scholarly journals The application of cleaning validation principles on dietary supplements production equipment

2017 ◽  
pp. 141-153
Author(s):  
Davor Korcok ◽  
Nada Trsic-Milanovic
Keyword(s):  
Dietary Supplements ◽  
Microbial Growth ◽  
Good Manufacturing Practice ◽  
Production Equipment ◽  
Cleaning Validation ◽  
The Status ◽  
Cleaning Methods ◽  
Solid Form ◽  
Pharmaceutical Production ◽  
Microbiological Analyses

Cleaning validation for pharmaceutical production equipment is a documented proof of the efficient cleaning, and one of prerequisites of good manufacturing practice in medicine production. Successful validation confirms the efficiency of the procedures of cleaning, washing, and disinfecting of the manufacturing equipment, and records results of the chemical and microbiological analyses, which are a prerequisite for a safe final dietary product. The main goal of this study was to improve the cleaning process of the production equipment by using cleaning validation procedures on the solid form production line (capsules) in the Abela Pharm d.o.o. The validation principles that are used in manufacturing of medicines can be applied to determine more efficient cleaning methods that will ensure longer periods of the status clean in the production of dietary supplements. The outcome is a practical analysis of the production equipment in view of regulatory demands, confirming that the cleaning validation measures ensure prevention of unwanted microbial growth or removal of contamination from the production equipment in order to preserve the activity, efficacy, and safety of the final dietary product.

scholarly journals Intra-Laboratory Validation of Alpha-Galactosidase Activity Measurement in Dietary Supplements

Molecules ◽  
2021 ◽  
Vol 26 (6) ◽  
pp. 1566
Author(s):  
Elena Fabris ◽  
Michela Bulfoni ◽  
Alessandro Nencioni ◽  
Emanuele Nencioni
Keyword(s):  
Dietary Supplements ◽  
Good Manufacturing Practice ◽  
Activity Measurement ◽  
Intermediate Precision ◽  
Method Performance ◽  
Intestinal Gas ◽  
Technical Requirements ◽  
Ich Guidelines ◽  
Alpha Galactosidase

Introduction: Alpha-galactosidase (α-Gal) is an enzyme responsible for the hydrolyzation of glycolipids and glycoprotein commonly found in dietary sources. More than 20% of the general population suffers from abdominal pain or discomfort caused by intestinal gas and by indigested or partially digested food residuals. Therefore, α-Gal is used in dietary supplements to reduce intestinal gases and help complex food digestion. Marketed enzyme-containing dietary supplements must be produced in accordance with the Food and Drug Administration (FDA) regulations for Current Good Manufacturing Practice (cGMPs). Aim: in this work we illustrated the process used to develop and validate a spectrophotometric enzymatic assay for α-Gal activity quantification in dietary supplements. Methods: The validation workflow included an initial statistical-phase optimization of materials, reagents, and conditions, and subsequently a comparative study with another fluorimetric assay. A final validation of method performance in terms of specificity, linearity, accuracy, intermediate-precision repeatability, and system precision was then executed. Results and conclusions: The proven method achieved good performance in the quantitative determination of α-Gal activity in commercial food supplements in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals (ICH) guidelines and is suitable as a rapid in-house quality control test.

scholarly journals A Non-targeted Approach to Chemical Discrimination Between Green Tea Dietary Supplements and Green Tea Leaves by HPLC/MS

2011 ◽  
Vol 94 (2) ◽  
pp. 487-497 ◽  
Author(s):  
Jianghao Sun ◽  
Pei Chen ◽  
Long-Ze Lin ◽  
James M Harnly
Keyword(s):  
Dietary Supplements ◽  
Green Tea ◽  
Similarity Coefficients ◽  
Tea Leaves ◽  
Liquid Form ◽  
Epicatechin Gallate ◽  
Accurate Mass Measurements ◽  
Chemical Discrimination ◽  
Green Tea Leaves ◽  
Solid Form

Abstract Green tea-based dietary supplements (GTDSs) have gained popularity in the U.S. market in recent years. This study evaluated the phytochemical composition difference of GTDS in comparison with green tea leaves using an HPLC/MS fingerprinting technique coupled with chemometric analysis. Five components that are most responsible for class separation among samples were identified as (-) epicatechin gallate, strictinin, trigalloylglucose, quercetin-3-O-glucosylrhamnosylglucoside, and kaempferol-3-O-galactosyl-rhamnosylglucoside, according to the accurate mass measurements and MS/MS data. The similarity coefficients between the GTDSs in solid form with green tea were 0.55 to 0.91, while for the GTDSs in liquid form they were 0.12 to 0.89, which suggested that chemical composition variance across the GTDSs was significant. Flavonol aglycone concentrations were higher in GTDSs than in tea leaves, indicating the degradation of flavonol glycosides or the oxidation of catechin during the manufacturing and storage processes. In some GTDS samples, compounds were identified that were on the label. The results demonstrate the urgency of QC for GTDS products.

