Quality System and Engineering Services

Quality System Overview

Our Quality Management System meets the requirements of the Code of Federal Regulations (21 CFR, Parts 210 and 211)

Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General; Current Good Manufacturing Practice for Finished Pharmaceuticals and ISO 9001:2015 Standard.

Our Quality Manual is the top tier of our documentation system.

Tier 2 is company’s Standard Operating Procedures (SOP’s).

Tier 3 are the developed manufacturing documents, forms and specifications.

Quality Objectives
  • Meet the Client’s requirements for all products supplied;
  • Meet planned work schedules and customer delivery dates;
  • Employ and effectively train sufficient personnel to meet business demands;
  • Maintain an effective management and quality system in the form of an ISO 9001:2015 Quality Management System;
  • Satisfy and enlarge its Client base, and through this to enhance its long term profitability by supplying its high quality products, which consistently conform to the specified requirements of its Clients