scholarly journals Cross contamination control strategy in multiproduct pharmaceutical manufacturing facilities

2020 ◽  
Vol 66 (03) ◽  
pp. 117-118
Author(s):  
Viktorija Velkovska ◽  
Meri Davcheva ◽  
Milkica Gligorova
Keyword(s):  
Control Strategy ◽  
Pharmaceutical Manufacturing ◽  
Cross Contamination ◽  
Contamination Control ◽  
Manufacturing Facilities

A Contamination Control Strategy Gone Wrong

2021 ◽  
Vol 25 (5) ◽  
Author(s):  
Jeanne Moldenhauer
Keyword(s):  
Control Strategy ◽  
Control Strategies ◽  
Pharmaceutical Manufacturing ◽  
Production Facility ◽  
Vaccine Production ◽  
Contamination Control

Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. Starting with the updates to the European Union’s Annex 1 for the Manufacture of Sterile Drugs there has been an increased focus on contamination control strategies in facilities. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a series of observations for a vaccine production facility and how we might learn from these observations. Highlighted are some of the contamination control issues. The FDA 483 Report was published in redacted form.

scholarly journals Gluten-Free Diet: From Development to Assessment of a Check-List Designed for the Prevention of Gluten Cross-Contamination in Food Services

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1274 ◽  
Author(s):  
Priscila Farage ◽  
Renata Puppin Zandonadi ◽  
Verônica Cortez Ginani ◽  
Lenora Gandolfi ◽  
Eduardo Yoshio Nakano ◽  
...  
Keyword(s):  
Internal Consistency ◽  
Food Contamination ◽  
Free Food ◽  
Cross Contamination ◽  
Gluten Free ◽  
Food Services ◽  
Check List ◽  
Contamination Control ◽  
Control Instrument ◽  
Classification Score

Gluten cross-contamination in gluten-free food may jeopardize treatment of celiac patients. Considering the deficit of appropriate instruments to enable the implementation of safe production practices for gluten-free food, this study aimed to evaluate the application of a check-list elaborated for gluten cross-contamination prevention in food services. The instrument was applied in 60 Brazilian food services. Interobserver reproducibility and internal consistency of the check-list were tested. A score classification was created for establishments according to the food contamination risk assessment. Subsequent to the application and statistical analysis, the original instrument was reduced to a 30-item check-list. In the reproducibility analysis, none of the 30 items showed significant divergence among the evaluators (p > 0.05 in the Cochran Q test). The 30-item version of the check-list presented Kuder–Richardson Formula 20 (KR-20) = 0.771, indicating good internal consistency. The proposed classification score is obtained by adding 1 point for each item with an “adequate” response; therefore, the final score may vary between 0 and 30 points. Establishments with up to 15 points exhibit risk of gluten contamination, while establishments with a score above 16 points exhibit low risk of contamination. The check-list displayed good reproducibility and internal consistency, suggesting that it could be a useful gluten contamination control instrument in food services.

Challenges in setting Permitted Daily Exposure (PDE) Limits for pharmaceuticals: A review

2021 ◽  
pp. 1-16
Author(s):  
Varun Ahuja ◽  
Mohan Krishnappa
Keyword(s):  
Drug Product ◽  
Relevant Literature ◽  
Pharmaceutical Manufacturing ◽  
Data Driven ◽  
Cross Contamination ◽  
Daily Exposure ◽  
Risk Assessor ◽  
Carry Over ◽  
Pde Methods ◽  
The Given

BACKGROUND: When more than one drug is manufactured at a shared facility or equipment in pharmaceutical manufacturing, the potential carry-over of the retained residue of existing drug product on product contact parts of the equipment to the next product can be a source of cross contamination. Permitted daily exposure (PDE) is derived based on the complete nonclinical and clinical data available and is a dose that is unlikely to cause adverse effects if an individual is exposed, by any route, at or below this dose every day over a lifetime. OBJECTIVE: The objective was to present a comprehensive review of available scientific knowledge for derivation of PDE. METHODS: PubMed and ScienceDirect databases were searched using keywords “PDE” and “pharmaceuticals” and all the relevant literature up to March 2021 was reviewed. We have also calculated PDEs for Tobramycin (CAS No. 32986-56-4) and Acetyl Salicylic Acid (ASA, CAS No. 50-78-2). RESULTS: This research will be useful for scientists working in the PDE domain. The given examples emphasize the importance of use of human data in calculating PDE. CONCLUSION: The duty of the risk assessor entrusted with setting PDEs is to derive a data driven, scientifically justified value that is safe for patients, while avoiding unjustified conservativeness that puts unnecessary burden on manufacturing.