scholarly journals Characteristics of Drug and Dietary Supplement Inquiries by College Athletes

2009 ◽  
Vol 2 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Peter J. Ambrose ◽  
Candy Tsourounis ◽  
Rachel Olander ◽  
Frank Uryasz
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Testing ◽  
National Collegiate Athletic Association ◽  
The United States ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
The Status ◽  
Other Substances ◽  
Drug Free

Background: In the United States, the National Center for Drug Free Sport manages the drug-testing programs for athletes of the National Collegiate Athletic Association (NCAA). Through its Resource Exchange Center (REC), Drug Free Sport supports athletic staff and athletes with information regarding drugs and dietary supplements. Purpose: To characterize the types of drug-related and dietary supplement–related inquiries submitted to Drug Free Sport through the REC. Study Design: Cross-sectional study. Methods: All inquiries submitted to the REC for the period of September 1, 2005, through June 30, 2006, were reviewed. The data were categorized by the method of inquiry submission; the name of the substance in question; the sex, sport, and NCAA division of the athlete involved; the nature of the inquiry; and the response provided by the REC regarding the NCAA’s status of the substance in question. Results: Pseudoephedrine, acetaminophen/hydrocodone, and albuterol were the most commonly self-searched medications; stimulants accounted for the majority of banned medications. Dietary supplements accounted for 80% of all inquiries submitted to the REC via the Banned Drug Inquiry Form. Among all dietary supplements, creatine was the most commonly inquired. Banned substances accounted for 29% of all inquiries. Conclusions: There were more than 10 000 inquiries regarding the status of medications, dietary supplements, and other substances for NCAA athletes during the 2005–2006 academic year. It is helpful for athletes to have resources that help them navigate banned-substance lists and so avoid the inadvertent use of banned substances. Clinical Relevance: Educating athletes regarding the stimulant content of various dietary supplements and addressing the lack of clinical trials to support stated claims and safety appear critical.

Assessment of Critical Equipment for Preventative Maintenance of Plastic Plant

2015 ◽  
Author(s):  
Adebayo A. Aremu ◽  
Adeniyi O. Aremu ◽  
Oyetunde A. Adeaga
Keyword(s):  
Scoring System ◽  
Good Manufacturing Practice ◽  
Production Equipment ◽  
Preventative Maintenance ◽  
Industrial Plants ◽  
Maintenance Program ◽  
Manufacturing Performance ◽  
Abc Analysis ◽  
Production Facilities

With the continual demand for effective manufacturing performance, proper maintenance of production facilities and systems has become the standard of good manufacturing practice. In response, industrial plants, machines, and equipment are becoming more technically advanced, thus more complex and difficult to control and maintained. This paper is focused on a methodology for assigning relative criticality to production equipment in order to optimise a preventative maintenance program. As a case study, the authors examine equipment used in plastic production plants. Generic factors deciding the criticality were considered using a scoring system. With the use of cumulative percentage of scores, an Always Better Control (ABC) analysis was carried out and the critical equipment identified. An effective maintenance programme for the case study shows a 23%reduction of down time and also a 12.7% of equipment durability and about 96% criticality equipment factor, with optimum output. The result of this study will be significant to manufacturing company in minimizing incidences and stoppages not only on critical equipment but production facilities.

Assessment of the Status of Industrial Logistics Innovative Production Equipment and Systems in the Particular Manufacturing Company

2015 ◽  
Vol 803 ◽  
pp. 148-154
Author(s):  
Ondrej Stopka ◽  
Rudolf Kampf
Keyword(s):  
Production Equipment ◽  
Current Status ◽  
Industrial Equipment ◽  
Manufacturing Companies ◽  
Global Competitiveness ◽  
Manufacturing Company ◽  
The Status ◽  
Multi Criteria Analysis

In the first part, this paper deals with the current status of the innovative equipment and systems in the manufacturing companies and its importance within the global competitiveness. In the subsequent parts of the paper, the characteristics of particular multi-criteria analysis methods and the determination of the weightings of individual aspects (assessment criteria) that influence the situation in the developing the innovative production equipment and systems in the specific fields of industrial logistics in the particular manufacturing company when applying the selected methods of multi-criteria analysis are outlined. From the obtained outcomes, it is obvious that the assessment aspects of the manufacturing company are: (1) the grade and quality of the innovation status; (2) the business aspects and competitiveness; (3) the grade and quality of attributes of production equipment and systems and (4) the effectiveness of the logistics processes. The final part of this paper is focused on the selected manufacturing companies, dealing with the production of industrial equipment and systems, in the particular country and the application of the specific methods of the multi-criteria analysis in order to make the empirical statistics and the final complex assessment.

