Quality Management

Quality Policy & Culture

At ACI Healthcare Ltd., we believe healthcare is more than a business , it’s a responsibility. Every day, our teams work with passion and purpose to develop quality products and solutions that support healthier communities across the country. We nurture a culture where fresh ideas are encouraged, accountability is valued, and teamwork fuels progress. Here, you’re empowered to take initiative, expand your skills, and contribute to work that truly matters. If you’re driven, ambitious, and ready to be part of an organization committed to excellence and positive impact, ACI Healthcare Ltd. offers the platform to grow your career while making a real difference in people’s lives.

Our Quality

AHL Quality Policy

Patient Safety

Data Integrity Policy

Regulatory Compliance

AHL Quality Policy

Regulatory Compliance Section

ACI HealthCare Limited (AHL) is consistently recognized by global industry bodies, strategic partners, and tier-one regulatory agencies for its uncompromising commitment to quality, innovation, and equitable healthcare access. These accolades are not merely honors; they are a reflection of our rigid adherence to international standards across every market we serve.

Domestic & Global Standing

Within the highly competitive landscape of Bangladesh—a pharmacy.. See More

Market Rank

Consistently ranked within the Top 8 of over 250 manufacturers.. See More

International Certifications

Certified by leading international regulatory bodies ensuring our products meet global quality benchmarks.. See More

Export Markets

Exporting to over 30 countries with a strong presence in regulated and semi-regulated markets worldwide.. See More

Quality Management

Certifications &
Awards

Quality Management

Quality Control
(QC) and Quality
Assurance (QA)

Our Quality Control (QC) laboratory is equipped with high-end analytical instrumentation to support global compliance for regulated markets.

Beyond stability and environmental monitoring, QC ensures data integrity through Analytical Data Sheets (ADS) and formal Certificates of Analysis (CoA).

Quality Control (QC)

Laboratory Infrastructure

Operating as a centralized hub of analytical excellence, the Quality Control Laboratory maintains strict functional independence from production to ensure unbiased oversight across the entire product lifecycle.

This unit governs the rigorous testing and disposition of raw materials, packaging components, intermediates, and finished products, verifying absolute conformance to approved specifications prior to further processing or global market release. All analytical methodologies are anchored in Marketing Authorization standards and validated in accordance with gold-standard benchmarks, providing high-precision parameters for instrumentation, reagents, and system suitability criteria.

Beyond routine stability and environmental monitoring, the QC department oversees laboratory assets, reference standards, and OOS/deviation investigations, ensuring all data is meticulously captured in Documentation and formalized via a definitive Certificate of Analysis (CoA). By fusing technical rigor with compliant archiving, QC serves as the strategic gatekeeper under Quality Unit for ACI’s global cGMP integrity and regulatory reliability.

Our Quality Control (QC) laboratory is equipped with high-end analytical instrumentation to support global compliance for regulated markets. Beyond stability and environmental monitoring, QC ensures data integrity through Analytical Data Sheets (ADS) and formal Certificates of Analysis (CoA).

Beyond routine stability and environmental monitoring, the QC department oversees laboratory assets, reference standards, and OOS/deviation investigations, ensuring all data is meticulously captured in Documentation and formalized via a definitive Certificate of Analysis (CoA). By fusing technical rigor with compliant archiving, QC serves as the strategic gatekeeper under Quality Unit for ACI’s global cGMP integrity and regulatory reliability.

Beyond routine stability and environmental monitoring, the QC department oversees laboratory assets, reference standards, and OOS/deviation investigations, ensuring all data is meticulously captured in Documentation and formalized via a definitive Certificate of Analysis (CoA). By fusing technical rigor with compliant archiving, QC serves as the strategic gatekeeper under Quality Unit for ACI's global cGMP integrity and regulatory reliability.

Our Quality Control (QC) laboratory is equipped with high-end analytical instrumentation to support global compliance for regulated markets. Beyond stability and environmental monitoring, QC ensures data integrity through Analytical Data Sheets (ADS) and formal Certificates of Analysis (CoA).

Beyond routine stability and environmental monitoring, the QC department oversees laboratory assets, reference standards, and OOS/deviation investigations, ensuring all data is meticulously captured in Documentation and formalized via a definitive Certificate of Analysis (CoA). By fusing technical rigor with compliant archiving, QC serves as the strategic gatekeeper under Quality Unit for ACI's global cGMP integrity and regulatory reliability.

The laboratory utilizes advanced technology (but not limited to following) to guarantee product quality and regulatory reliability:

Chromatography & Spectroscopy

15 UPLC/HPLC units (PDA/UV), Gas Chromatography with HS Analyzer, and spectroscopic tools including FTIR and UV.

Specialized Analysis

Laser-based particle size analysis, Inductive Couple Plasma (ICP-OES), and Differential Scanning Calorimeter (DSC).

Dissolution & Stability

9 Dissolution units with auto-samplers and 5 walk-in stability chambers for rigorous lifecycle testing.

Microbiology & Support:

Equipped with incubators, autoclaves, Bio-Safety cabinets, and Total Organic Carbon (TOC) analyzers.

