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DML License No. 000776

Quality Assurance Department

RADIANT PHARMA has a dedicated (Q.A.) Quality Assurance Department which ensures the execution of effective quality systems and procedures to meet local and international regulatory requirements and to provide well-timed release of quality materials and final products. The Quality Management System (QMS) at Radiant Pharma is based on ICH, WHO & DRAP guidelines with the objective of early identification of problems via a continuous improvement cycle, sustainability and precision initiatives.

It is focused on a Quality Policy and an objective to meet customer requirements. Quality, purity, efficacy and safety of products are of supreme importance at Radiant Pharma. All Radiant Pharma products are manufactured at the company’s cGMP compliant manufacturing facility.

Description of the Quality Management System

Elements of Quality Management System implemented in Radiant Pharma (Pvt.) Limited are :

Quality Policy:

For the implementation of effective Quality Management System the Organization has established its policy and ensures that it

Provides a framework for establishing and reviewing objectives.

Is communicated, understood and implemented throughout the Organization.

Is reviewed for continuing suitability at appropriate level of the Organization.

The Quality Policy is communicated and enforced through management reviews, training displays in Urdu and English at appropriate locations in Organization. Regular sessions are conducted with existing employees and new employees to ensure that Quality Policy is understood by all.

General Requirement of Quality Management system:

To implement these Quality Systems, the Organization has managed to:

Identify the processes and its potential environmental, safety and health impact needed for the Quality Systems

Determine the sequence and interaction of these processes

Determine criteria and methods required to ensure the effective operation and control of these processes.

Ensure the availability of information necessary to support the operation and monitoring of these processes.

Measure, monitor and analyze these processes.

Implement actions necessary to achieve the planned results and continual improvement.

The Organization manages these processes in accordance with the requirements of these standards.

Documentation Requirements:

The Organization has prepared its Quality System documentation, which includes:

Standard Operating Procedures

Batch Manufacturing Record

Master Formula

Quality Form

Job Description

Quality Drawing

Material Specification (Raw & Packaging)

Control of Documents:

The Organization has established a procedure for controlling documents used in its Quality System. This control ensures that the:

Documents are approved for adequacy prior to release.

Documents are reviewed, updated as necessary

Documents are identified with current revision status

The relevant versions of documents are available at all locations where necessary.

Documents remain legible, readily identifiable and retrievable

Obsolete documents are removed from all points of issue or use, or are otherwise controlled to prevent unintended use. Any obsolete documents retained for legal or knowledge preservation purposes are suitably identified.

Control of Records:

Quality records are maintained, controlled, identified, stored, retrievable, protected, disposed after retention time as per procedure to demonstrate conformance to requirements and effective operation of the Quality System.

Management Commitment:

The Organization’s management is fully committed to quality, environment safety and health precautions and demonstrates its commitment to the development and improvement of its Quality System.
The Organization produces products that fully and consistently satisfy the needs of our customers.

Management Focus:

The Organization is having a goal of achieving customer confidence and maintaining safe, environmental friendly and healthy atmosphere within the Organization as well as to the community.
International Standards and Regulatory requirements are properly considered while determining the needs for quality product, controlled environment, and employee health and safety.

Customer Focus:

The Organization’s management meets the customer expectations and satisfaction level for the quality product by ensuring through:

Objectives and Targets:

The Organization has established quality objectives and targets at appropriate functions and levels. These objectives are defined in measurable terms and are the interpretation goals of policy deployment in each department/section. These objectives are set annually in the Management Review consistent with the Organizational policy, and the commitment to continual improvement and meeting management focus and regulatory requirements.

Legal and Regulatory Requirements:

The Organization has established and maintained a procedure to identify and have access to legal and regulatory requirements to which the Organization subscribes, that are applicable to the activities of the Organization. The Plant Manager is responsible for keeping the legal and regulatory requirements up dated at all times.

Legal and Regulatory Requirements:

The Organization has established and maintained a procedure to identify and have access to legal and regulatory requirements to which the Organization subscribes, that are applicable to the activities of the Organization. The Plant Manager is responsible for keeping the legal and regulatory requirements up dated at all times.

Responsibility and Authority:

The Job Description describes the responsibilities and authorities of the Organization’s personnel. The relevant Standard Operating Procedures also describe the responsibilities of personnel in relation to various quality system requirements.

The Responsibility Matrix shown in Section of this Quality Manual describes the prime and secondary responsibilities of each department/section against the requirements of Quality Systems

The Organizational Chart shown in Section 5.0 of Quality Manual describes the hierarchical structure of the Organization.

Quality Policy of Radiant Pharma (Pvt.) Limited is

The Management of Radiant Pharma (Pvt.) Limited is committed to:

Produce supreme quality products that meet all international standards.

Meet and exceed customer expectations.

Meet all applicable regulatory requirements and system standards.

Be safe and environment friendly to employees and the community.

Protect the social rights of employees.

Continuously improve the skills, systems and business of the Organization.