To provide comprehensive consultancy and auditing services to Glosarij KS, a pharmaceutical wholesale company representing MSD, to establish, implement, and ensure compliance with an integrated Quality Management System (QMS) aligned with ISO 9001 and Good Distribution Practices (GDP). This aimed to meet the stringent requirements of both international standards and a key pharmaceutical partner.
Year
November 2023-March 2025
Country
Kosova
Type of Activity
Pharmaceutical Quality Management System (QMS) Consulting; Good Distribution Practices (GDP) Compliance Consulting; Regulatory Affairs Consulting (focused on GDP)
Auditing Services; Training and Development (QMS & GDP); Certification Support Consulting (ISO 9001 & GDP)
Activities:
Engineered and deployed a comprehensive Integrated Management System framework, aligning it precisely with ISO 9001 and GDP.
Designed and implemented a robust document management system that rigorously met the requirements of both standards (policies, SOPs, programs, work instructions, etc.).
Conducted thorough risk assessments to pinpoint and evaluate potential threats to pharmaceutical product quality and safety.
Developed and implemented meticulously defined processes for product storage, handling, distribution, and recall, integrating specific cold chain management protocols for thermolabile medicinal products.
Delivered comprehensive training programs to Glosarij KS staff, equipping them with in-depth knowledge of QMS and GDP principles and their practical application.
Conducted regular internal audits to assess the level of compliance with ISO 9001 and GDP standards across all relevant operations.
Established and managed a proactive system that identified, documented, investigated, and resolved non-conformities through effective corrective and preventive actions.
Provided dedicated support and expert guidance to the Glosarij KS team, ensuring their readiness for the second-party audit conducted by MSD.
Provided dedicated support and expert guidance to the Glosarij KS team, facilitating their successful navigation of the certification audit conducted by Bureau Veritas.
Results:
Achieved a successful second-party audit by MSD, validating adherence to their stringent quality expectations.
Secured ISO 9001 and GDP certification from Bureau Veritas, attaining formal recognition of adherence to international standards.
Empowered staff with the necessary knowledge and skills through targeted training, fostering a culture of quality and compliance.
Bolstered credibility and trust with partners, clients, and regulatory authorities, enhancing the company’s reputation.