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Quality Assurance
QA/QC
Quality control is an essential operation of the pharmaceutical industry. Sigma Softgel & Formulation is committed to better healthcare for all, through quality products, achieved through manufacturing excellence, compliance to requirements and continual improvement in quality management system, for maximum customer satisfaction.
We believe that a solution becomes a success when it conforms to the quality specifications by the customer every time, meeting world-class standards. Sigma Softgel & Formulation implements an unmatched global quality management system that is based on the desire to sustain a culture of operational excellence. Sigma Softgel & Formulation employs the best of industry’s technical officials in its QC, QA, and production and product development department. Their continuous proactive efforts on the present and future needs of market are dedicated to meeting the customer requirements through consistent development of technology, quality, drug delivery systems, and packaging. Our company’s passion for quality goes way beyond business and statutory requirements.
Sigma Softgel & Formulation aims to provide its customers with Novel Drug Delivery Systems and services including formulation development, Analytical method development and stability studies. The Tests are carried at par with highest standards of quality, reliability and compliance. Sigma’s Success is the result of focusing on clients requirements at affordable cost & consistent quality. Customer Satisfaction / Service is on the priority list and it understands that the Association should result in its own growth and also the success of the clients.
Sigma Softgel & Formulation is committed to better healthcare for all, through quality products, achieved through manufacturing excellence, compliance to requirements and continual improvement in quality management system, for maximum customer satisfaction. Giving utmost importance to quality, Sigma Softgel & Formulation has developed a sophisticated system and seamless procedure throughout the organization. This minimizes risk and enables us to produce superior quality products.
Sigma Softgel & Formulation implements an unmatched global quality management system that is based on the desire to sustain a culture of operational excellence. Our company’s passion for quality goes way beyond business and statutory requirements. Sigma Softgel & Formulation has reliable standards and is a manufacture of best quality products that satisfy norms set by all multinationals and large pharmaceutical houses, qualifying for international and national sales.
Quality Control
Quality control is an essential operation of the pharmaceutical industry. We have well experience qualified & competent dedicated technical persons in Various departments. Our QC department has all necessary instruments for analysis of API, finished products, packaging and related materials used.
Quality Control refers to the features and characteristics of a product that bears on its ability to satisfy the needs of the consumer. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable.
Our Quality Management Systems (QMS) complies with various international regulatory and cGMP standards and we perform periodic reviews of systems, practices and documentation in place across our manufacturing facilities through regular audits. All products are subjected to extensive stability testing programs to understand the real product behaviour during shelf life. We also monitor in-market product quality through annual product quality review mechanisms.
The QC department performs following activities:
RM/PM analysis
RM/PM analysis
Finished Products analysis
In-process Checks
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
Quality assurance department, a fully autonomous functionality is in place to keep track of each activity, parameters & processes to achieve the quality goal in totality. Quality of each medicinal product is assured by applying TQM techniques by the QA-Team. Quality assurance is a wide concept that covers all aspects that collectively or individually impact the quality of the product. That is, the sum of organized arrangements that are made with the aim of ensuring pharmaceutical products are of the required quality as per the intended use. Quality assurance is a good practice in the manufacture of pharmaceutical products, as it is the process of vouching for integrity of products to meet the standard for the proposed use. It is an obligation that ensures manufacturers meet the needs of end-user needs in terms of safety, quality, efficacy, strength, reliability and durability.
Objectives of Quality Assurance
To ensure the law is complied with to the latter.
To offer protection of the manufacturing organization.
To offer a guarantee that the person who is administering medicine is confident that every unit will achieve the desired effect.
To protect users for products from possible accidental defect in the manufacture, design, storage as well as usage instructions.
Credentials
DL2-001
DL3-001
ESI
FIR
GLP-001
GMP-001
GST
ISO 9001 2015
POLLUTION CONTROL BOARD
WHO GMP
