21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

In the FDA regulated environment, it is not acceptable for programmers or their managers to deviate from standardized methodologies. Given the type of software commonly found in FDA regulated operations, the criticality and complexity of computer systems, the evolving regulatory climate, and the current industry best practices, validating computer systems can be problematic. Covering regulatory requirements stipulated by FDA and GAMP guidelines, 21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. Whether you need to validate computer systems for pharmaceutical cosmetic, food, or medical devise applications, this book is indispensable. Discussing the regulatory requirements that are the foundation for any project, the book introduces a model that can be used to determine the Part 11 requirements for consideration during implementation. The book establishes a top-down approach to the integration of computer systems validation strategies in support of a computer systems validation project. It focuses on practical issues in computer systems implementation and operational life project management, including relevant activities to comply with Part 11, validation planning, and scheduling. The book reviews documentation in relation to CSV and procedural controls in regulated operations. The book shows how to enable compliance with computer systems validation requirements while highlighting and integrating Part 11 requirements into the entire computer validation program. The author places regulatory compliance within the context of quality assurance and emphasizes the importance of integrating validation into the system lifecycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.

Validated Cleaning Technologies for Pharmaceutical Manufacturing

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

Validating Medical Packaging

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

Pharmacy Law: Textbook & Review

A concise, two-in-one review of pharmacy law-ideal for coursework and MPJE® exam prep!

This accessible, real-world guide gets you ready for the practice of pharmacy, while giving you the proper training to be compliant with the law. To that end, the book expertly covers relevant laws, rules, and regulations, and it highlights the distinctions between state and federal law where appropriate. In no other reference can you find such a succinct, yet thorough review of the full range of federal pharmacy laws, including the Controlled Substances Act, the Food, Drug, and Cosmetics Act, the new Dietary Supplement Health Education Act, the FDA Modernization Act, and the Medicare Modernization Act.

Features:

* An excellent primer for coursework and unbeatable preparation for licensure and the MPJE®
* Opening chapter on drug regulation and standards provides you with a practical legal framework for subsequent chapter material
* Overview of the drug approval process and federal reporting programs
* Chapter on internet sales and FDA authority to act
* Coverage of opioid addiction treatment and narcotic treatment programs, giving you a unique close-up of the latest laws and policies
* Comprehensive set of 450 multiple-choice questions and answers
* Chapter of MPJE®-format practice questions

Technology Transfer: A Practical Guide

There can be few pharmaceutical companies over the last 15 years that have not undergone the maelstrom of take-overs, mergers, downsizing, centres of excellence or product rationalisation. All these events can, and frequently do, result in product or products being transferred between manufacturing sites. At best it will be a product or product type that the receiving site is familiar with, or at worst, one with which they are totally unfamiliar.
The challenges to effect technology transfer in a timely fashion, within budget and achieving savings that have probably been pre-commirted, at the requisite quality are approximately the same for each aspect. This guide provides a "ready reckoner" of the issues to be considered to achieve these objectives, ensuring that the regulatory issues from both a licensing and inspection
perspective are addressed, and maintaining the organisation's integrity for its products and with its shareholders. In considering the technology transfer process reference is made to the situation within the European Union (EU) in the main; however, where useful guides or proposals are available from other regulatory authorities, notably the FDA, these have been included for completeness.

Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies.

Includes New and Updated Material

Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation.

Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

The Pharmaceutical Regulatory Process, Second Edition

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.