Introduction

At Anamol Laboratories Pvt. Ltd., we believe quality is a result of a series of well-planned actions to achieve a specific objective. In case of diagnostic test system, the ultimate purpose is patient benefits and affordability. Our role as a manufacturer is critical as any manufacturer puts his willingness to build good quality or otherwise.

Customer First

Quality is an experience of the customer. Product quality perception comes from specifications of product design and the manufacturing standards achieved. Because of this reason, “Customer First” is our philosophy. We are well aware of the fact that quality in our products or service is not what we put in but what our customers take out. It is always our sincere attempt to sell not just a product, but value and experience.

Competency and Attitude

Quality starts well before the purchase of raw materials. Building good quality is a matter of choice. One may have a complete attitude to build a great quality product or service-but may lack the necessary skills and competency to do so. On the other hand, one may have all the skill-sets and knowledge to build a great product or service-but may not have the willingness or desire to do so. We believe, it takes a balanced combination of both Competency and Attitude to create quality. Our attitude to create quality always pushes us from our comfort zones to acquire or upgrade our competencies. The vast experience and knowledge of the team members acts as bonus over existing culture.

Research and Development

With changing times, the needs of markets and customers change. Our continuous R&D activity helps us to create new products and solutions for the changing needs or to add new features in our current products by challenging conventional performance limitations. Our R&D specifications clearly define purpose of diagnostic test systems such as Accuracy levels, Sensitivity limits, Precision (within and between run), Linearity, Interferences, Uncertainty, Traceability to international standards, etc. We communicate and remain in close contact with our customers to understand their requirements. In other words, our customers play an important role to guide us for our future activities.

Raw Materials

Most of the enzymes used by us are Genetically Engineered (GE) grade from the best sources across the globe leading to high sensitivity, specificity and performance characteristics. We employ Zwitter ionic buffers where enzymes, biochemicals and co-factors exhibit consistent and stable performance. Quality of water is of utmost importance as it is over 90% in most of the reagents. The water used for manufacturing goes through 5-step purification process to obtain highest purity and lowest contaminants. Only 25% water is recovered after such tough process which qualifies for our use. We only use AR grade (highest purity) chemicals from the most reputed manufacturers.

Formulations

Our formulations have a very high conformation to international bodies like The International Federation of Clinical Chemistry (IFCC), German Society for Clinical Chemistry (GSCC or DGKC) and The Scandinavian Committee on Enzymes (SCE) making our products acceptable to international standards.

Production Environment

All the products are manufactured under controlled environment such as particle-free zones, low humidity chambers and low total microbial counts. Our high-end sophisticated equipments are well maintained and well calibrated to ensure precise specifications of volumes and purity. Finished products or goods-in-process are stored only in virgin plastic containers having desirable specifications. Regular disinfections of manufacturing rooms and equipment are employed to ensure minimum breakdowns. The manufacturing process employs multiple check points resulting in release of only those products which meet all quality specifications.

QA and QC Protocols

Global quality is our philosophy. We have developed our internal QC specifications which not only checks the quantities of components in the reagent systems but also checks their functional performance and characteristics, which is unique to us. We also check other parameters of the reagent systems such as pH, blank of the reagent, shelf life study at different temperatures, accelerated stability study, etc. Every batch of products manufactured get tested against 4 independent third-party controls of normal as well as pathological range. Only upon satisfactory performance, the product is released into the market. In addition to this, we participate in various External Quality Assurance Services (EQAS) programs by national and international bodies.

Packaging Materials

We employ packaging materials from reputable sources through strict vendor and material specification criteria. All of our plastic and glass materials are made from virgin raw materials. Stringent 4-step washing procedure makes our materials inert and leach-proof. We also have strict leakage and breakage tests to ensure the packaging material does not compromise on our reagent quality. In few cases, we have developed customized packaging materials as per customer demands to ensure temperature stability and protection for long-distance transports.

Storage Environment

Our storage space spans about 700 sq. ft. in area which has controlled environment of temperature, humidity and light. Proper classification of sub-areas helps to assign and keep the products in designated areas for easy retrieval.

Shipment Partners

Multiple shipment partners allows us to ship materials from few grams to tons in weight and size. We have separate shipment partners for multiple geographical territories domestic and abroad that meet our requirements of time of deliveries, transport temperatures, etc. All our shipment partners have efficient web based tracking systems of consignments.

We believe quality is not a static concept but needs continuous improvements to meet newer demands and challenges offered by changing markets, customers and pathogens and diseases.