentance department 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 and handling market complaints and Batch Recall.

Monitoring of finished product stability.

Assure regulatory and company standards.

Release or Rejects finished products.

Aprove 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 Packaging Procedures and Master Analytical Procedures.

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

Approval of finished product specification.