scholarly journals Extemporaneous Compounding: Cautions, Controversies and Convenience

2019 ◽  
Vol 9 (1) ◽  
pp. 252-264 ◽  
Author(s):  
AK Mohiuddin*
Keyword(s):  
Quality Control ◽  
Clinical Performance ◽  
Release Kinetics ◽  
Continuous Process ◽  
Pharmacy Practice ◽  
Good Manufacturing Practice ◽  
Patient Needs ◽  
Additional Risk ◽  
Approved Drugs ◽  
Extemporaneous Preparation

Pharmacists are only knowledgeable and skilled healthcare professionals dedicated to compounding and preparing medications to meet the unique needs of patients. The safe and effective extemporaneous compounding of prescription products for patients require in special care is fundamental to the pharmacy profession. But there are much to do for secundum artem. It is not at all economical for a pharmaceutical company to marketize a product in 10 different probable doses or in 5 different dosage forms to meet the needs of the entire range of individuals receiving therapy. Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances. Purpose of The Study: The article aims to physico-chemical and economic considerations before compounding; factors and quality control issues; compounding support, training, chemical supplies, types of compounding (specially in hospital and ambulatory care compounding). It should aid to practice the extemporaneous preparation of basic and advanced formulations including pharmacopoeial and non-pharmacopoeial formulations encountered in pharmacy practice, together with requisite documentation, labeling, packaging and counseling requirements. Along with this, they have to study the analysis of formulations and their components and relate these to the clinical performance of medicines. This will help them to investigate, evaluate and report the physical characteristics of formulations including release kinetics and relate these to quality control and preformulation requirements; relate the application of quality control, quality assurance and the principles of good manufacturing practice to regulation of medicine production in home and abroad. Outline: Background; Introduction; Compounding Factors; Types of Compounding; Identifying Errors and Cause

scholarly journals Extemporaneous Compounding: Selective Pharmacists with Separate Skill

2019 ◽  
Vol 10 (4) ◽  
pp. 3
Author(s):  
AK Mohiuddin
Keyword(s):  
Microbial Contamination ◽  
Continuous Process ◽  
State Agencies ◽  
Patient Needs ◽  
Additional Risk ◽  
Article Type ◽  
Suitable Treatment ◽  
Approved Drugs ◽  
Fda Approved Drugs ◽  
Compounded Drug

Extemporaneous compounding takes place in community and hospital pharmacies. There are usually specialist compounding pharmacies in major towns and cities, but any pharmacy may undertake compounding as long as they have appropriate facilities according to state-based legislation (e.g. allocated clean bench, specific compounding equipment). Although development is a continuous process, companies are customizing features to meet the majority of patient needs, but the very nature of the process cannot meet all patient needs. The risk-benefit ratio of using traditionally compounded medicines is favorable for patients who require specialized medications that are not commercially available, as they would otherwise not have access to suitable treatment. However, if an FDA-approved drug is commercially available, the use of an unapproved compounded drug confers additional risk with no commensurate benefit. Published reports of independent testing by the FDA, state agencies, and others consistently show that compounded drugs fail to meet specifications at a considerably higher rate than FDA-approved drugs. Compounded sterile preparations pose the additional risk of microbial contamination to patients. In the last 11 years, three separate meningitis outbreaks have been traced to purportedly ‘sterile’ steroid injections contaminated with fungus or bacteria, which were made by compounding pharmacies. The 2012 outbreak has resulted in intense scrutiny of pharmacy compounding practices and increased recognition of the need to ensure that compounding is limited to appropriate circumstances.   Article Type: Review

scholarly journals Comparing the Performance of Several Multivariate Control Charts Based on Residual of Multioutput Least Square SVR (MLS-SVR) Model in Monitoring Water Production Process

2021 ◽  
Vol 2123 (1) ◽  
pp. 012018
Author(s):  
M Ahsan ◽  
T R Aulia
Keyword(s):  
Water Quality ◽  
Quality Control ◽  
Control Charts ◽  
Continuous Process ◽  
Quality Characteristics ◽  
Least Square ◽  
Support Vector ◽  
Water Quality Control ◽  
Multivariate Control Charts ◽  
Multivariate Control

Abstract Water that is used as the basic human need, requires a processing process to get it. Water quality control in Tirtanadi Water Treatment Plant is still univariate, while theoretically the quality characteristics of water quality are correlated and there is also an autocorrelation due to the continuous process. In this study, quality control is performed on three main variables of water quality characteristics, namely acidity (pH), chlorine residual (ppm), and turbidity (NTU) using several multivariate control charts based on Multioutput Least Square Support Vector Regression (MLS-SVR) residuals. MLS-SVR modelling is used to overcome and get rid of autocorrelation. The input results of the MLS-SVR model are specified from the significant lag of the Partial Autocorrelation Function (PACF), which in this study, is the first lag. The results of the MLS-SVR input model and the optimal combination of hyper-parameters produce residual values that have no autocorrelation anymore. The residuals are used to develop the Hotelling’s T 2, Multivariate Exponentially Weighted Moving Average (MEWMA), and Multivariate Cumulative Sum (MCUSUM) control charts. In phase I, we found that the processes are statically controlled. Meanwhile, in phase II, the monitoring results show that there are several out-of-control observations.

