Quality Policy

Our strong conviction in quality is not only limited to conformance to requirements, but is aimed at maximizing the value of the product to the consumer.

It is our endeavor to develop inbuilt quality by using good product design best available resources, time tested techniques, through tireless quality assurance.

Our Quality objectives are :
(i) To create an organization culture which promotes quality consciousness and continuous improvement at all levels.
(ii) To provide safe, hygienic working conditions.
We are committed to implement and maintain a quality system which is in line to fulfill our quality policy.

Ruan Life Sciences Pvt Ltd provides consistent quality to the customers. Strict quality assurance is inherent in every step of our process, from incoming raw materials to shipment of the finished product. Each of our raw materials is selected by our experienced purchasing department, based on strict physical and chemical criteria.

The Quality Assurance Department ensures that the manufacturing facilities and procedures are standardized to provide the international quality attributes to the products consistently for each batch through a well-documented, validated and audited system.

Ruan Life Sciences Pvt Ltd is fully equipped with gas chromatograph, spectrophotometers and other high-tech apparatus; as also micro-biological facilities to check the quality of raw material, semi-finished products and finished products following Good Laboratory Practices by qualified and approved chemists.

The Company follows Quality Standards for the manufacture of Bulk-Drug and Intermediates. Our business aim is to follow a safety system, and adhere to the responsible care programme and most of all provide customer satisfaction. For this purpose, the Company has acquired the required Licenses and Permissions from various Government Agencies to set the pharmaceutical and industrial standard.

To achieve and sustain market leadership for the products in national & international market by providing to meet the requirements of customer. This is achieved through the following quality objectives.
• Development of approved vendors and procurement of raw material from approved sources.
• Continuous R&D efforts to improve the process and quality.
• Strict systematic QC procedures in establishing the quality of the product.
• Education and training of employees to improve the quality.
• Adherence to cGMP norms as an integral part of the total quality management system.
• Assessment of changing requirements of customer expectation and meeting them.

Develop environmental awareness among employees and adherence to pollution control norms.

 

We have a modern and well-equipped Quality Control (QC) laboratory, which ensures that our products are pure, safe, effective and are released only after thorough analysis as per stringent specifications, methods and procedures developed according to international guidelines.

LIST OF EQUIPMENT FOR QUALITY CONTROL
- UV / Visible And IR Spectrophotometers
- Metrohm Auto Titrator
- High Performance Liquid Chromatography(HPLC)
- Atomic Absorption Spectrophotometer
- Electronic Micro And Semi Microbalances
- Dissolution Test Apparatus
- Disintegration And Friability Testers
- Digital Conductivity, TDS And Ph Meters
- Auto Clave, Hot Air Oven, Laminar Air Flow.
- Many others.

QC DEPARTMENT
Our QC department has all necessary instruments for analysis of API, finished products, packaging and related materials used. The QC department performs following activities:
- RM/PM analysis (Flowchart)
- Finished Products analysis (Flowchart)
- In-process Checks (Flowchart)
- Stability Studies
- The QC activities are managed through four sections
- Instrumental Analysis and Finished Products
- Wet Analysis Laboratory
- Microbiological Testing Laboratory
- Packaging Material -Testing Laboratory

QUALITY ASSURANCE
Ruan Life Sciences Pvt. Ltd. quality policy is mandated and supported by the Executive Management and coordinated by an independent Quality Assurance (QA) Department.

Highlights:
• Pharmaceutical plant with ISO 9001, revised Sch.M & WHO-GMP certification.
• Quality Assurance is independence of Manufacturing.
• In-Process quality is checked during manufacturing.
• Validation of facilities, equipment, process, products & cleaning as per Master Plan.
• Complaint Handling.
• Storage of quality record and control samples.
• Stability Studies.
Quality Assurance Department handles the following activities

Validation:
• Preparation of validation plans for facility / equipment / process including cleaning.
• Approval of protocols for validation of facility / equipment / product / process.
• Team member for execution of validation of facility / equipment / product / process.

Documentation Control:
• Controlled distribution and archiving of documents.
• Control of changes made by proper change control procedure.
• Approval of all documents.

Assuring Quality of Products
• SOP compliance.
• Audit of facility for compliance.
• Line clearance In-process counter checks
• Critical sampling
• Record verification
• Release of batch for marketing
• Investigation of market complaints
• Stability of products

Quality Improvement Plans:
• Feedback received from the compliance team
• Proposals for corrective & preventive actions
• Annual products review
• Trend Analysis of various quality parameters for products, environment & water.

POLICY
Our Mission is to contribute to the healthcare of people across the globe, by supplying quality medicines at affordable price.
We commit ourselves to inculcate and implement Good Manufacturing Practices to ensure Quality, Safety & Efficacy of all our products.
We also pledge to safeguard our environment through eco-friendly measures.

QUALITY ASSURANCE ACTIVITIES
The QA functions to implement and monitor the compliance to cGMP requirements which are well defined right from procurement of raw materials, packing materials, in-process controls, finished products and their release activities.
The Quality Assurance system is supported by well-defined organogram specifying hierarchy and individual job responsibilities.
The Quality Assurance Procedures (QAPs) define the Quality Requirements and responsibilities of the activities involved.
Standard Operating Procedures (SOP) are available, detailing step-by-step actions to support specific activities in the procedures, where their absence would adversely affect the activity being performed.