Our clinical pathologists are available seven days a week to render diagnoses.
Project info
Quality Operations
Helix Pharma’s quality operations are customer centric and ensure that the end consumer of its products- the patient – is prescribed a safe, efficacious, cost effective and quality product that delivers on expectations everything for all the patient. This is only possible when quality is embedded in the core of what we do from ‘word so’. Our QOs are compliant with GMP, GLP — to ensure consistent quality. Our Quality Control Lab is ISO –. Helix risk base assessment of its operation (DIRA) has led us to develop very robust control & monitoring system, that ensure regulatory as well as EHS compliance. Our certifications include: 1S0 9001 — with 17025 in process –
QC Laboratory inputs are fundamental to maintaining pharmaceutical quality systems. Compliance with global guidelines It plays a pivotal role in ensuring that pharmaceutical products meet required quality, safety, and efficacy standards before release. It operates under the principles of Good Manufacturing Practice (GMP) and guidelines such as ICH Q2(R2), ICH Q6A, WHO TRS 986, and ISO/IEC 17025. QC laboratories provide analytical evidence throughout product development, manufacturing, and post-marketing stages to guarantee compliance and reliability of results.
Helix Pharma Quality Control (QC) Laboratory functions under international standards such as ICH Q2(R2), ICH Q6A, WHO TRS 986, ISO/IEC 17025, and GMP principles to ensure product quality, safety, and efficacy. QC testing covers all materials and stages, starting from Testing of raw materials & packaging components, using pharmacopeia standards (USP <851>, BP, EP, JP) and ICH Q6A for specification setting to ensure APIs and excipients conform to identification, purity, and potency criteria. Than Performed finished products testing in compliance with ICH Q6A, ICH Q8(R2), and pharmacopoeia monographs (USP, BP, JP, Int. Ph. etc) to ensure that the product meets critical quality attributes before release finished products. To Assure the Quality of Product till shelf life, stability studies conducted as per ICH Q1A(R2) guidelines for stability testing of new drug substances and products to determine the shelf life and recommended storage conditions of the product. Microbiological tests i.e. Microbial limit test, sterility test, endotoxin test, and environmental monitoring follow USP <61>, <62>, <71>, and environmental controls per <1116> to ensure aseptic integrity.
All above analyses performed using advanced calibrated and qualified instruments like HPLCs (UV-Vis, PDA, RID), UV, Analytical/Semi micro Balances, pH Meter, FTIR, Dissolution Testers Stability Chambers, Particle Counter, Autoclave, LAF units etc. To insure the testing method effectiveness Analytical methods are validated and verified as per ICH Q2(R2) & CDP (Comparative Dissolution Profile) against the Innovator product according to FDA. Which lead us to meet the export quality Standards Documentation is maintained under ALCOA+ and 21 CFR Part 11 for data integrity, supported by Software systems. QC data supports regulatory submissions, batch release, guidelines. Overall, the QC laboratory’s integrated analytical, microbiological, and documentation framework ensures compliance, traceability, and scientific reliability, forming the foundation for consistent product quality and patient safety.
