Progress has been made on several projects already, and many will be completed this year. The following section highlights
some of this work.
Q01–Knowledge Capture.
According to ICH Q10, knowledge management is defined as a systematic approach to acquiring, analyzing, storing, and disseminating
information related to products, manufacturing processes and components. It is expected that complex information is captured,
managed, and shared during the product life cycle. The Q01 PCMO technical report focuses on the continuum of data collection
through to understanding of both the process and product and will consider the feedback loop of decision-making. Aspects included
in the draft report include explicit knowledge, converting tacit knowledge (nonwritten personal knowledge of employees), and
the means of capturing knowledge from data interpreted as information. The draft will focus attention on collecting prior
knowledge from experience, which can include experience obtained from similar processes (e.g., internal knowledge, industry
scientific and technical publications), published information (e.g., external knowledge: literature and peer-reviewed publications),
pharmaceutical-development studies (e.g., mechanism of action, structure/function relationships), technology-transfer activities,
and process-validation studies as well as other downstream life-cycle sources. There is much to learn and the technical report
will provide guidance in this regard.
P01–Process Validation and Verification: A Life-cycle Approach.
Great progress has been made by the PCMO Process Validation and Verification task force. As with other PCMO deliverables,
this report focuses on process validation and continued verification, and is being optimized for global use as recommended
in ICH Q8, Q9, and Q10 (the product life cycle). A key task-force goal is to promote the implementation of process-validation
concepts from a practical perspective.
The scope of the PCMO validation technical report includes all drug products included in the FDA January 2011 guidance on
process validation (e.g., pharmaceuticals, both sterile and nonsterile; biologicals, active pharmaceutical ingredients [APIs];
radiopharmaceuticals; and veterinary drugs). It also includes the drug-product component of combinations of drug and medical
device. Consistent with FDA guidance, this technical report will exclude medical devices, dietary supplements, medicated feed
and human tissues, as well as cleaning validation because cleaning is covered in other PDA technical reports (TR-29 and TR-49).
The bottom line is that this technical report is intended to assist in the design and execution of process-validation studies
to ensure the reproducibility and robustness of the processes. The report is not intended to be all encompassing. Other means
of approaches or even traditional process validation may still be applicable in some regions of the world. PDA anticipates
publishing this document at the end of 2011.
P04–Utilization of Statistical Methods for Production and Business Processes.
As manufacturers seek to improve quality, statistical methods have been rediscovered as crucial tools for the successful development
and manufacture of pharmaceutical products. Manufacturers seek to consistently produce products that conform to predetermined
quality characteristics, and statistical methods have shown value in providing objective evidence toward meeting this goal.
ICH, the International Standards Organization (ISO), and the European Union have provided guidance on the use of statistical
methods.
The primary objective of the PO4 task force is to convey the appropriate use (for each application) of statistical methods
at a level that most industry users can understand. The purpose of the technical report is to present relevant and easy to
use statistical process control methods that are applicable to our industry. Advanced statistical methods, such as multivariate
models and design of experiments (DoE), will not be considered. The team has completed its first draft of the technical report
and will begin the final review process in the second quarter of 2011.
R01–Risk-Based Manufacturing.
PDA's 2008 Technical Report No. 44 Quality Risk Management for Aseptic Processes provides an excellent case study for aseptic processes. The PCMO task force on risk-based manufacturing is expanding the
concepts presented in TR-44. Specifically the task force is charged with defining an approach for implementing quality risk-management
(QRM) practices that are grounded in ICH Q9 principles. The task force is divided into four teams that are working on multiple
deliverables, including implementation details for a QRM program for manufacturing operations and specific case studies. This
new content will provide "how-to" details for implementing an integrated QRM program for manufacturing operations.
Additionally, there are three supporting teams developing specific risk-assessment case studies for biotech manufactured APIs,
drug product (liquids and solids), and packaging & labeling. The case studies will use the concepts discussed in the QRM implementation
document and have been selected to illustrate the use of various risk-assessment tools for different types of manufacturing
operations.
To close, the projects highlighted above are expected to conclude this year. As we move into 2012, PDA will have a plan for
bringing to completion additional PCMO projects. We expect to report in more detail on these and other projects in Pharmaceutical Technology in Fall 2011.
Richard Levy, PHD, is senior vice-president of the Parenteral Drug Association (PDA), levy@pda.org
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