CERTIFIKÁT SVP PRO VÝROBCE

Importance of the topic

Good Manufacturing Practice (GMP) certification of control laboratories is a cornerstone of pharmaceutical quality assurance. A validated, inspected control laboratory provides legally defensible analytical results for release testing, stability studies and import controls. Confirmation of compliance with EU GMP and WHO recommendations increases regulatory confidence, reduces supply-chain risk and supports safe patient access to medicines.

Objectives and overview

This document summarizes a GMP compliance certificate issued by the Czech competent authority for the control laboratory located at Palacký University in Olomouc (Department of Analytical Chemistry, RCPTM). The certificate confirms that, based on the inspection carried out on 14 September 2023, the laboratory meets the principles and guidelines of Good Manufacturing Practice as set out in Directive (EU) 2017/1572 and related national legislation. The site is authorised to perform chemical and physical quality control testing relevant to both manufacturing operations and the importation of human medicinal products.

• Certified entity: Palacký University in Olomouc, Department of Analytical Chemistry, RCPTM (rooms 228, 324, 325, 326), Šlechtitelů 27, 783 71 Olomouc.
• Control laboratory authorisation reference: sukls152628/2014 (last variation sukls150378/2017 issued 26.06.2017).
• GMP Certificate reference: sukls164869/2023, date of issue: 17.10.2023.

Methodology and inspection details

The certificate results from a planned inspection conducted under the national inspection programme in line with EU pharmaceutical directives and Czech national law. Relevant legal bases cited include provisions of Directive 2001/83/EC (including inspections under Art. 111(5) and Art. 40 as transposed) and national provisions of Act No. 378/2007 Coll. The inspection evaluated the site’s quality systems, test methods and compliance with the GMP principles and guidelines embodied in Directive (EU) 2017/1572 and WHO recommendations for Good Practices.
Key procedural points recorded in the certificate:

• Inspection date: 14.09.2023.
• Certificate issue date: 17.10.2023.
• Scope declared: chemical/physical testing within quality control for manufacturing operations and quality control testing of imported human medicinal products.
• Verification: the certificate’s authenticity may be checked in the EudraGMDP database; the certificate is valid only if all pages and both Parts 1 and 2 are presented together.
• Validity caveat: the certificate reflects the site status at the time of inspection and should not be assumed to remain current after more than three years unless updated by regulatory entries (restrictions or clarifying remarks).

Main findings and discussion

The inspecting authority concluded that the control laboratory complies with relevant GMP principles and guidelines. No specific restrictions or clarifying remarks regarding the scope were listed on the certificate. The assessment indicates that the laboratory’s organisational controls, documented procedures and testing capability for chemical and physical analyses meet expectations for a control laboratory servicing pharmaceutical manufacturing and import controls.
Practical implications of the findings include the laboratory’s formal recognition for performing QC testing required by manufacturers and importers of human medicinal products, and regulatory acceptance of its role in ensuring product quality and safety.

Benefits and practical applications

• Regulatory acceptance: the certificate supports use of the laboratory’s data in regulatory submissions and batch release activities.
• Supply-chain assurance: certified QC capability reduces regulatory risk for manufacturers and importers relying on external testing.
• Quality governance: certification indicates robust quality management, method validation, documentation and personnel competence aligned with EU and WHO expectations.

Future trends and potential uses

Looking forward, maintaining and extending compliance will increasingly rely on risk-based regulatory oversight, digital recordkeeping, data integrity controls and advanced analytical technologies. Opportunities and trends include:

• Broader adoption of digital laboratory information management systems and electronic batch records to strengthen traceability and data integrity.
• Implementation of risk-based approaches to focus inspections and quality resources where they most impact patient safety.
• Expansion of testing scope to include advanced impurity profiling, high-resolution mass spectrometry and orthogonal physical methods as industry needs evolve.
• Continuous training and competency programs to address evolving regulatory expectations and new analytical workflows.

Conclusion

The certificate confirms that the Palacký University RCPTM analytical control laboratory met EU GMP principles at the time of inspection (14.09.2023) and was formally certified on 17.10.2023 (GMP Certificate sukls164869/2023). The laboratory is authorised to perform chemical and physical quality control testing for manufacturing operations and the importation of human medicinal products. Users of the certificate should verify authenticity via the appropriate regulatory database and note that the certificate reflects the site status at the inspection date and may be subject to change.

References

• State Institute for Drug Control (SÚKL). GMP Certificate sukls164869/2023; issued 17 October 2023. Authorised person: Eva Niklíčková, Director of the Inspection Department.