Good Manufacturing Practice: Regulatory Requirements

Drugs ◽  
2005 ◽  
pp. 211-246
Keyword(s):  
Good Manufacturing Practice ◽  
Regulatory Requirements

Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?

2021 ◽  
Author(s):  
Johanna Rost ◽  
Steve Langhein ◽  
Detlef Bartel ◽  
Andreas Bonertz ◽  
Vera Mahler
Keyword(s):  
Cold Storage ◽  
Pharmaceutical Formulations ◽  
Storage Conditions ◽  
Good Manufacturing Practice ◽  
Type I ◽  
Regulatory Requirements ◽  
Data Loggers ◽  
Entire Duration ◽  
Refrigerated Transport ◽  
Stability Data

Abstract Background All currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The extracted proteins have different properties and their structure is differently labile to temperature variations. Despite various pharmaceutical formulations to increase product stability, with few exceptions, allergen products must be refrigerated to ensure that their quality and native protein structure do not change during storage and transport. Maintaining quality is a challenge in complex distribution chains. Methods Regulatory requirements and guidelines that apply to cold storage and transport of allergen products are summarized and the responsibilities of the stakeholders are explained. Results The storage conditions determined in stability studies correspond to the transport conditions. These stability data can also be used to assess tolerable conditions during transport. According to a good distribution practice (GDP) contracts must be concluded between the responsible pharmaceutical entrepreneur and the qualified distribution service provider that regulate storage and transport in accordance with the product requirements. Conclusion Monitoring of storage and transport conditions is achieved by transport in qualified means of transport (e.g. truck). Alternatively, qualified transport packaging with active or passive cooling (e.g. cold packs) and qualified “data loggers” that record the transport temperatures can be used. Regardless of the system used, it must be demonstrated—by validating the transport conditions, routes and packaging at different times of the year and over the entire duration of transport—that regulatory requirements are met and that the quality of the products is maintained during shipment.

scholarly journals Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction

2016 ◽  
Vol 11 (3) ◽  
pp. 307-320 ◽  
Author(s):  
Radhika Sheth-Shah ◽  
Amanda J Vernon ◽  
Shankar Seetharaman ◽  
Michael H Neale ◽  
Julie T Daniels
Keyword(s):  
Epithelial Cell ◽  
Surface Reconstruction ◽  
Ocular Surface ◽  
Good Manufacturing Practice ◽  
Regulatory Requirements ◽  
Ocular Surface Reconstruction

scholarly journals Regulatory Comparative Quality Systems of India and USA and its Significance in Pharmaceutical Industry Facilities

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 2457-2462
Author(s):  
Prabhakar V S ◽  
Beula Evangeline C ◽  
Aravindhanathan V ◽  
Sruthi N ◽  
Gowthamarajan K
Keyword(s):  
United States ◽  
Pharmaceutical Industry ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
Primary Objective ◽  
Regulatory Requirements ◽  
Quality Management Systems ◽  
Pharmaceutical Manufacturers ◽  
Speed Up

The intentions of the current study are to compare the regulatory requirements of USFDA and CDSCO-Schedule M in GMP with significance to the pharmaceutical industry to speed up the criteria for enforcement to facilitate the regulatory approval of specified pharmaceutical products in the United States and India. The literature search is done using different resources, such as regulatory authority websites, pharmaceutical review articles, journals and public domains. To discuss the numerous dilemmas, root causes and challenges confront by pharmaceutical companies and to suggest remedial and pro-active measures to GMP issues and all pharmaceutical manufacturers are required to develop and enforce effective quality control systems in order to ensure quality. Whereas the regulated markets like the United States have well-established guidance compared to emerging markets like India on good manufacturing practice compliance, to assess the effectiveness of this quality management systems, inspections are carried out on manufacturing units. The primary objective of the analysis is to differentiate between the type of application or license that causes the inspection and the outcome of the inspection and to also provide enough details identified by the authority during the evaluation.

scholarly journals COMPARISON OF REQUIREMENTS OF ANNEX 1 TO THE RULES OF GOOD MANUFACTURING PRACTICE OF THE EURASIAN ECONOMIC UNION AND REQUIREMENTS OF THE DRAFT ANNEX 1 GMP PIC/S