scholarly journals PERENCANAAN PERBAIKAN MUTU PRODUK DENGAN METODE KAIZEN PADA PERUSAHAAN

2017 ◽  
Author(s):  
Abdurrozzaq Hasibuan
Keyword(s):  
Quality Control ◽  
Data Processing ◽  
Animal Feed ◽  
Raw Materials ◽  
Continuous Process ◽  
Ash Content ◽  
Water Levels ◽  
Output Stage ◽  
Control Limits

Kaizen is a Japanese concept that means improvement continuous process to constantly improve the quality and productivity output. Stage of the data processing is done in this study using seven quality control tools (seven tools). From the results of the data processing is done by using the seven tools of quality control so visible damage that occurs feed the ash High temperatures, low water levels and the color is not uniform feed. Histogram and Pareto diagram showing the greatest amount of damage to small, the color is not uniform feed as many as 6800 Kg (41.34%), high ash content as much as 5050 Kg (30.70%) and low water levels as much as 4600 Kg (27.96%).Based on a causal diagram can be seen several causes defects in animal feed products C-281 human factors, among others, due to lack of skill or abilities of the workers themselves, less rigorous labor in performing measurements so the size does not match the required specifications. And factors that usually raw materials can cause defects in animal feed products C-281 is due to the quality of the raw materials are not in accordance with the standards set by the previous company. From the calculation of the map control is obtained that no data which are beyond the control chart or no data outside the control limits.

Better get moving on laboratory quality assurance

2019 ◽  
Vol 32 (1) ◽  
pp. 84-86
Author(s):  
Sidra Asad Ali ◽  
Muhammad Shariq Shaikh
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Clinical Laboratory ◽  
Improve Patient Safety ◽  
Continuous Process ◽  
Control Measures ◽  
Test Results ◽  
Quality Control Program ◽  
Content Type ◽  
Quality Control Process

Purpose With recent advances in laboratory hematology automation, emphasis is now on quality assurance processes as they are indispensable for generating reliable and accurate test results. It is therefore imperative to acquire efficient measures for recognizing laboratory malfunctions and errors to improve patient safety. The paper aims to discuss these issues. Design/methodology/approach Moving algorithm is a quality control process that monitors analyzer performance from historical records through a continuous process, which does not require additional expenditure, and can serve as an additional support to the laboratory quality control program. Findings The authors describe an important quality assurance tool, which can be easily applied in any laboratory setting, especially in cost-constrained areas where running commercial controls throughout every shift may not be a feasible option. Originality/value The authors focus on clinical laboratory quality control measures for providing reliable test results. The moving average appears to be a reasonable and applicable choice for vigilantly monitoring each result.

scholarly journals Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards

2021 ◽  
Vol 24 (2) ◽  
pp. 59-67
Author(s):  
Ji-Eun Han ◽  
Minjung Park ◽  
Tteul-E-Bom An ◽  
Jong-Hyun Park ◽  
Danny Oh ◽  
...  
Keyword(s):  
Quality Control ◽  
Comparative Study ◽  
Good Manufacturing Practice

Some Remarks on the Design of Three-Class Sampling Plans

1998 ◽  
Vol 61 (6) ◽  
pp. 757-761 ◽  
Author(s):  
S. DAHMS ◽  
G. HILDEBRANDT
Keyword(s):  
Maximum Level ◽  
Good Manufacturing Practice ◽  
Sampling Plan ◽  
Single Sample ◽  
Contamination Level ◽  
Sampling Plans ◽  
Additional Risk ◽  
Bacterial Counts ◽  
Sample Result ◽  
The Relationship

Among the variety of sampling plans for the evaluation of bacterial counts the attributive three-class sampling plan has widely gained acceptance because of its simple application and its robust functionality. However, the performance characteristics of three-class sampling plans depend on lot heterogeneity and the distance between the microbiological limits m and M, which are the maximum level of target organisms under conditions of good manufacturing practice (GMP) and the level of target organisms that is considered as unacceptable or defective. The probability of lot rejection due to a single sample result above M increases with increasing lot heterogeneity and/or with decreasing distance between these limits. Especially for investigations on nonpathogenic microorganisms it is questionable whether a lot still meeting GMP conditions should be rejected solely because a single sample result lies above M. Taking the often used three-class sampling plan (n = 5; cm = 2, cM = 0) as an example, it is demonstrated how insight into the relationship between sample variability and an appropriate distance between m and M can be gained. These calculations are based on the assumptions that logarithmically transformed bacterial counts follow a normal distribution and that an indifference lot with a contamination level at m is to be evaluated. For this kind of lot the probability of acceptance or rejection is equally 0.5 according to the two-class sampling plan. Introducing a limit for the additional risk of rejection of an indifference lot with acceptable heterogeneity when the three-class sampling plan is applied, a criterion for choosing the distance between m and M is developed.

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