Pharmaceutical Engineering Reader Picks for July

Temperature and Humidity Requirements in Pharmaceutical Facilities

Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements, and strategies for setting limits, can ensure both compliance and optimum use of energy. This article provides guidance on these topics, with supporting rationales. READ MORE

Validation of Aseptic Processes Using Media Fill

Aseptic process simulation (APS) is essential for validation of an aseptic manufacturing process and is required by regulators to demonstrate the aseptic capability of such processes. A successful program of APS and aseptic manufacturing requires significant operator training, skills, and supervision; thorough maintenance; effective cleaning and disinfection; significant oversight of every aspect of the operation by quality assurance; and microbiological monitoring by quality control. READ MORE

Pharmaceutical Cleanroom Design and International Standardization Organization (ISO) 14644-16

Cleanrooms and controlled contamination environments are increasingly being used across many industrial sectors, including the pharmaceutical industry. An important issue is the operating cost associated with cleanroom energy consumption and, consequently, the identification of applicable energy containment measures. This article reviews pharmaceutical cleanroom calculations for non-unidirectional airflow against energy consumption with known sources of contamination and type of air diffusion used. It proposes alternative cases to compare potential economic savings from applying energy-saving measures proposed by ISO 14644-16. READ MORE

Automating Maximum Allowable Carryover (MACO) Calculations in Cleaning Validation

For a multiproduct facility where equipment is shared, there is always a risk from cross-contamination. The correct calculation of the cleaning validation limits from MACO of a marker compound to the next product is vital for the integrity and success of the cleaning validation program. However, the process yielding those limits often involves cumbersome, error-prone manual calculations. Herein, we describe an innovative yet simple tool that uses a combination of spreadsheet software and a statistical platform to fully automate science- and risk-based MACO calculations in pharmaceutical cleaning validation. READ MORE

What You Need to Know About GAMP® 5 Guide (Second Edition)

ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, Second Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. The second edition highlights the use of critical thinking by knowledgeable and experienced subject matter experts to define appropriate approaches. READ MORE

CMC Requirements for New Drug Registration in Latin America

The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America and highlights the divergence of some requirements from harmonized standards like the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). READ MORE

Identifying Out-of-Trend Data In Stability Studies

Drug stability data that deviate from an expected trend when compared to other stability batches or historical data collected during stability studies are considered out-of-trend (OOT) results. According to the US Food and Drug Administration’s “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry,” OOT results should be limited and scientifically justified. READ MORE

Good Engineering Practice in Risk-Based Commissioning and Qualification

Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on engineering and the application of good engineering practices (GEP) to provide documentation for the qualification package. READ MORE

Air Speed Qualification: At Working Position or Working Level?

The European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides background knowledge from literature and data from experiments to enhance the discussion. READ MORE

Evolving China’s Regulatory System in Alignment with ICH

With the Chinese government initiating drug regulatory reform in 2015 and China joining the ICH in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the country. READ MORE