EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

2019 ◽  
pp. 93-108 ◽  
Author(s):  
Sarfaraz K. Niazi
Keyword(s):  
Good Manufacturing Practice ◽  
Medicinal Products

scholarly journals Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Mariele Viganò ◽  
Silvia Budelli ◽  
Cristiana Lavazza ◽  
Tiziana Montemurro ◽  
Elisa Montelatici ◽  
...  
Keyword(s):  
Analytical Methods ◽  
Cellular Therapy ◽  
Good Manufacturing Practice ◽  
New Drugs ◽  
Medicinal Products ◽  
Biologic Drugs ◽  
Sterility Testing ◽  
Lack Of Information ◽  
Advanced Therapy ◽  
Experimental Use

Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules. Despite their classification as medicinal products is already well recognized, there is still a lack of information and indications to validate methods and to adapt the noncompendial and compendial methods to these peculiar biological products with intrinsic characteristics that differentiate them from classic synthetic or biologic drugs. In the present paper, we present the results of the validation studies performed in the context of MSC development as ATMPs for clinical experimental use. Specifically, we describe the validation policies followed for sterility testing, endotoxins, adventitious viruses, cell count, and immunophenotyping. Our work demonstrates that it is possible to fully validate analytical methods also for ATMPs and that a risk-based approach can fill the gap between the prescription of the available guidelines shaped on traditional medicinal products and the peculiar characteristics of these novel and extremely promising new drugs.

scholarly journals Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities

2010 ◽  
Vol 61 (4) ◽  
pp. 425-436 ◽  
Author(s):  
Siniša Tomić ◽  
Anita Sučić ◽  
Adrijana Martinac
Keyword(s):  
Regulatory Network ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Product ◽  
Vital Role ◽  
Medicinal Products ◽  
Eu Member States ◽  
Eu Membership ◽  
European Regulatory ◽  
The Eu

Good Manufacturing Practice: The Role of Local Manufacturers and Competent AuthoritiesIn every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment.

scholarly journals Measures to minimize cross-contamination risks in Advanced Therapy Medicinal Product manufacturing

2014 ◽  
Author(s):  
Livia Roseti ◽  
Marta Serra ◽  
Brunella Grigolo
Keyword(s):  
Medicinal Product ◽  
Main Product ◽  
Good Manufacturing Practice ◽  
Cross Contamination ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Product ◽  
Advanced Therapy ◽  
European Regulations ◽  
Product Manufacturing

Current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. These quality requirements are generally thought to be elaborate and costly. However they ensure three main product characteristics: safety, consistency and absence of cross-contamination. The term cross-contamination is used to indicate misidentification of one cell line or culture by another. The Good Manufacturing Practice Guidelines suggest some recommendations in order to prevent cross-contaminations and require a demonstration that the implemented actions are effective. Here we report some practical examples useful both to minimize cross-contamination risks in an Advanced Therapy Medicinal Product production process and to evaluate the efficacy of the adopted measures.

scholarly journals Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1282
Author(s):  
Silvia Berisa-Prado ◽  
Natalia Vázquez ◽  
Manuel Chacón ◽  
Mairobi Persinal-Medina ◽  
Sergio Alonso-Alonso ◽  
...  
Keyword(s):  
Corneal Epithelium ◽  
Good Manufacturing Practice ◽  
Working Environment ◽  
Small Scale ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Products ◽  
Class D ◽  
Work Area ◽  
Advanced Therapy ◽  
Class B

Among several requirements for the manufacture of Advanced Therapy Medicinal Products (ATMP) are: following the guidelines of a pharmaceutical quality system, complying with Good Manufacturing Practice (GMP) and access to a cleanroom fulfilling strict environmental conditions (Class A work area and Class B environment). This makes ATMP expensive. Moreover, the production of many of these therapeutic products may also be unprofitable, as in most cases their use is limited to a few patients and to a single batch per manufacturing unit. To reduce costs, ATMP may be produced in a scaled-down system isolated from the external environment (isolator), allowing for placement of this facility in a Class D environment, which is much more permissive and less costly. In this work, we confirm that it is possible to manufacture bioengineered corneal epithelium inside an isolator while fulfilling all the safety assurance standards at an affordable cost for patients. This small-scale ultra-clean working environment complies with GMP guidelines and could be a solution for the high costs associated with conventional cleanroom ATMP production.

scholarly journals Good Manufacturing Practice for Medicinal Products in Bulgaria: an Analysis of Regulatory Inspection Findings

Folia Medica ◽  
2020 ◽  
Vol 62 (1) ◽  
pp. 165-171
Author(s):  
Assena H. Stoimenova ◽  
Bogdan J. Kirilov ◽  
Stanislav R. Gueorguiev ◽  
Elina S. Petkova-Gueorguieva ◽  
Sava G. Ognianov
Keyword(s):  
Good Manufacturing Practice ◽  
Regulatory Agencies ◽  
European Economic Area ◽  
Medicinal Products ◽  
Eu Member States ◽  
Economic Area ◽  
Drug Agency ◽  
Human Use ◽  
National Competent Authorities

Background: The manufacture of medicinal products for human use in the European Economic Area is governed by European Directives and Regulations stipulating the relevant principles and guidelines of Good Manufacturing Practice, describing the minimum standard to be fulfilled in the production processes.   Aim: To present analysis of the deficiencies reported following Good Manufacturing Practice inspections in Bulgaria in two consecutive years (2016, 2017) and to compare them with results from similar inspections reported by other EU member states.   Materials and methods: A retrospective study was carried out by reviewing the complete Good Manufacturing Practice inspection reports of all manufacturers conducted by the Bulgarian Drug Agency in 2016 and 2017, according to relevant requirements and applicable local legislation. The items reviewed were scope of inspection, type of companies, classification of deficiencies – ‘critical’, ‘major’ and ‘other significant deficiencies’, their nature and reference to EU Good Manufacturing Practice.   Results: The analyzed data included 55 inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major. Twenty inspections were performed in 2016 vs. 35 inspections in 2017. The pattern of deficiencies was similar to the findings of other EU regulatory agencies, showing that equivalent requirements were applied. Our analysis showed that Bulgarian Drug Agency inspectors rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel and Qualification of Suppliers unlike other EU regulators agents.   Conclusions: Our analysis of Good Manufacturing Practice inspection findings in 2016 and 2017 showed that the Bulgarian Drug Agency demonstrated its ability to detect non-compliances and take necessary regulatory actions. Quality related issues constitute the main reasons for non-compliances with the requirements. Publishing the results from the inspections performed by the national competent authorities enhances the regulatory transparency that can be useful for industry to improve its Good Manufacturing Practice compliance.

Sign in / Sign up

Export Citation Format

Share Document