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Pda Technical Report No 29.pdf
The 2012 revision of Technical Report 29 builds on the 1998 report and utilizes principles and specific wording from the 2010 PDA Technical Report No. 49, Points to Consider for Biotechnology Cleaning Validation. It presents updated information that is aligned with lifecycle approaches to validation and the International Conference on Harmonisation (ICH) guidelines Q8 (R2) - Pharamaceutical Development, Q9 - Quality Risk Management and Q10 - Pharmaceutical Quality System. Also, this report aims to assist readers who want to create or benchmark a cleaning validation program for their equipment and facilities.
Written by a Task Force composed of European and North American professionals from pharmaceutical manufacturers, cleaning chemical suppliers, and consulting companies, the report has undergone a global, technical peer review to ensure concepts, terminology, and practices presented are reflective of sound science and can be used globally.
The PDA published the Technical Report No 29 on "Points to Consider for Cleaning Validation" as early as 1998. This report has now been published again in an updated version. With this revision its content increased from originally 23 pages to now 95 pages.
Surprisingly short is the chapter Documentation (chapter 9). It contains only 5 pages and one page with flowcharts. Although it is no regulatory requirement, the authors of the revised Technical Report 29 recommend nevertheless compiling a cleaning validation master plan (or a comparable document). On one DIN A4 page a lot of bullet points are listed that present possible points of content of the cleaning validation masterplan. The Report also addresses the harmonisation of cleaning programmes for different sites. Both topics are also discussed in the TR 49 "Points to Consider for Biotechnology Cleaning Validation". A documents flowchart illustrates which documents must be created in which part of the life cycle and the chronology of the documents. The chapter also presents examples for contents of a validation protocol; in this chapter referred to as "process performance qualification (PPQ) protocol ". Interestingly, the Report mentions in this context not only commissioning documents but also IQ and OQ protocols and reports as part of the process validation. Substitution of IQ/OQ-activities by verification, as favoured by the ISPE (see GMP-News dated 25 November 2009 and 21 March 2012 ) is not explicitly mentioned although the ASTM Guide E 2500 on this topic is listed under the chapter "Suggested Readings" (chapter 13). It is mentioned explicitly that the number of runs should be based on cumulative knowledge from the development of cleaning processes and from qualification stages but not on a statistical evaluation.
Cleaning-validation protocols, like process-validation protocols, should include purpose, scope, responsibilities, applicable products and equipment, cleaning standard operating procedures, acceptance criteria, and a requirement for a final report. Key technical elements include residue limits, sampling procedures and analytical methods.
Quality risk management (QRM) involves elements of risk assessment, risk control, and periodic review to ensure continuous and effective control (6). It is important to achieve a shared understanding of the application of risk management among diverse stakeholders. Successful implementation of QRM requires support of the whole team, including operations, technical services, engineering, quality control, quality assurance, and regulatory personnel. This support is essential to identifying and addressing conditions that affect CPPs and CQAs for the cleaning or manufacturing process.
Quality manual inspection is essential in situations where the use of a fully automated inspection system is not practical. Hopefully, the top manufacturers of automated inspection systems will manufacture systems in the future that are suitable for small sized operations, small-scale batches and have a smaller footprint to fit into available space. A majority of companies that participated in the PDA survey reported that they use manual data to validate automated inspection systems. For this reason, manual inspection data must have minimal variation if it is to be used as a baseline for the validation of an automated inspection system.
This report gives guidance on how to perform a Low Endotoxin Recovery (LER) study and shows mitigation strategies of endotoxin masking in biologics. Additionally the report is a good source of background information on bacterial endotoxin testing.
This article discusses two of the most commonly used terms used in cleaning validation: the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). Both the MAC and MSC are the initial values calculated in the overall calculation of cleaning validation acceptance limits for each individual swab or rinse samples or for a visual inspection. In this article we will demonstrate how only the MSC embraces the risk-based approach to cleaning validation demanded by regulatory guidelines and standards. Below, we provide the historical development of both terms and the technical basis for this position.
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This full text file contains reports, issued weekly during the growing season (April to November), which lists planting, fruiting, and harvesting progress and overall condition of selected crops in major producing states. The data, summarized by crop and by state, are republished along with any revisions in the Weekly Weather and Crop Bulletin. During the months of December through March, the report is issued monthly titled State Stories. 2ff7e9595c
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