Quality Assurance Policy
Washington D.C., October 2025
Quality Assurance Policy for Pharmaceuticals and Medical Devices
Version: 1.2 – October 2025
1. Purpose:
This policy establishes DKT International’s Quality Assurance (QA) commitment to ensuring the safety, quality, and efficacy of all pharmaceutical contraceptives, reproductive health commodities, and medical devices we procure, distribute, and sell. It provides a structured framework for risk-based quality assurance across the product lifecycle, thereby protecting users, strengthening trust, and aligning with international best practices.
This policy also establishes governance, escalation pathways, and a framework for continuous improvement, ensuring that our quality assurance system is auditable, accountable, and aligned with international standards.
2. Scope:
This policy applies to:
2.1. All pharmaceutical contraceptives (oral contraceptives, injectables, implants, emergency contraception, and others).
2.2. Reproductive health products (including misoprostol, mifepristone, and sexually transmitted infection treatments).
2.3. Medical devices (condoms, intrauterine devices, pregnancy tests, menstrual cups, syringes, and others).
2.4. All stages of the supply chain: procurement, manufacturing oversight, storage, distribution, and post-market surveillance.
3. Guiding Principles:
3.1. Regulatory Compliance: Products must comply with one or more of the following: a Stringent Regulatory Authority, World Health Organization (WHO) Prequalification, Pharmaceutical Inspection Co-operation Scheme PiCS), or the National Medical Regulatory Authority (NRMA) requirements.
3.2. Risk-Based Quality Assurance: Quality assurance interventions are scaled to product risk, supply chain vulnerabilities, and end-user safety implications.
3.3. Transparency and Accountability: All quality assurance processes must be documented and reviewed. Reports will be sent to DKT Headquarters as needed.
3.4. Continuous Improvement: Quality assurance practices evolve alongside global best practices and regulatory frameworks.
3.5. Documented Governance: All policies, procedures, and supporting documentation must be version controlled, reviewed periodically, and approved by designated leadership.
4. Quality Control at DKT:
Quality control is part of DKT International’s risk mitigation approach to ensure the safety and quality of our products. This approach outlines the steps that DKT International takes in the markets where we work, and how we interact with international manufacturers and suppliers. Together, these efforts provide confidence that DKT products are safe and effective for use.
The DKT Approach to Supplier Quality Control
4.1. Know Your Supplier:
4.1.1. All pharmaceutical manufacturers and suppliers must hold valid current Good Manufacturing Practice certification (GMP), issued by one of the following: a Stringent Regulatory Authority, PiCS – Pharmaceutical Inspection Co- operation Scheme, World Health Organization Prequalification or their NMRA – National Medical Regulatory Authorities. This is the baseline requirement for supplier qualification.
4.1.2. DKT International works with dozens of manufacturers and suppliers worldwide, with diversification across Asia, Africa, Europe, and Latin America to mitigate risk.
4.1.3. Supplier relationships are built as long-term strategic partnerships. Short-term, transactional engagements that prioritize cost savings over quality are avoided.
4.2. Supplier Assessment:
4.2.1. Suppliers are assessed through dossier review, inspections/on site visits, audits and continual contract monitoring by qualified experts with extensive experience in pharmaceutical manufacturing and quality assurance. These professionals typically include pharmacists, chemists, and quality management specialists trained in Good Manufacturing Practices (GMP), ISO quality systems, and regulatory compliance. Their evaluations encompass all critical aspects of production, quality control, documentation, and supply chain integrity to ensure that products consistently meet DKT’s standards for safety, efficacy, and reliability.
4.2.2. Re-assessments may be required depending on risk, product type, or findings from post-market surveillance.
4.3. Independent Audits and Inspections:
4.3.1. As appropriate, DKT International will commission an independent third-party audits of manufacturing sites to verify compliance with Good Manufacturing Practices.
4.3.2. Audits must include assessment of data integrity, supply chain security, and corrective action follow-up.
4.4. Supplier Performance Monitoring:
4.4.1. Supplier performance is reviewed regularly against defined key performance indicators, including complaint rates, on-time delivery, batch rejection rates, and closure of corrective actions.
