Quality Operation

Quality at ACME is clearly demonstrated in all stages of product lifecycle. Quality Operations begin at the test facilities with careful documentation.  This ensures compliance with current Good Manufacturing Practice (cGMP) and consequently, the integrity of the data produced. Quality Operation then follows through production and distribution, and concludes with shelf-life surveillance.

Quality Operation

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ACME has state of the art manufacturing facilities and uses the most advanced testing equipment, to guarantee the quality of our products. ACME additionally supervises suppliers’ procedures in order to ensure that the highest quality materials are used in our products.

Once a product gains regulatory approval and enters routine manufacturing, quality is guaranteed throughout the process, for both drug substances and drug products.During production:

–  Manufacturing processes are validated and equipment is tested and certifie
–  Test methods are validated to ensure that each product is of reproducible quality
–  Cleaning Processes are validated to ensure the safety of finished products from contamination.
–  Continuous improvement practices are employed so that processes and procedures are continually updated.

Quality doesn’t end when the product is released. ACME continues to monitor its products throughout their shelf life. Representative batches of all products are checked for stability to ensure that products remain safe and effective throughout their shelf life.The company places outstanding facilities equipped with most modern instruments, equipments and laboratory building to meet the world class standards like ISO, WHO, cGMP, UK MHRA, US FDA, PICS etc. Our quality operations staffed with trained and highly qualified professionals. All QO, QC & IPQC personnel are amply educated, experienced and highly motivated seasoned professionals.

All quality procedures, protocols & SOPs are clearly written, approved, implemented and recorded. Dedicated and experienced pharmacists, chemists and bio-chemists are working round-the-year to develop high quality generic formulations.

With an aim to ensure highest obtainable quality products (Pharma & Veterinary medicinal products) and customer satisfaction in market, ACME’s Quality Operation Division is responsible for constant monitoring of the components to be used in different production stage of any medicine. Equipped with modern instruments & calibration and validation process and well trained & qualified personnel Quality Operation Division strictly adheres to the cGMP guidelines for sampling, inspecting and any sort of chemical and microbiological testing etc.

Total Quality Assurance (TQA) is ACME’s avowed people oriented commitment for ensuring the highest obtainable quality products and customer satisfaction.

 

Total Quality Assurance

 

Under the umbrella of Quality Operation, manufacturing process at ACME is carried out stringently in accordance with the provisions of ISO-9001:2008 and WHO’s Current Good Manufacturing Practice (cGMP) standards. Accordingly, all employees and functionaries adhere to the well documented Standard Operating Procedures (SOP) for achieving the prime objectives of ensuring high quality in all of its products & services.

The Quality Operation Division of ACME has outstanding facilities, equipped with latest instruments such as HPLC, GLC, AAS, UV-VIS, FTIR, particle size analyzer polarimeter, potentiometric titrator with KF, Liquid particle counter Laminar Air Flow, microscopes etc. Personnel are trained and highly qualified. All procedures for sampling testing and inspecting are clearly written, approved, implemented and recorded and all process, equipments or systems are validated ensuring quality requirements, systems and procedures to meet cGMP.

High tech Chemical and Micro-biological Lab

 

Manpower training being the essence of good performance, the Total Quality Management System is given due importance at ACME. Through in-house and external training programs, we ensure that our key personnel remain abreast of the latest concepts of cGMP needs.