At Akums Drugs & Pharmaceuticals, quality is the foundation of everything we do. Our commitment to maintaining the highest standards of quality, purity, safety, efficacy, and cGMP compliance across all our products is unwavering.

As a leading Contract Development and Manufacturing Organization (CDMO), we understand that quality is not just about meeting standards—it’s about exceeding expectations.

Perspective and Deliverables

We at Akums belief that customer centric deliverables and our Quality Management System (QMS) is designed to ensure that every product we manufacture fulfil the quality standards of current national and international regulatory requirements.

We have established robust procedures to assure end-to-end quality standards by keeping patient health and safety in mind, covering all stages of the product lifecycle, from development, validation, stability and commercialization. Committed to ensure the stability of product throughout shelf life.

Pharmaceutical Quality System (PQS) at Akums

Quality Objective

Effective PQS has implemented to achieve quality objectives by adopting Quality Policy, Quality Planning and PQS tools.

Continual Improvement

Ongoing improvement and to ensure the product quality in a state of control through effective PQS tools like Change Management, CAPA Management.

Knowledge Management

A systematic approach followed for acquiring the knowledge from regulatory updates, external trainings, hiring regulatory consultants etc.

Risk Management

Scientific evaluation of potential risks and adequate mitigating actions adopted for developing the next level of quality.

Management Review and Monitoring

Periodic assessment to measure the performance and achievement of PQS and allocation of resources to enhance the PQS.

Quality Commitment

Management committed for consistent product quality by effective PQS, quality culture, resources, planning and review mechanism.

Change Management

Timely and effective changes governed through robust change control management system. Changes are evaluated by expert teams contributing their expertise and knowledge for continual improvement.

Quality Risk Management

A strong proactive approach for identifying, scientifically evaluating and controlling potential risks associated during manufacturing and ensure the product quality, patient health and safety.

CAPA Management

A structured approach for Corrective and Preventive Actions (CAPA) strategy followed for continuous improvement of processes and strengthen the procedures.

Audit Management & Regulatory Compliance

Schedule audits of all facilities are conducted to assess the compliance level as per national and international regulations.

Deviation and Incident

A structured approach to address the deviation and incident followed for continuous improvement of procedure.

Root Cause Analysis and Investigations

A systemic approach for identifying and analysing the root causes by following the different types of investigational tools to prevent the issues.

Pharmaceutical Quality System (PQS) at Akums

Quality Objective

Effective PQS has implemented to achieve quality objectives by adopting Quality Policy, Quality Planning and PQS tools.

Continual Improvement

Ongoing improvement and to ensure the product quality in a state of control through effective PQS tools like Change Management, CAPA Management.

Knowledge Management

A systematic approach followed for acquiring the knowledge from regulatory updates, external trainings, hiring regulatory consultants etc.

Risk Management

Scientific evaluation of potential risks and adequate mitigating actions adopted for developing the next level of quality.

Management Review and Monitoring

Periodic assessment to measure the performance and achievement of PQS and allocation of resources to enhance the PQS.

Quality Commitment

Management committed for consistent product quality by effective PQS, quality culture, resources, planning and review mechanism.

Change Management

Timely and effective changes governed through robust change control management system. Changes are evaluated by expert teams contributing their expertise and knowledge for continual improvement.

Quality Risk Management

A strong proactive approach for identifying, scientifically evaluating and controlling potential risks associated during manufacturing and ensure the product quality, patient health and safety.

CAPA Management

A structured approach for Corrective and Preventive Actions (CAPA) strategy followed for continuous improvement of processes and strengthen the procedures.

Audit Management & Regulatory Compliance

Schedule audits of all facilities are conducted to assess the compliance level as per national and international regulations.

Deviation and Incident

A structured approach to address the deviation and incident followed for continuous improvement of procedure.

Root Cause Analysis and Investigations

A systemic approach for identifying and analysing the root causes by following the different types of investigational tools to prevent the issues.

Regulatory Approvals and Certifications

Our facilities have been inspected and approved by leading global regulatory authorities, ensuring that our products are complies as per their requirements and safe, efficacious, reliable for patient.We ensure that our products meet the standards of compliance with Pharmacopoeial standards such as IP, BP, USP, EP etc. as per country specific requirement.

Asian Countries

India, Cambodia, Philippines, Sri Lanka, Vietnam, Nepal, Indonesia, Yemen etc.

African Countries

Ghana, Ivory Coast, Kenya, Libya, Malawi, Nigeria, Rwanda, Tanzania, Uganda, Ethiopia, Sudan, Zimbabwe, Zambia etc.

European Countries

Bulgaria

United State of America

For, Food and Neutraceutical Products

International Organization for Standardization (ISO) Certifications

Akums operates under a framework that guarantees compliance with national and international regulations, allowing us to serve both domestic and global markets confidently. Our facilities have been inspected and approved by leading global regulatory authorities, ensuring that our products are safe, effective, and reliable.

EU-GMP

Certified Good Manufacturing Practices by the World Health Organization, ensuring consistent quality production and control.

ISO 9001:2015

For robust quality management systems that guarantee continuous improvement and customer satisfaction.

ISO 14001:2015

Environmental management certification, reflecting our responsibility and commitment towards eco-friendly manufacturing and quality operations.

OHSAS 18001:2007

Occupational Health and Safety certification to ensure a safe working environment.

Our products undergo strict regulatory scrutiny, ensuring that they meet the standards of each country we operate in, including compliance with Pharmacopoeia standards such as IP, BP, USP, and EP.

