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4th EDITION of the REGULATORY COMPLIANCE GUIDE SERIES
(GxP Guides)
GxP Guides Cover US and International Regulations
BioProcess Technology Consultants is pleased to offer an updated series of guides to the US and international regulations governing the research, development, and manufacture of biotechnology and pharmaceutical products, commonly referred to as the “GxP Regulations.” These guides have been in continuous publication for nine years and with this new publication are in their 4th edition, representing the most up-to-date analysis of all the regulations covered.
The BioProcess Technology Consultants guides summarize the latest regulations and guidances issued by the regulatory authorities in the US, Canada, the European Union, and Japan. The guides provide simple and concise interpretation of these regulations and outline effective solutions for their implementation in the development, manufacturing, and clinical environments. The series includes templates for SOPs and other forms that can be copied and used directly. They can serve as manuals for in-house training courses and have been used in the past by several top-tier companies.
Each GxP Guide is available in hard copy only for $499.
Order all 3 guides and save 15%.
Good Manufacturing Practice Guide
This Guide analyzes the contents of the current versions of the Good Manufacturing Practice (CGMP) rules and guidances laid down by the US, the European Union (EU), Canada, and Japan, the guidelines published by the World Health Organization (WHO), and the International Conference on Harmonization (ICH). The chapters of this Guide dealing with compliance take their order of contents from the content pages of the US Code of Federal Regulations #21CFR210-211—the principal GMP rules, and 21CFR600, the general regulations for the production of biologicals. Each topic is covered in turn, with emphasis being placed on the most critical requirements. A set of forms suitable for self-inspections, using as a format the FDA’s “Six Systems” approach, are provided as an appendix. There are also recommendations for dealing with external inspections, at the planning, implementation and follow-up stages. There are sections dealing with the key factors of the inspection of all types of manufacturing facilities, including instructions for staff behavior and the handling of official citations and warning letters. In order to ensure the maximum utility of this Guide, numerous references to Web sites, publications and conferences specializing in GMP compliance and training are provided at the end. Read more....
Good Laboratory Practice Guide
This Guide examines the GLP regulations of the United States and other countries in detail and provides guidelines for compliance, using as a basis the GLP requirements published in the US Code of Federal Regulations, Title 21, Part 58, 2008 Edition. These regulations are intended to assure the quality and integrity of any safety or efficacy data, especially animal testing data, submitted in support of an application to move into clinical trials or for approval to market the new drug. Following this Guide’s recommendations, scientists and managers responsible for academic research, commercial start-up research and development operations, or established industrial laboratories can understand the impact of GLP requirements on their work and assist them in achieving full compliance simply and inexpensively. The recommendations presented in this Guide have been distilled from a large body of information and opinion. The most recent guidelines issued by the FDA and other regulatory authorities to industry and to inspection staff have been referenced. Opinion and advice collected from other regulatory consultants, including ex-FDA personnel, has been reviewed and taken into consideration. A set of forms derived directly from the 21CFR 58 regulations is provided as an appendix. They can be copied directly from the book as needed. Each requirement is covered to ensure that every compliance factor is reviewed. Read more....
Good Clinical Practice Guide
The most time-consuming and expensive task in achieving approval to market a new drug, biological or medical device is to confirm the safety and efficacy of the product by testing it on human subjects. In order to ensure that the clinical trials or studies are performed in a scientific, humane and ethical manner, codes of Good Clinical Practice (GCP) have been drawn up by most countries and are now the subject of international agreement. A clinical study is initiated and monitored by the Sponsor, planned and performed by the Investigator and reviewed and approved by the Institutional Review Board (IRB). This Guide examines in detail the responsibilities and activities of these three main parties and gives practical advice to assist each to fulfill their obligations. To support the work of these three main participants in the clinical study process, numerous forms and check-lists have been prepared and some of them are incorporated into official Guidelines. The most relevant of these have been reproduced in this Guide and may be copied by readers for their own use. The Guide will assist these people to structure and monitor the study so as to ensure its acceptance by the regulatory agencies as being unbiased, accurate and humane. Read more....
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