Pharmaceutical process validation: An overview

2003 ◽  
Vol 217 (2) ◽  
pp. 141-151 ◽  
Author(s):  
H Aleem ◽  
Y Zhao ◽  
S Lord ◽  
T McCarthy ◽  
P Sharratt
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Pharmaceutical Industry ◽  
Special Reference ◽  
Product Quality ◽  
Regulatory Requirement ◽  
Process Validation ◽  
Critical Elements ◽  
The Us

Drugs are critical elements in health care. They must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used. In the pharmaceutical industry, process validation performs this task, ensuring that the process does what it purports to do. It is also a regulatory requirement. This paper presents an introduction and general overview of this process, with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).

scholarly journals Process validation: An essential process in pharmaceutical industry

2015 ◽  
Vol 1 (4) ◽  
pp. 179
Author(s):  
Brahmaiah Bonthagarala ◽  
Sandhya Ch. ◽  
Pusuluri Dharani Lakshmi Sai ◽  
Konkipudi Venkata Sivaiah
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Pharmaceutical Industry ◽  
Manufacturing Process ◽  
Iso 9000 ◽  
Pharmaceutical Manufacturing ◽  
Process Validation ◽  
The Us ◽  
Tablet Manufacturing

The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA).Quality is always an imperative prerequisite when we consider any product. Therefore, drugs must be manufactured to the highest quality levels. End-product testing by itself does not guarantee the quality of the product. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.

A REVIEW ON PHARMACEUTICAL VALIDATION AND ITS IMPORTANCE AND IMPUTATION

2021 ◽  
Vol 12 (10) ◽  
pp. 23-26
Author(s):  
M Mohankumar ◽  
G Sivakamasundari
Keyword(s):  
Quality Assurance ◽  
Creative Process ◽  
Process Validation ◽  
The Us ◽  
Measurement Control ◽  
Quantitative Validation ◽  
Measurement Validation ◽  
Quality Of Products ◽  
Pharmaceutical Production

Validation is a notable step in fulfilling and keep the character of the last decision. In the event that every progress of the creative process is recognized, we can guarantee that the end result will be of the best quality. Validation is specialized for planning and rehearsing a closely planned step with documents. Verification and quality assurance are inseparable, which guarantees careful quality of products. The process validation underscores the components of the measurement scheme and adheres to the measurement control during commercialization and realizes that it is nothing more than a continuous program and adjust the measurement validation exercises with the item life cycle. The motivation behind this survey is to introduce a presentation and general disclosure on quantitative validation of pharmaceutical production with a unique note to the requirements specified by the US Food and Drug Administration (FDA).

scholarly journals THE ACTUALIZATION OF THE INCREASED COMPETITIVENESS OF OIL PRODUCTS RUB HERBACEOUS TRADITIONALLY THROUGH BRANDING AND CERTIFICATION OF PRODUCT QUALITY ASSURANCE UMK RAMBAL DELI IN KECAMATAN GALANG

2019 ◽  
Vol 3 (1) ◽  
pp. 33
Author(s):  
Roza Thohiri ◽  
Andri Zainal ◽  
Pasca Dwi Putra ◽  
Joko Suharianto
Keyword(s):  
Quality Assurance ◽  
Product Quality ◽  
Product Innovation ◽  
Explicit Knowledge ◽  
The Body ◽  
Oil Products ◽  
Pocket Book ◽  
Quality Of Products ◽  
The City

