scholarly journals Practical guidelines for the characterization and quality control of pure drug nanoparticles and nano-cocrystals in the pharmaceutical industry

2018 ◽  
Vol 131 ◽  
pp. 101-115 ◽  
Author(s):  
Leena Peltonen
Keyword(s):  
Quality Control ◽  
Pharmaceutical Industry ◽  
Drug Nanoparticles ◽  
Practical Guidelines ◽  
Pure Drug

SU-FF-I-79: Development of The Practical Guidelines of PET-CT Quality Control

2009 ◽  
Vol 36 (6Part4) ◽  
pp. 2452-2452 ◽  
Author(s):  
K Kwang ◽  
B Lee ◽  
J Choe
Keyword(s):  
Quality Control ◽  
Pet Ct ◽  
Practical Guidelines

scholarly journals Metrological Regulations for Quality Control Equipment Calibration in Pharmaceutical Industry

2015 ◽  
Vol 132 ◽  
pp. 811-815 ◽  
Author(s):  
F. Losada-Urzáiz ◽  
C. González-Gaya ◽  
M.Á. Sebastián-Pérez
Keyword(s):  
Quality Control ◽  
Pharmaceutical Industry ◽  
Control Equipment

scholarly journals Pharmaceutical Industry in Uganda: A Review of the Common GMP Non-conformances during Regulatory Inspections

2021 ◽  
Author(s):  
Nasser Lubowa ◽  
Zita Ekeocha ◽  
Stephen Robert Byrn ◽  
Kari L Clase
Keyword(s):  
Quality Control ◽  
Pharmaceutical Industry ◽  
Large Scale ◽  
Production Capacity ◽  
Parameter Analysis ◽  
Small Scale ◽  
Middle Income ◽  
Substandard Medicines ◽  
The Status ◽  
Pharmaceutical Industries

The prevalence of substandard medicines in Africa is high but not well documented. Low and Middle-Income Countries (LMICs) are likely to face considerable challenges with substandard medications. Africa faces inadequate drug regulatory practices, and in general, compliance with Good Manufacturing Practices (GMP) in most of the pharmaceutical industries is lacking. The majority of pharmaceutical manufacturers in developing countries are often overwhelmed by the GMP requirements and therefore are unable to operate in line with internationally acceptable standards. Non-conformances observed during regulatory inspections provide the status of the compliance to GMP requirements. The study aimed to identify the GMP non-conformances during regulatory inspections and gaps in the production of pharmaceuticals locally manufactured in Uganda by review of the available 50 GMP reports of 21 local pharmaceutical companies in Uganda from 2016. The binary logistic generalized estimating equations (GEE) model was applied to estimate the association between odds of a company failing to comply with the GMP requirements and non-conformances under each GMP inspection parameter. Analysis using dummy estimation to linear regression included determination of the relationship that existed between the selected variables (GMP inspection parameters) and the production capacity of the local pharmaceutical industry. Oral liquids, external liquid preparations, powders, creams, and ointments were the main categories of products manufactured locally. The results indicated that 86% of the non-conformances were major, 11% were minor, and 3% critical. The majority of the non-conformances were related to production (30.1%), documentation (24.5%), and quality control (17.6%). Regression results indicated that for every non-conformance under premises, equipment, and utilities, there was a 7-fold likelihood of the manufacturer failing to comply with the GMP standards (aOR=6.81, P=0.001). The results showed that major non-conformances were significantly higher in industries of small scale (B=6.77, P=0.02) and medium scale (B=8.40, P=0.04), as compared to those of large scale. This study highlights the failures in quality assurance systems and stagnated GMP improvements in these industries that need to be addressed by the manufacturers with support from the regulator. The addition of risk assessment to critical production and quality control operations and establishment of appropriate corrective and preventive actions as part of quality management systems are required to ensure that quality pharmaceuticals are manufactured locally.

scholarly journals Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry

2014 ◽  
Vol 50 (1) ◽  
pp. 213-223 ◽  
Author(s):  
Tahisa Marcela Pedroso ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Quality Control ◽  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Pharmaceutical Industry ◽  
High Performance ◽  
Fractional Factorial ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Cefazolin Sodium ◽  
Liquid Chromatography Method

A reversed-phase high performance liquid chromatography method was validated for the determination of cefazolin sodium in lyophilized powder for solution for injection to be applied for quality control in pharmaceutical industry. The liquid chromatography method was conducted on a Zorbax Eclipse Plus C18 column (250 x 4.6 mm, 5 μm), maintained at room temperature. The mobile phase consisted of purified water: acetonitrile (60: 40 v/v), adjusted to pH 8 with triethylamine. The flow rate was of 0.5 mL min-1 and effluents were monitored at 270 nm. The retention time for cefazolin sodium was 3.6 min. The method proved to be linear (r2=0.9999) over the concentration range of 30-80 µg mL-1. The selectivity of the method was proven through degradation studies. The method demonstrated satisfactory results for precision, accuracy, limits of detection and quantitation. The robustness of this method was evaluated using the Plackett–Burman fractional factorial experimental design with a matrix of 15 experiments and the statistical treatment proposed by Youden and Steiner. Finally, the proposed method could be also an advantageous option for the analysis of cefazolin sodium, contributing to improve the quality control and to assure the therapeutic efficacy.

The Political Economy of Controlling Transnationals: The Pharmaceutical Industry in Sri Lanka, 1972–1976

1978 ◽  
Vol 8 (2) ◽  
pp. 299-328 ◽  
Author(s):  
Sanjaya Lall ◽  
Senaka Bibile
Keyword(s):  
Drug Delivery ◽  
Developing Countries ◽  
Quality Control ◽  
Sri Lanka ◽  
Pharmaceutical Industry ◽  
Medical Profession ◽  
Political Leadership ◽  
The Political ◽  
Great Care ◽  
Set Up

This paper describes the experience of Sri Lanka in reforming the structure of production, importation, and distribution of pharmaceuticals in the period 1972–1976. It highlights the actions and reactions of transnational pharmaceutical corporations to these reforms, and traces the achievements and problems of the State Pharmaceuticals Corporation which was set up to implement the reforms. The roles of political leadership in regulating the power of drug transnationals, and of the medical profession in resisting reform, seem to be of crucial significance. Developing countries wishing to lower the present high cost of drug delivery must proceed with great care and immense caution, since complex problems of quality control, bioequivalence, medical acceptance, and consumer reeducation are involved.

Sign in / Sign up

Export Citation Format

Share Document