— good manufacturing practices for pharmaceutical products

... NAM TRƯỜNG ĐẠI HỌC NGÂN HÀNG TP.HCM - - ĐỀ TÀI: HỆ THỐNG THỰC HÀNH SẢN XUẤT TỐT GOOD MANUFACTURING PRACTICES – GMP Giảng viên hướng dẫn : Ths Lâm Hoàng Phương Lớp : D01 Nhóm thực : Nguyễn ... Năm 2017 Giới thiệu GMP 1.1 Khái niệm GMP Trang “Hệ thống thực hành sản xuất tốt – GMP (Good Manufacturing Practices) hệ thống đảm bảo chất lượng, vệ sinh, an toàn áp dụng sở sản xuất, chế biến ... yêu cầu GMP Trong nông nghiệp GAP ? ?Good Agriculture Practice” – Thực hành nông nghiệp tốt Trong công nghiệp làm tiêu chuẩn GHP ? ?Good Hygien Practice” GPP ? ?Good Pharmacy Practice” – Thực hành

Ngày tải lên: 13/04/2017, 21:27

... guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms In: WHO Expert Committee on Specifications for Pharmaceutical ... Health Canada, 2004 WHO good manufacturing practices for sterile pharmaceutical products In: WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-fourth report Geneva, World ... Health Organization WHO Technical Report Series, No 957, 2010 Annex WHO good manufacturing practices for pharmaceutical products containing hazardous substances Introduction General Glossary Risk

Ngày tải lên: 03/12/2017, 23:59

... Guideline for Pharmaceutical Products 2013(Final Draft 7.2) MiVPA20 Minor change of the manufacturing process for non-sterile product C The same currently approved manufacturing site The overall manufacturing ... ASEAN Variation Guideline for Pharmaceutical Products 2013(Final Draft 7.2) ASEAN VARIATION GUIDELINE FOR PHARMACEUTICAL PRODUCTS INTRODUCTION Throughout the life of a pharmaceutical product, the ... site is appropriately authorized for the pharmaceutical form concerned such as a valid Good Manufacturing Practice (GMP) certificate and/or a Certificate of Pharmaceutical Product (CPP) which

Ngày tải lên: 04/12/2017, 02:39

... Comparative tabulated format change of the in-process controls 27 ASEAN Variation Guideline for Pharmaceutical Products, 2012 7.2 draft MiVPA20 Minor change of the manufacturing process for non-sterile ... product For major change in the manufacturing process for drug product, please refer to MaV-9 D Description of the new manufacturing process and technical justification for the change For semi ... marketing authorization holder for pharmaceutical products for human use only and not including biologics DEFINITION 3.1 Major variation (MaV) Variation to a registered pharmaceutical finished product

Ngày tải lên: 04/12/2017, 03:58

... (LE DESS CAAE "MANAGER") Report Presented by Mau Chien DANG FEASffiILITY STUDY FOR A MANuFACTURING SITE FOR ABRASIVE PRODUCTS IN VIETNAM September 1995 - , I •• ' oJ U/r '1' l, V Y Under Direction ... This letter serves as confinnntion that your project to conduct a feasibility study of starting a manufacturing f:.lcility in Vidnam has been satisfactorily completed In addition, I would like to

Ngày tải lên: 09/02/2021, 08:10

... storage Good practice - a practice or set of practices designed to ensure that food products, services, etc., are executed according to prescribed food safety standards Examples of ? ?good practices? ?? ... prescribed food safety standards Examples of ? ?good practices? ?? include good manufacturing, good veterinary practice, and good hygienic practice Germicide - any antiseptic or other agent used to ... Agricultural Development Authority (RADA) came on board for its formulation and preparation, and along with the Inter-American Institute for Cooperation on Agriculture (IICA) solidified the document

Ngày tải lên: 05/12/2023, 09:32

... GMP (Good Manufacturing Practices ) Tiêu Chuẩn Thực Hành Sản Xuất Tốt Quá trình hình thành GMP  Năm 1933, Luật ... yêu cầu GMP Trong nông nghiệp GAP ? ?Good Agriculture Practice” – Thực hành nông nghiệp tốt Trong công nghiệp làm tiêu chuẩn GHP ? ?Good Hygien Practice” GPP ? ?Good Pharmacy Practice” – Thực hành ... phải đạt GMP-WHO 1 Khái niệm GMP a Khái niệm GMP Thực hành tốt sản xuất thuốc ( GMP : Good Manufacturing Practices ) hệ thống qui định chung hay hướng dẫn nhằm đảm bảo nhà sản xuất cho sản phẩm

Ngày tải lên: 06/12/2016, 14:00

... presented to the forty-eighth Expert Committee for adoption: 80 Section: Section 2: Section 7: Section 17: Pharmaceutical quality system Good manufacturing practices for pharmaceutical products Contract ... changes, for example, in processes, equipment or packaging materials References Good manufacturing practices for pharmaceutical products In: WHO Expert Committee on Specifications for Pharmaceutical ... inadequate safety, quality or efficacy   Good manufacturing practices for pharmaceutical products, Part One In: WHO Expert Committee on Specifications for Pharmaceutical Preparations Thirty-second

Ngày tải lên: 03/12/2017, 23:59

... assurance For the purposes of this Guide, the terms “current good manufacturing practices? ?? and ? ?good manufacturing practices? ?? are equivalent The Guide as a whole does not cover safety aspects for the ... HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7 ... .39 iv GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing

Ngày tải lên: 04/12/2017, 04:18

... materials for use in the manufacture of finished pharmaceutical products; — intermediates in the manufacturing process (e.g bulk granule); — pharmaceutical products (in-process as well as before and ... material Pharmaceutical product Any material1 or product intended for human or veterinary use presented in its finished dosage form or as a starting material for use in such a dosage form, that ... facility is approved for the delivery of the specified product or service, other procurement agencies are informed of the approval Prequalification is required for all pharmaceutical products regardless

