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.

Determination of Residues of Acetaminophen, Caffeine, and Drotaverine Hydrochloride on Swabs Collected from Pharmaceutical Manufacturing Equipment Using HPLC in Support of Cleaning Validation

2014 ◽  
Vol 97 (5) ◽  
pp. 1439-1445 ◽  
Author(s):  
Mohamed E M Hassouna ◽  
Yousry M Issa ◽  
Ashraf G Zayed
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Equipment ◽  
Cleaning Validation ◽  
Accuracy And Precision ◽  
Drotaverine Hydrochloride ◽  
Time Required ◽  
Isocratic Mode

Abstract An HPLC method was developed for the simultaneous determination of residues of acetaminophen (paracetamol, PA), caffeine (CA), and drotaverine HCl (DH) on swabs collected from pharmaceutical manufacturing equipment surfaces. The challenge in cleaning validation is to develop analytical methods that are sensitive enough to detect traces of the active compounds remaining on the surface of pharmaceutical manufacturing equipment after cleaning. Chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using the mobile phase 0.02 M tetrabutylammonium bisulfate–methanol (100 + 45, v/v) at 50°C with UV detection at 210 nm. The method was tested for specificity, linearity, LOD, LOQ, accuracy, and precision for determination of traces of the above-mentioned drugs. The time required for a single analysis was 12 min. The response was linear in the ranges of 6.900–52.100, 1.040–7.800, and 0.694–5.210 μg/mL for PA, CA, and DH, respectively.

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.

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