4.5. Continuous Oversight and Improvement:
4.5.1. DKT International reviews supplier performance regularly and requires corrective actions where deficiencies are found.
5. Governmental (National) Regulatory Oversight in the Markets We Serve:
5.1.1. DKT International works closely with national regulatory authorities in both manufacturing and importing countries. Products must meet national requirements and quality standards to be registered and distributed.
5.2. Regulatory submissions include full product dossiers including certifications, manufacturing, clinical and quality, production and site information as per local requirements.
5.3. National authorities, such as Ministries of Health or national FDAs, may conduct their own inspections. DKT International supports and cooperates fully with these efforts.
5.4. Clinical trials for safety and efficacy are conducted by manufacturers as part of product registration dossiers; governments review this evidence rather than conducting their own post-import trials. DKT International supports and cooperates fully with these efforts.
6. Product Testing and Independent Verification:
6.1. All products must undergo in-house manufacturer testing prior to release.
6.2. DKT International commissions independent, third-party testing at accredited laboratories to verify compliance with technical specifications and pharmacopeial standards as needed.
6.3. Batch Testing: generic pharmaceuticals and medical devices will be periodically independently tested in a WHO-prequalified, SRA-accredited, or equivalent-approved laboratory on a regular basis to ensure molecule to market GMP/ GLP/ GCP compliance and product efficacy. Such testing may include but is not limited to:
6.3.1. Analytical testing to check for identity, assay (potency), disintegration/dissolution, residual solvents;
6.3.2. Microbiological Testing such as microbial limit testing, sterility, and biocompatibility assessments.
7. Pharmacovigilance and Post-Marketing Surveillance:
7.1. DKT International maintains a pharmacovigilance policy with systems for reporting, investigating, and escalating adverse events according to local regulations.
7.2. Manufacturers and suppliers are required to maintain their own pharmacovigilance systems and to share adverse event and post-marketing surveillance data with DKT.
7.3. DKT also audits the implementation of QA and pharmacovigilance policies through its internal quality team, ensuring compliance in practice.
7.4. Related policies cover warehousing, supply chain operations, and product testing.
8. Warehousing and Distribution Quality Assurance
8.1. Ensuring the integrity of pharmaceutical contraceptives, reproductive health products, and medical devices requires robust warehousing and distribution practices. DKT and third-party storage facilities and distribution partners must comply with local regulations regarding goods storage and distribution practices to maintain product quality throughout the supply chain. Leaders and managers are responsible for ensuring that storage environments meet specifications for temperature, humidity, cleanliness, and security, and that products are handled in a way that prevents damage, contamination, or theft.
8.2. Temperature-sensitive products must be monitored using calibrated equipment and continuous data loggers, with corrective actions documented in case of deviations. Warehouses should apply first-expiry, first-out (FEFO) principles, maintain clear segregation of quarantined or recalled stock, and conduct routine inspections of stock condition and packaging integrity.
8.3. During transport, products must be protected from extreme temperatures, physical damage, and diversion risks. DKT local teams and contractors should ensure that the products reaching end users are of the same safety and quality as when they left the manufacturer.
9. Risk Mitigation Framework
9.1. Preventive: Supplier qualification, audits, regulatory compliance, and batch testing.
9.2. Detective: Ongoing surveillance, independent testing, incident investigations.
9.3. Corrective: Product recalls, supplier delisting, policy updates, staff retraining, and corrective and preventive actions.
10. Roles and Responsibilities
10.1. Global Quality Assurance Team: Owns this policy, oversees suppliers, performs audits, and manages global risk assessments.
10.2. Country Offices: Ensure compliance with national regulations, conduct post- market surveillance and monitoring, and report adverse events.
10.3. Suppliers and Manufacturers: Comply with all contractual requirements, good manufacturing practices, and pharmacovigilance obligations.
10.4. Executive Management: Reviews and approves policy updates, and ensures sufficient resources are allocated.
11. Training and Capacity Building
11.1. All staff involved in procurement, quality assurance, warehousing, and distribution must receive role-specific training.
11.2. Internal and external auditors must meet qualification requirements.
11.3. Refresher training must be provided regularly as standards evolve.