ArticleActa bio-medica : Atenei Parmensis2019
The requirements for manufacturing highly active or sensitising drugs comparing Good Manufacturing Practices.
Article in Acta bio-medica : Atenei Parmensis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Artemisinin-Based Combination Therapies in East Africa: A Systematic Review of Quality, Clinical Efficacy, and Regulatory Progress Towards Sustainable Malaria Control.Tropical medicine & international health : TM & IH · 2026Pooled it
- Preventing Microorganism Contamination in Starting Active Materials for Synthesis from Global Regulatory Agencies: Overview for Public Health Implications.Microorganisms · 2025Review
- Chlorine Dioxide Dry Gas: A Promising Solution for Effective Decontamination of Cephalosporin Compounds.Applied biosafety : journal of the American Biological Safety Association · 2024Article
- Evaluation of environmental antibiotic contamination by surface wipe sampling in a large care centre.The Journal of antimicrobial chemotherapy · 2024Article
- Article
- Development and Validation for Quantification of Cephapirin and Ceftiofur by Ultraperformance Liquid Chromatography with Triple Quadrupole Mass Spectrometry.Molecules (Basel, Switzerland) · 2022Article
- Development and validation of a gas chromatography method for the determination of β-caryophyllene in clove extract and its application.Scientific reports · 2021Article
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo date there exist no internationally recognised Good Manufacturing Practices (GMP) that clearly outline universally accepted standards for manufacturing highly active or sensitising ingredients. The pharmaceutical industry is faced with a twofold problem: determining which drugs need dedicated production areas and identifying the different regulations required in different countries. The aim of this paper is to find, by comparing the current regulations of the various Regulatory Agencies, the differences between containment requirements for the production of highly active or sensitising ingredients.
methodsAn analysis of the following Regulatory Agencies' GMPs was performed: Europe (EMA), China (CFDA), Mexico (COFEPRIS), United States (FDA), Canada (Health Canada) Brazil (ANVISA), India (CDSCO), PIC/S and WHO in order to examine the differences in terms of containment requirements set by the different Regulatory Authorities for the manufacture of highly active or sensitising ingredients.
resultsOur analysis found that the majority of Regulatory Agencies require that beta-lactams (sensitising materials) be produced in dedicated and segregated facilities. For "certain" highly active pharmaceutical ingredients (APIs), COFEPRIS, FDA, HC, EMA, PIC/S and WHO require that they be produced in facilities similar to those required for beta-lactams, while CDSCO, CFDA and ANVISA require that production takes place in segregated areas. Further differences between the Agencies have emerged regarding classes of highly APIs that require dedicated production.
conclusionA study of GMP adopted by Regulatory Agencies has uncovered significant differences, in particular concerning containment requirements for the production of APIs. For this reason, the harmonisation of GMP following up-to-date quality standards based on cutting-edge science which are globally applicable is fundamental and will benefit companies and patients alike. Pharmaceutical companies would not be obliged to follow requirements enforced by the State in which they intend to manufacture a product, and patients would benefit from high-quality drugs regardless of their place of production.
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