Quality Management

Ensuring Compliance to Deliver High Quality Products Consistently

At Alex, excellence through Quality and Compliance is one of the core values and we strive to achieve it consistently across all functions associated with Research and Development, Manufacturing, Testing, Release, and Distribution of our differentiated products. At Alex, we follow Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) laid down by Schedule M, Schedule L, ICH Q7 and TRS guidelines throughout our operations without compromising on compliance, to ensure high standards of quality consistently.

Experts on hands

A strong, well-trained Quality team monitors every step of the development and manufacturing process to ensure every product complies with internationally accepted good practices and standards of quality, purity, efficacy, and safety.

Ensuring Regulatory Compliance

We address the increasingly demanding benchmarks of stringent global regulatory agencies through our best-in-class technology and processes. Our Quality Control and Quality Assurance teams ensure compliance with WHO-GMP to deliver high-quality products consistently.

Quality Control and Quality Assurance

Alex Pharmachem Private Limited is committed to the highest quality standard having well-equipped analytical laboratory and microbiological laboratory. Alex API's and Intermediates are specified and analyzed according to relevant pharmacopoeias and in-house specifications which compares with the relevant reference standards.

It is necessary for controlling the raw material, intermediates, final products, auxiliary materials and packing materials confirms to WHO-GMP. High quality of final product mainly depends on the careful selection of starting materials. Standard conditions of production and up to date technology ensure consistently high product quality. Analytical methods and specifications are both developed and validated by an experienced professional team that works in the analytical development section.