Points to Consider for Cleaning Validation [PDA TR 29]

 

PDA launched the project activities related to the PCMO program in December 2008 to help implement the scientific application of the ICH Q8, Q9 and Q10 series. The PDA Board of Directors approved this program in cooperation with the Regulatory Affairs and Quality Advisory Board, and the Biotechnology Advisory Board and Science Advisory Board of PDA.

Although there are a number of acceptable pathways to address this concept, the PCMO program follows and covers the drug product lifecycle, employing the strategic theme of process robustness within the framework of the manufacturing operations. This project focuses on Pharmaceutical Quality

Systems as an enabler of Quality Risk Management and Knowledge Management.

Using the Parenteral Drug Association’s (PDA) membership expertise, the goal of the Paradigm Change in Manufacturing Operations Project is to drive the establishment of ‘best practice’ documents and /or training events in order to assist pharmaceutical manufacturers of Investigational Medicinal Products (IMPs) and commercial products in implementing the ICH guidelines on Pharmaceutical Development (ICH Q8, Q11), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

The PCMO program facilitates communication among the experts from industry, university and regulators as well as experts from the respective ICH Expert Working Groups and Implementation Working Group. PCMO task force members also contribute to PDA conferences and workshops on the subject.

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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 life cycle using a structured top-down approach. This systematic approach helps you efficiently develop compliant software and maintenance its compliance.

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Control Systems for Heating, Ventilating, and Air Conditioning

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition contains a comprehensive treatment of heating and air conditioning system controls. This book was originally written to provide fundamentals of HVAC control to practitioners who were designing new control systems or maintaining existing control systems. Emphasis on fundamental control system principles along with the psychrometrics of air conditioning processes has remained a focus of the new edition. While control system technology has changed drastically over the years, the fundamentals of controlling heating and air conditioning systems have changed only modestly.

Readers will find that fundamentals of existing control systems remain in this book so that those who need to maintain or troubleshoot systems that are twenty or thirty years old will be able to see what practitioners did during that time frame. In addition the ubiquitous application of digital control technology in very recent times is also described. Note that the fundamental control principles once implemented pneumatically are now being implemented in modern digital computers - software now replaces hardware. Another change since the last addition is a new emphasis on controlling minimum fresh air for validation purposes. New techniques for doing this have been developed in response to ASHRAE Standard 62, "Ventilation for Acceptable Indoor Air Quality," and these methods are included.

Control Systems for Heating, Ventilating and Air Conditioning, Sixth Edition is complete and covers both hardware control systems and modern control technology. The material is presented without bias and without prejudice toward particular hardware or software. Readers with an engineering degree will be reminded of the psychrometric processes associated with heating and air conditioning as they learn of the various controls schemes used in the variety of heating and air conditioning system types they will encountered in the field. Maintenance technicians will also find the book useful because it describes various control hardware and control strategies that were used in the past and are prevalent in most existing heating and air conditioning systems.

Designers of new systems will find the fundamentals described in this book to be a useful starting point, and they will also benefit from descriptions of new digital technologies and energy management systems. This technology is found in modern building HVAC system designs.

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Sterilization Validation and Routine Operation Handbook: Radiation

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook, Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

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The Clinical Audit in Pharmaceutical Development

MORIAH Consultants, Yorba Linda, CA. Addresses current issues and trends in the validation and auditing of a clinical study. Covers the concepts of clinical studies and data verification and validation, including the general concept of Good Clinical Practice (GCPs), monitoring, and the role of agencies.

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British National Formulary 57: March 2009

This is the authoritative guide to prescribing, dispensing and administering medicines for all health care professionals. Nobody working in health care can afford to be without the latest edition of "BNF". Compiled with the advice of clinical experts and continually updated to reflect the latest evidence from all credible sources worldwide, this essential reference provides up-to-date guidance on prescribing, dispensing, administering, and monitoring medicines. Not only does the "BNF" include the widely accepted framework for the drug management of common diseases, it also includes details of medicines prescribed in the UK, with special reference to their uses, cautions, contraindications, side-effects, dosage and relative costs. This allows treatment to be tailored to the individual needs of each patient. Updated in print every six months by an expert team of pharmacists, with guidance and validation from a network of leading clinicians, and oversight by a Joint Formulary Committee with representatives from all spheres of clinical practice. "The BNF" reflects current best practice as well as legal and professional guidelines relating to the use of medicines. As a result it is used widely as a touchstone reference, and cited in Parliaments and courts as a source of authority.

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Real World Drug Discovery: A Chemist's Guide to Biotech and Pharmaceutical Research

Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a basic understanding must somehow be obtained. Even the more experienced scientist can find it frustratingly difficult to get an overview of the many factors involved in modern drug discovery and often only after years of exploring does a whole and integrated picture emerge in the mind of the researcher.

Real World Drug Discovery: A Chemists Guide to Biotech and Pharmaceutical Research presents this kind of map of the landscape of drug discovery. In a single, readable volume it outlines processes and explains essential concepts and terms for the recent science graduate wondering what to expect in pharma or biotech, the medicinal chemist seeking a broader and more timely understanding of the industry, or the contractor or collaborator whose understanding of the commercial drug discovery process could increase the value of his contribution to it.

