Ensuring Quality at Every Step of operation :

A Comprehensive Approach at Anamol Laboratories Pvt Ltd

Embracing the Quality Circle is a Mindset

At Anamol Laboratories, the concept of quality control is not just a series of steps, but a holistic approach that encompasses the entire product lifecycle. This is known as the Quality Circle mindset, where the focus on quality begins from the initial product design and continues until the final result reaches the customer’s hands.

Controlling Quality at the Input Stag

The first step in quality control process is to ensure the quality of inputs. This includes the raw materials, packaging materials, and the quality control process. The company carefully selects the brand, make, and supplier of these inputs to ensure they meet the necessary specifications, product’s requirement and consistency in supply.

Raw Materials

Anamol’s quality control team thoroughly examines the raw materials, verifying that they are of the approved brand, make, and supplier. This is crucial because the supplier’s handling and storage conditions can significantly impact the quality of the raw materials.

Packaging Materials

Packaging materials are equally important, as they directly come into contact with the reagents. We differentiate between primary and secondary packaging materials, ensuring that both meet the necessary standards and specifications as well as compatibility.

Quality Control Processes

The quality control processes themselves are also meticulously designed and implemented. Anamol utilizes well-accepted quality control standards, reference materials, and methodologies to ensure the accuracy and reproducibility of their testing procedures which involves equipment’s operations as well.

Designing and Developing Formulations

Once the inputs are under control, Design and development team takes over the formulation process. This stage involves extensive documentation, including design history files and master formula records, to ensure the standardization and traceability of the formulation developmental  stages.

The team designs the formulations in a way that regulates the quantity and quality of the materials used, as well as the final presentation of the product, whether it’s in liquid, dry powder, or rapid test form.

Standardizing the Manufacturing Process

The manufacturing process at Anamol is also standardized, with every step carefully controlled and documented. This includes the environmental conditions, the use of instrumentation, the labelling and printing processes, and the in-process quality control (IPQC) measures.

Anamol’s manufacturing team strictly adheres to the standard operating procedures (SOPs) to ensure that no step in the process is deviated from the established protocols and permissible limits of variations.

Ensuring Product Features and Characteristics

The end result of quality control efforts is a product with well- defined features and characteristics. These include the product’s presentation like accuracy, linearity, sensitivity, precision, and stability, as well as the identification and characterization of any interfering substances.

Anamol’s team carefully designs and tests these features and characteristics to ensure that the final product consistently delivers accurate and reliable results for their customers.

Achieving Accurate and Reproducible Results

The ultimate goal of Anamol’s quality control efforts is to ensure the accuracy and reproducibility of the results obtained from their products. This is achieved through a comprehensive approach that includes:

Alignment with standard reference materials:

Anamol’s quality control processes ensure that the product’s performance for refrence control values are aligned with the standard reference materials, guaranteeing the accuracy of the results.

Shelf-life stability:

Anamol designs their products to have a shelf life of at least two years, ensuring that the results remain accurate and consistent throughout the product’s lifespan.

Traceability and documentation:

Anamol maintains detailed documentation, including Master Formula Records (MFR) and Batch Process Reports (BPR), to ensure the traceability of their quality control processes and the ability to provide regulatory compliance when required.

Conclusion

Anamol Laboratories’ approach to quality control is a comprehensive and holistic one, encompassing every stage of the product lifecycle. By meticulously controlling the inputs, designing and developing formulations, standardizing the manufacturing process, and ensuring accurate and reproducible results, Anamol demonstrates its commitment to delivering high-quality products that meet the needs of its customers and regulatory requirements.

This commitment to quality is a core value that permeates every aspect of Anamol’s operations, ensuring that their customers can trust the reliability and accuracy of their products.