Quality Assurance (QA)

Assurance (QA) Processes

The Quality Assurance (QA) department functions as the strategic epicenter of ACI HealthCare Limited (AHL), orchestrating a robust pharmaceutical quality system designed to exceed global cGMP benchmarks across the entire product lifecycle. By harmonizing rigorous oversight with meticulous documentation, QA serves as the definitive guarantor for the safety, efficacy, and consistent quality of our medicinal portfolio.

Operational Pillars of AHL Quality Assurance

Quality Management System: The site maintains a robust Quality Management System (QMS) engineered for continuous improvement and strict cGMP compliance. The framework is anchored by a triad of top-tier documents—the Quality Policy, Quality Manual, and Quality Modules—which harmonize USFDA guidance, EudraLex Volume 4, WHO standards, ICH Q10 principles, and ISO 9001:2015. While the Corporate Quality Organization governs these high-level directives, site-specific units manage the execution through SOPs, protocols, and formats aligned with Marketing Authorizations.

AHL's QMS integrates four core elements: Quality Planning, Implementation, Control, and Feedback-driven Improvement. Operations are digitally transformed through a suite of advanced platforms from Novatek International, including an Electronic QMS (e-QMS) for Document Management, Change Control, and CAPA, alongside a dedicated Laboratory Information Management System (LIMS) and SAP ERP. This infrastructure is perpetually refined through periodic domestic regulatory inspections, self-inspections, and external audits by international agencies and consultants.

Batch Integrity & Change Management
QA holds final authority for batch release and provides rigorous oversight for Change Control and Deviation management systems.
Investigative & Corrective Excellence
The department leads high-impact failure investigations, market complaint analysis, and the implementation of Corrective and Preventive Actions (CAPA).
Real-Time IPQA & Compliance
QA delivers continuous In-Process Quality Assurance (IPQA), self-inspections, and specialized laboratory process quality assurance to maintain operational standards.
Risk & Documentation Governance
The unit directs Quality Risk Management (QRM) and approves all critical master documents, including BMRs, BPRs, protocols, and specifications.
Internal Audit
AHL maintains a rigorous Self-Inspection system managed via the Novatek e-QMS Audit Module, ensuring all GMP operations undergo comprehensive review as per standard practice.
Training/ Personnel Qualification
AHL anchors its operational excellence in a culture of technical mastery, driven by a rigorous, multi-tiered training ecosystem that exceeds USFDA, EU GMP, and WHO standards.
Supplier & Partner Governance
The department executes comprehensive supplier evaluations and manages contracted services (CTL/CMO) through formal Quality Agreements to ensure total alignment with AHL standards.
Lifecycle & Supply Chain Stewardship
QA governs training management, reserve sample retention, and the orchestration of recall or withdrawal protocols when required.
Batch Integrity & Change Management
QA holds final authority for batch release and provides rigorous oversight for Change Control and Deviation management systems.
Investigative & Corrective Excellence
The department leads high-impact failure investigations, market complaint analysis, and the implementation of Corrective and Preventive Actions (CAPA).
Real-Time IPQA & Compliance
QA delivers continuous In-Process Quality Assurance (IPQA), self-inspections, and specialized laboratory process quality assurance to maintain operational standards.
Risk & Documentation Governance
The unit directs Quality Risk Management (QRM) and approves all critical master documents, including BMRs, BPRs, protocols, and specifications.
Lifecycle & Supply Chain Stewardship
QA governs training management, reserve sample retention, and the orchestration of recall or withdrawal protocols when required.
Supplier & Partner Governance
The department executes comprehensive supplier evaluations and manages contracted services (CTL/CMO) through formal Quality Agreements to ensure total alignment with AHL standards.
Training/ Personnel Qualification
AHL anchors its operational excellence in a culture of technical mastery, driven by a rigorous, multi-tiered training ecosystem that exceeds USFDA, EU GMP, and WHO standards.
Internal Audit
AHL maintains a rigorous Self-Inspection system managed via the Novatek e-QMS Audit Module, ensuring all GMP operations undergo comprehensive review as per standard practice.
Quality Management

Data Integrity and Documentation

AHL upholds a sophisticated Data Governance Framework designed to ensure absolute transparency, traceability, and reliability across all pharmaceutical operations. Our commitment to data integrity is not just a policy but a strategic pillar that protects our global regulatory standing and patient safety.

The AHL Data Governance Architecture

Policy-Driven Integrity:
All operations are governed by a rigorous, site-wide Data Integrity Policy that aligns with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
Procedural Standardization:
Governance is operationalized through a suite of Standard Operating Procedures (SOPs) that define strict controls for data entry, modification, and archival across both manual and electronic systems.
Executive Oversight:
A structured reporting hierarchy ensures that data integrity trends, potential risks, and audit outcomes are consistently communicated to Top Management, fostering a top-down culture of accountability.
Digital Transformation:
By leveraging the Novatek e-QMS, LIMS, and SAP ERP, we eliminate manual vulnerabilities through automated audit trails, restricted user access levels, and electronic signatures that comply with 21 CFR Part 11.
Continuous Monitoring:
Regular internal audits and self-inspections specifically target data governance to ensure the site remains in a perpetual state of "Audit-Readiness" for international agencies like the USFDA and EMA.