Ngày tải lên: 30/06/2017, 21:31

... Series, No 961, 2011 Annex WHO good manufacturing practices for sterile pharmaceutical products Introduction Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) ... Expert Committee on Specifications for Pharmaceutical Preparations WHO good manufacturing practices for sterile pharmaceutical products General considerations Quality control Sanitation Manufacture ... monitoring of the entire manufacturing process 262 2.4 For injectable products the water for injection and the intermediate, if appropriate, and finished products should be monitored for endotoxins, using

Ngày tải lên: 03/12/2017, 23:59

... of products qi = production quantity for the individual products yi = peak inventory for the individual products t pi = production period for the individual products tci = consumption period for ... Runs for the Multiproduct Case 309 Di = annual requirements for the individual products di = equivalent requirements per production day for the individual products pi = daily production rates for ... individual products - assuming, of course, that pi > di , i = 1, 2, , m H i = holding cost per unit, per year for the individual products Si = setup costs per run for the individual products m

Ngày tải lên: 04/02/2020, 08:53

... Participation is an essential part of (re)construction of public space What is good for children is good for all (design for all) Citizenship starts young Five levels of participation • • • • • Children ... Inclusion Projects Good practices for a wide rage of target groups Lies Lambert Mobiel 21 • Sustainable transport • Mobility management • Wide range of target groups Social Inclusion for M21 • Social ... Acceptability/Accessibility/Affordability • • Information and education for parents and stakeholders Empowerment • • Children can make their own choices => What they don’t know, they don’t ask for Now and in

Ngày tải lên: 15/12/2022, 19:28

... licenses of pharmaceutical products 64 3.1.1 Regulations on parallel imports of pharmaceutical products 64 3.1.2 Regulations on compulsory licenses of pharmaceutical products ... medicines for public health Compulsory licensing is a “magical wand” of Government to force the patentees to decrease the price of products and determine in affordable for community access In the pharmaceutical ... restrictions on pharmaceutical products In relation to patents, the liberalization of parallel imports of pharmaceutical products allows developing countries access to pharmaceutical products at

Ngày tải lên: 13/07/2023, 10:43

... that the impurities may carry forward in the downstream chemistry and/or may react to form new synthetic by -products. If these synthetic by -products are carried forward to the final API, these ... in very good agreement This is used only for estimation since sometimes the ACD prediction of the solubility for the ionized form of bases and acids shows greater deviation than for the ... solubility predicted for the neutral form of the molecules Reaction... upon storage at specified long-term storage conditions in the drug product Therefore, for the drug product formulations, as

Ngày tải lên: 15/12/2013, 12:15

... column chosen for a particular separation depends on the com- pound and the aim of analysis. Pharmaceutical companies may have a pre- ferred list of columns that have good demonstrated performance ... Phase Ideally for a reversed-phase separations, the retention factors (k) for all com- ponents in a sample should lie between 1 and 10 to achieve separation in a reasonable time. For a given stationary ... choice for performing method development.These standard columns could be chosen based on some METHOD DEVELOPMENT CONSIDERATIONS 373 set of internal criteria (ie., chromatographic selectivity for

Ngày tải lên: 15/12/2013, 12:15

... height) for peak B ≤ 1.5 • Tailing factor (5% peak height) for peak A ≤ 1.5 • Rt for peak A must be 12.0 ± 1.3 min • Rt for peak B must be 21 ± 1.0 min • The S/N of the LOQ solution (0.05%) for both ... acetonitrile. The experiments for w w pH 2–4 were performed on day 1, and those for w w pH 5–7 were performed on day 2 (≈36 hr after initial prepa- ration).A further investigation was performed by preparing ... DEVELOPMENT [...]... path for initial mobilephase pH selection In the following case study for this pharmaceutical compound M, the method development scenario and rationale for each iteration

Ngày tải lên: 15/12/2013, 12:15

... them. These products are also called primary prod- ucts, main products, or coproducts. Joint products do not necessarily have to be totally different products; the de- finition of joint products ... Allocation for Joint Products and By -Products Sun, Moon, and Mars... reduction in the Cost of Services Rendered for the main services Separate costs for the two main services for ... Allocation for Joint Products and By -Products 347 EXHIBIT 9–2 Model of a Joint Process Product A is warehoused or sold. Product C is warehoused or sold. Incur DM, DL, and OH costs for joint products.

Ngày tải lên: 18/12/2013, 09:12

... pdf/App_9.pdf#search=‘Biobasic%20and%209906%20and%20henry’ 15 M L Mayer, Selecting filters for chromatographic applications,... at system/column performance and method transfer considerations for pharmaceutical analytes, HPLC 2005 Conference, ... and peak tailing for protonated basic components may be observed while the retention for neutral compounds may decrease Columns for a particular laboratory... peak tailing for protonated ... success for fast and effective method development The general approach for the method... amine, J Pharm Sci 87 (1998), 31–39 5 ICH, Guidance for the Industry: Q3B(R): Impurities in new drug products,

Ngày tải lên: 24/12/2013, 18:15

... three basic types of molecular forces: ionic forces, polar forces, and dispersive forces. Each specific technique capitalizes on each of these specific forces: 1. Polar forces are the dominant type ... process, the optimization of drug synthesis and formulation are performed which eventually lead to a sound and robust manufacturing process for the active pharmaceutical ingredient and drug product. ... metabolism, pharmokinetics, process research, preformulation, and formulation). At each phase of development the analyses of a myriad of samples are performed to adequately control and monitor the

Ngày tải lên: 24/12/2013, 18:15