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From November 2022 through January 2023, the fifth survey in a series of surveys on visual inspection was conducted by PDA to better understand current industry practices in this important area. Past surveys in 1996, 2003, 2008, and 2014 have provided practical guidance and insight to those working …

The 2021 PDA Aseptic Process Simulation for Sterile Bulk Pharmaceuticals Survey was designed to provide insight on current industry practices of the aseptic process simulation (APS) used in the production of aseptically produced sterile bulk pharmaceuticals. There were 42 respondents with the survey …

The 2020 PDA Research Particulate Matter in Flexible Containers Survey was undertaken to address the industry-wide concern raised by multiple recalls for particulate matter in flexible container and other container products dating back to 2012.This survey was conducted to establish a benchmark of current …

The 2021 PDA Post-Approval Change Issues and Impacts Survey provides experts' views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing …

Serialization in the pharmaceutical supply chain is a growing effort to improve shortcomings within the current track and trace processes. The survey will help PDA members, industry, and regulators understand the current state of demand and issues surrounding track and trace and attain additional insight …

This survey is designed to align and expand PDA's insight on current practices for companies that manufacture sterile lyophilized drug products and conduct lyophilizer loading. It also provides insight into how today's lyophilizer loading area operations can be improved to reduce contamination from …

PDA has just released the 2019 Technology Transfer Industry Survey, designed to investigate current practices and learn how companies conduct technology transfers, including their technology transfer processes, knowledge and risk management systems, documentation, and business strategies.More than 250 …

The 2017 PDA Glass Quality Survey is designed to assist in the identification of glass container quality concerns and development of solutions to overcoming them. Survey topics include glass sampling and inspection practices, product complaints and recalls due to glass defects, and quality …

In March of 2017, PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. Due to increased enforcement of section 113 of Annex 1 by …

The 2017 PDA Aseptic Processing Survey explores aseptic processing practices for global secondary manufacturing (finished product filling/packaging), while taking into consideration the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. Results are based on 304 …

PDA's Quality Culture Metrics Pilot Report summarizes the results of 43 participating manufacturing sites in Asia, Europe and North America. Benchmarking data includes site assessment results using the PDA Quality Culture Maturity Model and Tool and is analyzed by geography, product type and business …

Aging facilities contribute to a variety of challenges in pharmaceutical manufacturing, including drug shortages and product recalls. In response to calls for support in this area from industry and regulators, PDA established an Aging Facility Task Force to focus on the identification and modernization …

Due to the lack of detailed guidance and best practices for inspection and particle control in difficult to inspect parenteral (DIP) products, PDA has established a technical report team to address particulate matter in difficult to inspect parenterals. As a first step in developing a better understanding …

Particulate matter in oral dosage forms has been the subject of customer complaints, recalls and regulatory actions. However, there is currently no clear industry standard or guidance on mitigation, acceptance criteria, clinical relevance, inspection, sampling, testing or acceptable complaint levels …

Visual inspection continues to be a critical step in the manufacture and release of high quality injectable medicines. There is limited specific guidance on inspection methods or acceptance criteria which has led to a wide range of industry practices. This diversity is also to be expected given the variety …

This publication presents the results of the PDA Quality Culture Metrics Surveys conducted in September and October 2014. Because similar questions were asked, two sets of results are shown side by side: those from the survey open to all PDA members and those from the survey sent to Heads of Quality …

This benchmarking survey was designed to solicit feedback on and industry status on the application of the principles established in the FDA Process Validation Guidance for Industry of 2011. The survey also investigated how companies are implementing the new lifecycle approach to process validation and …

This benchmarking survey was designed to facilitate the development of a technical report on exclusion of objectionable microorganisms from pharmaceutical and over-the-counter drug products, medical devices and cosmetics. The purpose of this survey was to evaluate how different companies and industries …

Appropriate standards, glass supplier reliability, and pharmaceutical manufacturer handling and distribution best practices are all necessary elements of maintaining container integrity and product sterility assurance throughout the product lifecycle of sterile injectable pharmaceutical and biopharmaceutical …

This 2011 PDA benchmarking survey explores the business case for pharmaceutical quality by examining the cost of poor quality and the essential role of good quality systems in the pharmaceutical industry. The survey was open to the membership of PDA, ISPE and several other industry associations. Included …