scholarly journals Cross-Contamination as a Problem in Collection and Analysis of Environmental Samples Containing Microplastics—A Review

2021 ◽  
Vol 13 (21) ◽  
pp. 12123
Author(s):  
Aleksandra Bogdanowicz ◽  
Monika Zubrowska-Sudol ◽  
Andrzej Krasinski ◽  
Miroslaw Sudol
Keyword(s):  
Environmental Samples ◽  
Significant Problem ◽  
Correct Identification ◽  
Cross Contamination ◽  
Contamination Control ◽  
Potential Sources ◽  
Comprehensive Manner ◽  
Mitigation Methods ◽  
Inherent Part

Research conducted so far on the presence of microplastics in the environment shows that these items are ubiquitous pollutants and therefore constitute an inherent part of our lives. This constitutes a significant problem in many aspects, and one of them is the correct identification of microplastics in environmental samples. Environmental samples can be easily contaminated by plastic microparticles from other sources if proper precautions are not taken during sampling and analysis. The consequence of not taking this cross-contamination into account when analysing the results may be their significant overestimation. This review aims to draw attention to the problem of cross-contamination that accompanies the collection and analysis of samples for the presence of microplastics, and to discuss this issue in a comprehensive manner. The article indicates potential sources of cross-contamination, lists the mitigation methods, and describes the possibilities of assessing this type of contamination. Moreover, the review examines how cross-contamination control appears in practice, based on the available literature data.

scholarly journals Insight into the New EU GMP Annex 1

2021 ◽  
Author(s):  
Frank Panofen, ◽  
Daniele Pandolfi ◽  
Maurizio Della Pietra ◽  
Anna Campanella ◽  
Giulia Artalli ◽  
...  
Keyword(s):  
Risk Management ◽  
Control Strategy ◽  
Successful Implementation ◽  
Contamination Control ◽  
Analysis Process ◽  
Process Understanding ◽  
Management Concepts ◽  
Clear Differentiation ◽  
Insight Into ◽  
The Eu

The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. The contamination control strategy and its dependence on trend analysis, process understanding, thorough investigation, and a commitment to progress is now an essential activity referenced multiple times through the document. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are critical to successful implementation of system controls.

Implementing Project Portfolio Management at Pharmaceutical Manufacturing Facilities

2021 ◽  
Vol 5 (2) ◽  
pp. 36-48
Author(s):  
Kiran Kumar Kumar Chereddy ◽  
Simon Cleveland
Keyword(s):  
Portfolio Management ◽  
Poor Performance ◽  
The Body ◽  
Production Costs ◽  
Pharmaceutical Manufacturing ◽  
Project Portfolio ◽  
Project Portfolio Management ◽  
Screening Process ◽  
Screening Criteria ◽  
Manufacturing Facilities

Pharmaceutical manufacturing facilities are complex entities that are heavily regulated by health authorities. Manufacturing sites are challenged by increased production costs, tight regulations, and heavy competition. Without a disciplined and organized management of initiatives, projects end up being terminated due to poor performance or misalignment with strategy. This study examines different types of project needs at regulated manufacturing facilities and determines how the project portfolio management processes aids the manufacturing facilities in screening and selecting projects that aid in achieving the organization's strategic goals. Moreover, the study finds not one set of criteria can fit all projects in pharmaceutical manufacturing facilities. As a result, segregation of projects into different categories and then applying funds allocation ratio and the pre-screening criteria is proposed. Finally, the study contributes new logic inputs to the screening process within the body of the program and portfolio management.

Sign in / Sign up

Export Citation Format

Share Document