scholarly journals Corporate Characteristics and Adoption of Good Manufacturing Practice for Dietary Supplements in Japan

2020 ◽  
Vol 17 (13) ◽  
pp. 4748 ◽  
Author(s):  
Keigo Sato ◽  
Kota Kodama ◽  
Shintaro Sengoku
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Quality Standard ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Product Categories ◽  
Adoption And Implementation ◽  
Key Characteristics ◽  
Key Driver ◽  
A Company

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company’s adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company’s manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.

scholarly journals CLEANING VALIDATION- PREREQUISITE OF QUALITY IN DIETARY SUPPLEMENTS

2017 ◽  
Vol 44 (1) ◽  
pp. 59
Author(s):  
Davor J Koročok ◽  
Olivera Colic ◽  
Nada Tršić Milanović
Keyword(s):  
Dietary Supplements ◽  
Manufacturing Sector ◽  
Pharmaceutical Manufacturing ◽  
Final Report ◽  
Validation Process ◽  
Cleaning Validation ◽  
Manufacturing Line ◽  
Microbiological Parameters ◽  
Validation Plan ◽  
Cleaning Procedures

Manufacturers of dietary supplements meet growing regulatory demands for control of the production process, with the main goal of launching a quality based product, by which they ensure user’s protection and contentment. Demand for cleaning validation represents a multidisciplinary activity that brings together experts from around the world with a common goal: to ensure the efficacy of the cleaning operation in pharmaceutical manufacturing. Main goal of this work is to describe cleaning validation process in the manufacturing sector of liquid pharmaceutical forms- that consists of syrup and spray manufacturing. Pursuant to all guidelines of the European and National regulations, cleaning validation was initiated by designing Validation plan and Risk assessment plan for the manufacturing line of liquid pharmaceutical forms. Specified processes of cleaning were used, while specific physical, chemical and microbiological parameters were followed, and the process was complimented by a Validation protocol that documented three consecutive washing c ycles; directed at three consecutive batches of the same products on that manufacturing line for sprays. Final report of the validation process is being coordinated, followed and improved by the Quality sector. This enabled validation and efficacy of the chosen cleaning processes, but certain parameters were still being followed and analysed in order to prove conformity and/or allow changes that might arise. A goal of the pharmaceutical company to produce quality and safe products is achieved by applying principles of cleaning validation, and by using and mproving established cleaning procedures.

scholarly journals Attitude of future healthcare professionals towards food supplements

2018 ◽  
Vol 64 (1) ◽  
pp. 44-55
Author(s):  
Ewelina Wierzejska ◽  
Jana Krzysztoszek ◽  
Monika Karasiewicz
Keyword(s):  
Dietary Supplements ◽  
Ginkgo Biloba ◽  
Allium Sativum ◽  
Healthcare Professionals ◽  
Demographic Characteristics ◽  
Food Supplements ◽  
Food Supplementation ◽  
Equisetum Arvense ◽  
Good Education ◽  
The Status

Summary Introduction: The use of dietary supplements has been observed for many years. Unfortunately, the status of food supplements and main differences between these and drugs remain unknown to most consumers. Objective: The purpose of the study was to analyze the opinions of future healthcare professionals on dietary supplements, their behavior concerning food supplementation, as well as their knowledge on the safety of these products. Methods: The survey was conducted among 354 future healthcare professionals, using a questionnaire composed of 21 items exploring demographic characteristics, knowledge of supplements, reasons for the use of dietary supplement, and recall of the use. Results: All respondents knew that the purpose of using these products is supplementation. A vast majority of respondents (83.9%) thought that a diet with no supplementation is possible or probably possible. 49.4% of respondents (n=175) declared taking food supplements. The most commonly used ones (68.6%) were products recommended during illness and used to improve the condition of skin, hair, and nails. Moreover, dietary supplements mentioned by students included those containing herbal ingredients, such as: Equisetum arvense, Allium sativum, Panax ginseng, and Ginkgo biloba. Most of respondents buy dietary supplements at pharmacies (89.14%). Conclusions: Use of dietary supplements is widespread among students. Future healthcare professionals have a better knowledge on food supplementation than population of Poland in general, however, they still need good education in this matter.

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