Publications
-
Why Life Science Manufacturers Do What They Do in Development, Formulation, Production and Quality: A History (single user digital version)
In a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical manufacturing, Lynn Torbeck has created a "must-read" for anyone involved in product development, formulation, manufacturing and quality. Each of the 45 chapters in this book addresses a specific aspect of applied statistics and provides pragmatic applications to such topics as; Can we save the Technical Conference?, %RSD friend, Foe or Faux?, OOS, OOT, OOC and OOSC and more
-
Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing (single user digital version)
Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze the problem and then — the solution.
-
PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications (single user digital version)
This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope. -
PDA Survey: 2014 Visual Inspection (single user digital version)
In August of 2014, the fourth survey in a series of surveys was launched by PDA to better understand and document current industry practices in this important area. Past PDA Visual Inspection surveys in 1996, 2003 and 2008 have provided practical guidance and insight to those working in this field. The purpose of this survey was to document current industry practice for visual inspection of injectable products. -
PDA Technical Report No. 72 (TR 72) Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance (single user digital version)
This report provides guidance on the types of passive systems, including the materials used in their manufacture, characteristics and capabilities of these systems, qualification approach, operational use and reuse, and options for recycling at the end of the systems' life. -
PDA Survey: 2014 Quality Culture Metrics (single user digital version)
This publication presents the results of the PDA Quality Culture Metrics Surveys conducted in September and October 2014. The objectives of this survey were to understand the maturity of Quality Culture in industry at the time of the survey and to identify appropriate attributes of Quality Culture that can be measurable. -
PDA Technical Report No. 71 (TR 71) Emerging Methods for Virus Detection (single user digital version)
Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products and their production processes. -
PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities (single user digital version)
PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified environments. -
Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab (single user digital version)
Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab, a new publication by Lynn Torbeck, answers this call, contributing to an industry/regulatory dialogue and consensus that will serve and benefit all stakeholders, and patients in particular.
This book is for pharmaceutical professionals working in product discovery, development, manufacturing, quality assurance and quality control. It presents a basic introduction to data and Trend and Out-of-Trend definitions, and proposes terminology to clarify the use of the word “control” in several contexts. Outtakes from FDA warning letters, plant audits and investigations for trend and out of trend are presented to highlight the agency’s viewpoint. Helpful graphs, charts and tables are also included throughout the book and in the appendices.
-
PDA Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations (single user digital version)
PDA Technical Report No. 69, (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations presents the current scientific understanding of the causes of and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations. -
Environmental Monitoring: A Comprehensive Handbook, Volumes 4, 5, 6 and 7 (single user digital version)
The "Environmental Monitoring" series edited by Jeanne Moldenhauer, provides guidance through the ins and outs of the multitudinous aspects of compliance. This collection of volumes is a must have for anyone involved with environmental monitoring concerns.
-
Environmental Monitoring: A Comprehensive Handbook, Volume 1, 2 and 3 (single user digital version)
Regulatory bodies worldwide have all established standards and guidelines for environmental control. Unfortunately, the requirements are not equivalent across documents and nations. These three volumes describe methods for developing and operating an appropriate, sustainable microbiological program for production and the laboratory.
-
Environmental Monitoring: A Comprehensive Handbook, Volume 4 (single user digital version)
18008 Environmental Monitoring: A Comprehensive Handbook, Volume 4 (single user digital version) -
Environmental Monitoring: A Comprehensive Handbook, Volume 5 (single user digital version)
This volume adds to the wealth of knowledge provided in the previous volumes by addressing several important issues not previously discussed in earlier volumes. It starts with the requirements and establishment of an environmental monitoring program for the quality control microbiology laboratory. -
Environmental Monitoring: A Comprehensive Handbook, Volume 6 (single user digital version)
An essential addition to this valuable series, Volume 6 offers current information about numerous subjects including E.M. computerized systems, real time clean room monitoring for total and viable particles, validation of a rapid system for E.M. monitoring and water testing, practical and business approaches to microbial IDs, E.M. for non-sterile operations, objectionable microorganisms, neutralization of disinfectants in E.M. media, microbial characterization of E.M. samples and many more topics. -
Environmental Monitoring: A Comprehensive Handbook, Volume 7 (single user digital version)
This volume of the Environmental Monitoring handbook series contains 16 additional chapters, broken out into four topical sections. The first section discusses cleanrooms and ways to prevent contamination. The second section describes various environmental monitoring techniques and methods. Section three explains the changes to standards that occurred for ANSI Standard 29.14 and how this is applicable in pharmaceutical environments. The last section describes new technologies and aides that can be used in evaluating these methods.
-
Microbial Risk and Investigations (single user digital version)
The Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at data that is out-of-specification (OOS). Following issue of this legal decision, many companies and regulators worked to determine how this decision affects microbiological test results.
Microbial Risk and Investigations, written by authors with years of industry experience and edited by industry experts Jeanne Moldenhauer and Karen Zink McCullogh, provides a wealth of information on microbial investigations and dealing with aberrant data. Many of the chapters include case studies that can provide guidance for common situations that may occur at your facility.
Some of the many topics covered include:
- Types of Investigations
- The Microbiologist's Tool Box
- Quality Metrics
- Contamination Risk Evaluation
- Sterility Testing
- Objectionable Organisms
- Particulates
- Rapid Microbiology Methods
-
Computerized Systems in the Modern Laboratory: A Practical Guide (single user digital version)
The bio/pharmaceutical industry is at an interesting crossroads regarding the use of electronic technologies in laboratories. Laboratory management and staff must often evaluate tools that they don’t completely understand, while facing pressure from vendors trying to make a sale. This book provides laboratory staff and managers with a solid understanding of the tools available, how to successfully purchase and implement the technology, and how to develop a plan for application and evaluation in order to meet regulatory requirements.
-
Points to Consider for Aseptic Processing: Part 1, January 2015 (single user digital version)
Points to Consider for Aseptic Processing: Part 1 provides revisions to PDA’s Points to Consider for Aseptic Processing document issued in 2003. These revisions are based on the impact of knowledge gained in the industry as determined by a task force of subject matter experts. -
PDA Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products (single user digital version)
This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifestyle for biotechnology products.
Please sign in or become a member to purchase items from the PDA bookstore.