Our Certifications
ISO 9001:2015 – Quality Management System (QMS)
ISO 9001:2015 is an international standard developed by the International Organization for Standardization (ISO) that specifies the requirements for a Quality Management System (QMS). It is designed to help organizations of all types and sizes ensure that they consistently provide products and services that meet customer and regulatory requirements and aim to enhance customer satisfaction through effective system implementation.
The 2015 revision introduced a stronger emphasis on risk-based thinking, leadership involvement, and aligning quality management with broader business strategy. It follows a high-level structure (Annex SL) that makes it easier to integrate with other ISO management system standards, such as ISO 14001 (Environmental Management) or ISO 45001 (Occupational Health & Safety).
Key principles of ISO 9001:2015 include:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
Organizations certified to ISO 9001:2015 demonstrate their commitment to quality, continual improvement, and customer satisfaction. The standard does not prescribe specific processes but encourages a flexible, process-oriented approach to quality management tailored to each organization’s needs.
NMRA – National Medicines Regulatory Authority (Sri Lanka)
The National Medicines Regulatory Authority (NMRA) is the primary regulatory body in Sri Lanka responsible for ensuring the safety, efficacy, and quality of medicines, medical devices, and borderline products (such as cosmetics and nutraceuticals). Established under the NMRA Act No. 5 of 2015, the authority plays a critical role in protecting public health through the regulation and oversight of pharmaceuticals and related products in the country.
Key Functions of the NMRA:
Registration and Approval of medicinal products, medical devices, and other health-related items before they are marketed in Sri Lanka.
Licensing of manufacturers, importers, distributors, and pharmacies involved in the supply chain of pharmaceuticals.
Pharmacovigilance to monitor and manage adverse drug reactions and ensure ongoing product safety after approval.
Inspection and Enforcement to ensure compliance with good manufacturing, distribution, and pharmacy practices (GMP, GDP, GPP).
Laboratory Testing of medicines and medical devices to verify quality and conformity to standards.
Promoting Rational Use of medicines through public awareness and guidelines for healthcare professionals.
Mission and Vision:
Mission: To ensure access to safe, effective, and quality-assured medicinal products and medical devices for the Sri Lankan population.
Vision: To be a leading regulatory authority in the region, safeguarding public health through excellence in regulation and innovation.
The NMRA collaborates with global organizations such as the World Health Organization (WHO) and harmonizes with international regulatory best practices to strengthen the regulatory framework in Sri Lanka.
GMP – Good Manufacturing Practice
Good Manufacturing Practice (GMP) is a system that ensures products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in pharmaceutical and food production that cannot be eliminated through final product testing alone. GMP covers all aspects of production, from raw materials, premises, and equipment to the training and hygiene of staff.
GMP is a key part of quality assurance and is required by regulatory authorities around the world, including the World Health Organization (WHO), the U.S. FDA, the European Medicines Agency (EMA), and national bodies like Sri Lanka's NMRA. Compliance with GMP is mandatory for manufacturers of medicines, medical devices, food, and certain cosmetics.
Core Principles of GMP:
Hygienic conditions and clean manufacturing environments.
Clearly defined and validated processes that are consistently followed.
Documented procedures and records to demonstrate product quality and traceability.
Qualified personnel with appropriate training and responsibilities.
Proper maintenance of facilities and equipment to prevent contamination or errors.
Effective quality control throughout all stages of production.
Importance of GMP:
Protects consumer health and safety by ensuring product quality and reducing risks such as contamination, mix-ups, and deviations.
Ensures regulatory compliance and legal operation of manufacturing facilities.
Builds trust and credibility in pharmaceutical and food products.
Facilitates international trade, as GMP-compliant products are more likely to meet export requirements.
GMP is not a one-time certification but an ongoing commitment to quality. Continuous improvement, regular audits, and updates to practices in line with technological advances are essential to maintaining GMP compliance.
ISO 22716 – Good Manufacturing Practices (GMP) for Cosmetics
ISO 22716 is an international standard that provides guidelines for Good Manufacturing Practices (GMP) specifically for the cosmetic industry. Published by the International Organization for Standardization (ISO), it offers practical advice and a structured approach to managing the production, control, storage, and shipment of cosmetic products to ensure their quality and safety.
This standard is recognized globally and complements regulatory requirements in many countries. It bridges the gap between quality management systems and the specific needs of cosmetic manufacturing, helping organizations demonstrate their commitment to safe, high-quality products.
Key Elements of ISO 22716:
Personnel: Training and hygiene practices to ensure product safety.
Premises and Equipment: Proper layout, design, and maintenance to avoid contamination and ensure cleanliness.
Raw Materials and Packaging: Controls over the selection, receipt, storage, and handling of materials.
Production and In-Process Controls: Clear procedures to ensure consistency and compliance with product specifications.
Finished Product Control: Inspection, testing, and release procedures before distribution.
Quality Control and Documentation: Robust record-keeping, batch tracing, and documentation to maintain traceability and accountability.
Handling of Deviations and Complaints: Procedures for managing non-conformities, recalls, and customer complaints effectively.
Benefits of ISO 22716:
Ensures consumer safety by minimizing risks of contamination and variability.
Improves operational efficiency through standardized procedures.
Supports regulatory compliance with cosmetic laws and regulations in local and international markets.
Enhances marketability and global acceptance of cosmetic products.
Facilitates continual improvement through structured quality and risk management.
ISO 22716 is often used by cosmetic manufacturers, contract manufacturers, packagers, and distributors. It integrates well with ISO 9001 and helps build a comprehensive quality and compliance framework in the cosmetics industry.