Quality Standards

Successful integration of Global Quality Standards at each phase of product development life cycle is a pre-requisite at Kiama and a constant priority. Meticulous assessment of applicable requirements combined with a proactive approach to implementing quality and regulatory standards are proven aspects for a successful project at Kiama.

Global regulatory and quality standards have been used while designing the quality systems and compliance standards at Kiama. The quality standards are harmonized across all Kiama’s departments and governed by Corporate QA policies.

The quality systems are continuously monitored and reviewed, with the involvement of Senior Management, to identify areas for improvement.

Quality Control

Quality Control establishes procedures for quality control of incoming materials, in the process, intermediates, API and Drug Products. The state of the art quality control laboratories follow all the current guidelines for monitoring the strict quality of our products / analytical services.

Quality Assurance

Quality Assurance is responsible for implementing and monitoring of Quality Systems throughout the company. Quality Assurance ensures the continued compliance with GMP and regulatory requirements. Quality Assurance controls all the operations starting from raw materials to shipping of products.

Regulatory Affairs

National and International Regulatory Affairs is responsible for filing all regulatory documents to various regulatory authorities as per the requirement of the clients and addressing all regulatory queries from clients & authorities.

Global Harmonization System

Compliance with applicable global standards is a core element of Kiama'S world-class quality systems. All of our product labels and Safety Data Sheets are compliant with the Global Harmonization System (GHS) of Classification and Labeling of Chemicals.

Labeling & MSDS

GHS creates common classification standards and communication protocols for chemical product labels and material Safety Data Sheets (SDS). It standardizes these important hazard communications so customers – regardless of their locations – can easily identify hazard information related to chemical products.

Packaging

All packaging shares a common design approach: containers crafted to match specific use, cost and operational requirements. This includes fully integrated, state-of-the-art chemical delivery platforms such as our Aluminum Bottle, Glass Bottle, HDPE Carboy, HDPE Drum for our product delivery systems.

Quality and Service

We are regularly inspected by The Food and Drug Administration FDA. We have also been Audited by a number of pharmaceutical companies.

This manufacturing facility was audited in the month of Jun 2020 for good manufacturing practices of API and Received Indian GMP complies

We have extensive experience in process development, analytical method validation and process validation under Good laboratory practice GLP regulations.