2020 ◽  
Vol 2 (2) ◽  
pp. 8-19
Author(s):  
Anna V. Basevich ◽  
Irina E. Kaukhova ◽  
Artemy A. Kodash ◽  
Tatyana A. Bitkina ◽  
Elena M. Smirnova ◽  
...  
Keyword(s):  
International Organizations ◽  
Action Plan ◽  
Good Manufacturing Practice ◽  
Organizational Level ◽  
Pharmaceutical Companies ◽  
Current Version ◽  
Regulatory Requirements ◽  
Eurasian Economic Union ◽  
Organizational Work ◽  
Economic Union

This article provides an overview on draft GMP EC Annex 1 revision progress and, as a consequence, the GMP PIC/S. The role and position of Russia in the pharmaceutical market, its inclusion in international organizations involved in the regulation of the production and circulation of drugs has been indicated. The interconnection between economic integration processes, changes in international regulatory requirements and national legislation has been demonstrated. The article shows how changes in the laws governing the pharmaceutical industry entail changes in the organization of manufacturing or in the approach to the manufacturing process at the organizational level and/or lead to material expenses to eliminate incompliance. Keeping track of possible future changes in legislation allows to pre-build a plan for eliminating incompliance. When analyzing the changes in the Draft Appendix 1 regarding the current version of Appendix 1, it has been revealed that the documents have significant differences. To eliminate significant incompliances with a number of paragraphs of the draft Appendix 1, it is necessary to make changes not only in the operating procedures, but also in the planning solutions of production sites. Based on the results of the work carried out, it has been established that the introduction of the draft Annex 1 GMP PIC/S and its implementation in the GMP EAEU requirements will lead to incompliance at existing pharmaceutical enterprises, the elimination of which requires a lot of organizational work. Significant changes at the existing enterprise are required in accordance with 14 points of the draft. This article presents clauses 5.9, clause 5.21, clause 8.7, clause 8.16, clause 8.29, clause 9.17, clause 9.33 - this is due to that most of these requirements are absent in the current valid requirements of GMP EAEU and Russian GMP rules. The comparison made is an occasion for pharmaceutical companies to conduct internal audits for compliance with the requirements of the draft GMP PIC/S Annex 1 in order to preventively identify incompliances and develop an action plan to address them.

scholarly journals Overview on Regulatory Requirements for Medical Devices in Srilanka - National Medicines Regulatory Authority/NMRA

2021 ◽  
pp. 567-576
Author(s):  
Vishakharaju Motupalli ◽  
Subhash Chandra Bose ◽  
M. P. Venkatesh ◽  
Varsha Tiwari ◽  
Gembali Ramya
Keyword(s):  
Medical Devices ◽  
Regulatory Authority ◽  
Product Information ◽  
Evaluation Process ◽  
Good Manufacturing Practice ◽  
Regulatory Requirements ◽  
Extra Copy ◽  
Reception Point ◽  
One Year ◽  
Monitoring Treatment

In the health-care industry, medical devices are becoming increasingly significant. One of the most challenging aspects of developing and manufacturing medical devices is keeping up with regulatory regulations and incorporating them into the process Registration, licensing, manufacture, importation, and all other elements of medical devices shall be regulated and controlled by the National Medicines Regulatory Authority in accordance with the National Medicines Policy. In this article we discuss about regulatory overview and registration of medical devices in Sri Lanka. A “medical device,” as defined by the Act, is any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, that is used in or on humans for the purposes of:  Diagnosis, prevention, monitoring, treatment, or alleviation of disease; Anatomy or physiological process investigation, replacement, or alteration, Conception control. Any change in product information should be reported to the NMRA as soon as possible during the evaluation process and after product registration, especially if it involves rejection/withdrawal, additional data on product quality, effectiveness, or safety, or the manufacturers' current Good Manufacturing Practice (cGMP) compliance. The sample license will be produced in three copies, each of which will be valid for one year from the date of issue, and will be available for pick-up at the reception point. (An extra copy of the dossier will be included).