The activities of the CPM with the title of “the Actualization of the Improvement of the Competitiveness of the Product Oil Scrub Traditional Herbs Through Branding and Certification Guarantee the Quality of Products UMK Rambal Deli in District Girders” this is focused on penuntasan 3 (three) problems specific be problem specific namely (1) Absence of the actualization of the knowledge explicit (explicit knowledge) in the product oil rub the traditional herbs that is produced; (2) product competitiveness the relative weakness with the management of production, marketing and finance is still traditional and; (3) the Body efforts yet there the body order official and permit the efforts which have not yet registered. Partners involved in the activities of the CPM this is the UMK Rambal Deli led by Mr. Agus Hidayat. UMK is located in the Street Sergeant M. Arifin gg. Muslim Lk. II wards Girders of the City, Subdistrict Girders, Regency of Deli Serdang. As an alternative solution for the settlement of the problem referred to consists of: (1) documentation of the profile and the formula of the products in print and electronic; (2) modernization and amplification of diffuse marketing: finishing and marketing system, and; (3) the assitance management certificate stand SME and business licenses. The activities of the CPM this will produce some external of them: The Proceedings, the Application of ABOUT and Product Innovation, draft pocket book, assitance management certificate stand order and clearance order.Keywords: SME, Certificate of Incorporation, Business license, Packaging.

scholarly journals Quality assurance of health management information system in Kayunga district, Uganda

2018 ◽  
Vol 6 (2) ◽  
Author(s):  
Harriet R. Kagoya ◽  
Dan Kibuule
Keyword(s):  
Health Care ◽  
Information System ◽  
Quality Assurance ◽  
Management Information System ◽  
Health Management ◽  
Care Delivery ◽  
Public Health Care ◽  
Health Management Information System ◽  
Management Information

Background: An efficient health management information system (HMIS) improves health care delivery and outcomes. However, in most rural settings in Uganda, paper-based HMIS are widely used to monitor public health care services. Moreover, there are limited capabilities and capacity for quality HMIS in remote settings such as Kayunga district.Objectives: The quality assurance practices of HMIS in health centres (HCs) in Kayunga district were evaluated.Method: A cross-sectional descriptive study design was used to assess the quality of HMIS at 21 HCs in Kayunga district. Data were collected through in-depth interviews of HMIS focal persons as well as document analysis of HMIS records and guidelines between 15 June 2010 and 15 July 2010. The main outcomes were quality assurance practices, the HMIS programmatic challenges and opportunities. The practice of HMIS was assessed against a scale for good quality assurance practices. Qualitative data were coded and thematically analysed, whereas quantitative data were analysed by descriptive statistics using SPSS v22 software.Results: All the 21 HCs had manual paper-based HMIS. Less than 25% of HCs practised quality assurance measures during collection, compilation, analysis and dissemination of HMIS data. More than 50% of HCs were not practising any type of quality assurance during analysis and dissemination of data. The main challenges of the HMIS were the laborious and tedious manual system, the difficulty to archive and retrieve records, insufficient HMIS forms and difficulty in delivering hard copies of reports to relevant stakeholders influenced quality of data. Human resource challenges included understaffing where 43% of participating HCs did not have a designated HMIS staff.Conclusion: The HMIS quality assurance practices in Kayunga were suboptimal. Training and support supervision of HMIS focal persons is required to strengthen quality assurance of HMIS. Implementation of electronic HMIS dashboards with data quality checks should be integrated alongside the manual system.

Supporting older military veterans in the rural US

2018 ◽  
Vol 19 (4) ◽  
pp. 286-297
Author(s):  
Bret Hicken ◽  
Kimber Parry
Keyword(s):  
Health Care ◽  
Rural Areas ◽  
Access To Health Care ◽  
Veterans Health ◽  
Health Administration ◽  
Care Needs ◽  
Content Type ◽  
Access To Health ◽  
The Us

Purpose The purpose of this paper is to provide an overview of rural older veterans in the US and discuss how the US Department of Veterans Affairs (VA) is increasing access to health care for older veterans in rural areas. Design/methodology/approach This is a descriptive paper summarizing population and program data about rural veterans. Findings VA provides a variety of health care services and benefits for older veterans to support health, independence, and quality of life. With the creation of the Veterans Health Administration Office of Rural Health (ORH) in 2006, the needs of rural veterans, who are on average older than urban veterans, are receiving greater attention and support. ORH and VA have implemented several programs to specifically improve access to health care for rural veterans and to improve quality of care for older veterans in rural areas. Originality/value This paper is one of the first to describe how VA is addressing the health care needs of older, rural veterans.

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