Advanced Quality Control (QC) Labs

At Akums, we operate advanced Quality Control laboratories equipped with the latest technologies and instrumentation to conduct a wide range of testing. Our dedicated QC teams ensure that every material, intermediate, and final product is tested and verified for purity and potency.

Chemical Analysis

Advanced analytical testing using techniques like HPLC, UPLC, GC, FTIR, UV, ICP-OES, ICPMS, GCMS, LCMS, Laser Diffraction Technique etc.

Microbiological Testing

Rigorous testing for microbial contamination, ensuring the safety of sterile and non-sterile formulations, equipped with advanced instrument like Auto Culture Identifier, Rapid Sterility Tester etc.

Stability Testing

Stability testing conducted as per ICH requirement at different climatic zones for ensuring stable products across the globe.

Elemental, Genotoxic & Nitrosamine Impurity

Identifying, quantifying and controlling the undesired impurities generated during processing to ensure health and safety of the patient.

Digital Journey with Pharma 4.0

Digital technologies and advanced system has adopted aligned with pharma 4.0 revolution for digitalization.
Automation process has adopted for optimization of production processes, reduces human errors, makes faster, improve efficiency, higher quality standards, early identification of potential issues, and for leading to more consistent products.

Enterprise management system (SAP) has adopted for controlling the day to day business functions and ease of traceability for all kind of records.

Paperless quality system facilitates automate and streamline QMS processes, faster implementation, ensure regulatory compliance and improve.

LIMS adopted for supporting modern laboratory operations, automate the laboratory data management and improve the lab efficiency.

Computerized system used for store, manage, track electronic documents and ease of issuance archival, retrieval processes. It’s also ensure the long term security and availability of data.

Electronic training program for tracking, reporting, and delivery of training courses. LMS allows freedom for learning from anytime and anywhere.

Automated data acquisition from integrated devices throughout the operation for transparency, monitoring, and easy tracking of alarms and events.

Material Management

Input material for pharma product being as a key area for quality product, Akums follow same criteria for identifying and approving the vendors for manufacturing of consistent quality products. Input materials are sourced from national and international supplier and verified for assuring the quality of final product.

Each batch of raw materials undergoes rigorous testing for identity, purity, and quality before processing for manufacturing. Regular supplier audit conducted for evaluation and monitoring of supplier efficiency towards quality of raw materials. This proactive approach ensures that the materials we use are consistently of the highest quality, laying a strong foundation for maintaining quality of the final product.

Continious Development

Continuous development at Akums is driven by a robust culture of Learning & Development (L&D), fostering talent growth and innovation, coupled with cutting-edge Research & Development (R&D) initiatives. This is complemented by an unwavering commitment to quality, ensuring adherence to global standards and consistent product excellence.

Learning and Development
Research and Development
Quality Culture

Learning and Development

Continuous learning and training of employee is essential for delivering the quality products. Every employee, undergoes regular training to stay updated on the latest quality standards, regulatory changes, and technological advancements.

cGMP Training

Regular training provided to employees for updating them as per current regulatory requirement, pharmacopoeial updates etc.

Environment, Health and Safety (EHS) Training

EHS training provided for ensuring the employee health and safety at workplace.

Skill Development Centre

Skill Development Centre established for developing and shaping the employees to create of battery of trained pharma professionals.

Research and Development

Well equipped and highly qualified scientist engaged for Discovery and Development of potential drugs for optimizing the therapeutic approaches and addresses the unmet medical needs.

Dedicated R&D facilities established for APIs and different formulation for new inventions as well as improvement of existing ones.

Quality Culture

A quality culture developed for genuinely care about the quality of work, and make decisions based on achieving the level of quality product.

Quality culture developed across the organization for improved product quality, enhanced patient safety, regulatory compliance, person awareness etc.

Quality by Design (QbD) Approach

Akums embraces a Quality by Design (QbD) approach in product development and manufacturing. This approach emphasizes building quality into the product from the initial design stage rather than testing for quality at the end of production. Through QbD, we ensure that product characteristics, formulation, and process parameters are defined and controlled to guarantee consistent performance.

Critical Quality Attributes (CQA) identification to ensure that the product meets safety and efficacy standards.

Process Analytical Technology (PAT) to monitor and control manufacturing processes in real-time.

Risk assessment and management throughout the development process to mitigate potential quality issues before they arise.

Zero-Defect Mission

Our mission at Akums is to deliver zero defect products to satisfy the customer expectations. Every unit piece of product is meticulously manufactured to avoid defects, ensuring safety, efficacy, quality and reliability. With our continuous improvements in quality systems and a zero-tolerance policy towards non-compliance, Akums has built a reputation as a trusted partner that delivers products right the first time, every time.

Environmental and Safety Compliance

Environment and safety is integral to our organizational principles and core values. Akums is on a constant growth by follows stringent environmental regulations and practices to ensure minimum impact on natural resources and by creating a safe working culture with awareness on safety systems through participation of each employee.

Akums: A Trusted Partner for Quality You Can Rely On

Robust quality standards are applied to achieve the quality products which is efficacious and safest for patient health. The quality feature establish structured processes for continuous quality improvement.
We don’t believe on meet the minimum standards, we set the benchmark for excellence in the pharmaceutical and healthcare industries. Our clients trust us for delivering safe, efficacious, and reliable products that adhere to the highest quality standards at national and international level. Partner with us for quality you can trust, backed by years of expertise, innovation, and an unwavering commitment to excellence.