The Confusion of Design and Facilities in Good Manufacturing Practice Requirements among Industries in Malaysia

2016 ◽  
Vol 1 (3) ◽  
Author(s):  
Mohd Bakri Jali ◽  
Maaruf Abdul Ghani ◽  
Norazmir Md Nor
Keyword(s):  
Food Safety ◽  
Food Production ◽  
Publishing House ◽  
Good Manufacturing Practice ◽  
Food Hygiene ◽  
Regulatory Requirements ◽  
Food Industries ◽  
Manufacturing Operations ◽  
International Publishing ◽  
Qualitative Technique

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and Good Manufacturing Practice (GMP) to successfully market their products as safe and high quality products. GMP is a component of the food safety system to ensure the control of public hygiene and environmental conditions of the food production process. This study aims to investigate the confusion over design and facilities elements among food industries through qualitative technique. Design and facilities elements lay a firm foundation for GMP to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines. © 2016. The Authors. Published for AMER ABRA by e-International Publishing House, Ltd., UK. Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians) and cE-Bs (Centre for Environment-Behaviour Studies, Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia.Keywords: food safety; food hygiene; GMP; HACCP

scholarly journals The Confusion of Design and Facilities in Good Manufacturing Practice Requirements among Industries in Malaysia

2016 ◽  
Vol 1 (3) ◽  
pp. 156
Author(s):  
Mohd Bakri Jali ◽  
Maaruf Abdul Ghani ◽  
Norazmir Md Nor
Keyword(s):  
Food Safety ◽  
Publishing House ◽  
Good Manufacturing Practice ◽  
Food Hygiene ◽  
Regulatory Requirements ◽  
Food Industries ◽  
Manufacturing Operations ◽  
International Publishing ◽  
Qualitative Technique ◽  
Open Access Article

Food manufacturing operations need to fulfil regulatory requirements related to hygiene and Good Manufacturing Practice (GMP) to successfully market their products as safe and high quality products. GMP is a component of the food safety system to ensure the control of public hygiene and environmental conditions of the food production process. This study aims to investigate the confusion over design and facilities elements among food industries through qualitative technique. Design and facilities elements lay a firm foundation for GMP to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines. © 2016. The Authors. Published for AMER ABRA by e-International Publishing House, Ltd., UK. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).Peer–review under responsibility of AMER (Association of Malaysian Environment-Behaviour Researchers), ABRA (Association of Behavioural Researchers on Asians) and cE-Bs (Centre for Environment-Behaviour Studies), Faculty of Architecture, Planning & Surveying, Universiti Teknologi MARA, Malaysia.Keywords: food safety; food hygiene; GMP; HACCP

Letter to the Editor: The Continuing Challenge of Evaluating RSD Impairment and Disability

1998 ◽  
Vol 3 (5) ◽  
pp. 8-10
Author(s):  
Robert L. Knobler ◽  
Charles N. Brooks ◽  
Leon H. Ensalada ◽  
James B. Talmage ◽  
Christopher R. Brigham
Keyword(s):  
Disability Evaluation ◽  
Body Part ◽  
Loss Of Function ◽  
Regulatory Requirements ◽  
Major Cardiac Event ◽  
Clinical Scenarios ◽  
Impairment Score ◽  
Occupational Activities ◽  
The Difference

Abstract The author of the two-part article about evaluating reflex sympathetic dystrophy (RSD) responds to criticisms that a percentage impairment score may not adequately reflect the disability of an individual with RSD. The author highlights the importance of recognizing the difference between impairment and disability in the AMA Guides to the Evaluation of Permanent Impairment (AMA Guides): impairment is the loss, loss of use, or derangement of any body part, system, or function; disability is a decrease in or the loss or absence of the capacity to meet personal, social, or occupational demands or to meet statutory or regulatory requirements because of an impairment. The disparity between impairment and disability can be encountered in diverse clinical scenarios. For example, a person's ability to resume occupational activities following a major cardiac event depends on medical, social, and psychological factors, but nonmedical factors appear to present the greatest impediment and many persons do not resume work despite significant improvements in functional capacity. A key requirement according to the AMA Guides is objective documentation, and the author agrees that when physicians consider the disability evaluation of people, more issues than those relating to the percentage loss of function should be considered. More study of the relationships among impairment, disability, and quality of life in patients with RSD are required.

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