Key Features:

- Interviews with well-known experts in many of the fields involved, giving insightful comments from authorities on many of the sub-disciplines important to cutting edge drug discovery.

- Helpful suggestions gleaned from years of experience in biotech and pharma, which represents a repository drug discovery "lore" not previously available in any book.

- "Periodic Table of Drugs" listing current top-selling drugs arranged by target and laid out so that structural similarities and differences are plain and clear, with regular updates available at the book's website.

- Extensive use of diagrams to illustrate concepts like biotech startup models, preteomic profiling for target identification, Gantt charts for project planning, etc.

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Principles and Practices of Method Validation Proceedings

Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a larege number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.

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Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.

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Sterilisation of Polymer Healthcare Products

"The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Sterilisation has always been challenging but sterilisation of polymer healthcare products is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This comprehensive reference supplies insights into this developing field.

Sterilisation of Polymer Healthcare Products offers a thorough description of the conventional methods of ethylene oxide, gamma and electron-beam radiation, steam and dry heat sterilisation as well as covering newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam - formaldehyde, peracetic acid, chlorine dioxide and ozone.

With the many possible ways to sterilise healthcare products, and new techniques being developed all the time, the author identifies the variety of factors and functions that must be taken into account, such as the requirement for an understanding of physical, chemical and biological properties, design and manufacturing processes, quality control and regulatory issues.

This book discusses the evaluation of candidate materials and components for compatibility with the different sterilisation methods. From this point methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.

Sterilisation of Healthcare Products is a necessary and worthwhile reference for medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry. It is designed to be of use to anyone already working in the field of sterilisation of healthcare products but it will be equally useful to someone about to start working in the field. "

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Pharmaceutical Engineering - Jan/Feb 2009

Articles:

• Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies
  
• ISPE Update
  
• Classified Advertising
  
• Advertiser’s Index
  
• Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management Using Visible Residue Limits for Cleaning
• Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)
  
• Beyond the Bell Curve: A Report on Managing Capital Project Risk
  

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Ion Exchange and Solvent Extraction: A Series of Advances, Volume 16

Presenting key advancements in the areas of ion exchange and solvent extraction on par with the high-level research consistently related by this series, Volume 16 discusses the ion-exchange isothermal supersaturation technique, metal separation via pH-induced parametric pumping, modeling of ion-exchange kinetics for ultrapure water, ion-exchange properties of engineered carbons and carbonaceous materials, and many more topics.

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Good Design Practices for GMP Pharmaceutical Facilities

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

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Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

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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.

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Analytical Instrumentation: Performance Characteristics and Quality

There is an increasing need for analysts to understand and be able to quantify the performance of analytical instruments, in particular with respect to the following:

* specifying equipment for purchase
* estimating uncertainties in intrumental measurements
* quantifying and demonstrating performance quality

This text links together an understanding of performance characteristics with an appreciation of the limitations imposed by instrument design, leading to the interplay of the validation and qualification processes within quality assurance systems.
A unique framework of topics covers the major instrumental techniques of spectrophotometry, chromatography, capillary electrophoresis, and atomic emission spectroscopy. The use of over 200 questions and answers, together with cross-referencing, helps to develop a thorough understanding of the various concepts that underpin the different techniques.
This book will appeal to a broad range of professional chemists, technicians and students, weither with reference to specific analytical techniques, or within a general course of study in instrumental performance. Analytical Techniques in the Sciences-This series of books provides coverage of all the major analytical techniques and their application in the most important areas of physical, life and materials sciences. Each text is presented in an open learning/distant learning style, in which the learning objectives are clearly identified. The reader's understanding of the material is constantly evaluated by the use of self-assessment and discussion questions.

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Modern Practice of Gas Chromatography

The bible of gas chromatography-offering everything the professional and the novice need to know about running, maintaining, and interpreting the results from GC Analytical chemists, technicians, and scientists in allied disciplines have come to regard Modern Practice of Gas Chomatography as the standard reference in gas chromatography. In addition to serving as an invaluable reference for the experienced practitioner, this bestselling work provides the beginner with a solid understanding of gas chromatographic theory and basic techniques.
This new Fourth Edition incorporates the most recent developments in the field, including entirely new chapters on gas chromatography/mass spectrometry (GC/MS); optimization of separations and computer assistance; high speed or fast gas chromatography; mobile phase requirements: gas system requirements and sample preparation techniques; qualitative and quantitative analysis by GC; updated information on detectors; validation and QA/QC of chromatographic methods; and useful hints for good gas chromatography.
As in previous editions, contributing authors have been chosen for their expertise and active participation in their respective areas. Modern Practice of Gas Chromatography, Fourth Edition presents a well-rounded and comprehensive overview of the current state of this important technology, providing a practical reference that will greatly appeal to both experienced chomatographers and novices.

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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.

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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.

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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.

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