Not seeing the images? Click Here to view in your browser
My Profile | My Products
 
LATEST JVT JOURNAL ARTICLES
FDA 2011 Process Validation Guidance: Process Validation Revisited
This article is based on a technical training seminar presented to United States Food and Drug Administration policy advisors, management, and field staff in Silver Spring, Maryland, in May 2012. It summarizes the regulatory drivers that led to the publication of FDA’s 2011 Process Validation Guidance for industry. In particular, the article emphasizes that process validation is a meaningful scientific endeavor that strives to ensure process control and product quality rather than a discrete and isolated activity. The article proceeds to describe practical steps that product manufacturers can take when applying the Guidance to both legacy and new product manufacturing situations. Read More
 
Methodology for Assessing Product Inactivation during Cleaning Part I: Experimental Approach and Analytical Methods
For multiproduct cleaning validation, the conventional approach for setting an acceptance limit for the process residue is based on the maximum allowable carryover (MAC) of the active pharmaceutical ingredient (API) (depending on the process soil, API refers to the active pharmaceutical ingredient in the drug product, drug substance, or drug substance intermediate). However, if the API becomes pharmacologically inactive during cleaning the acceptance limit does not need to be based on active product. This is an important consideration in biopharmaceutical manufacturing because the cleaning conditions are generally aggressive enough to inactivate the product. Read More
 
A Risk Matrix Approach for Media Simulation Trials
This paper examines the adoption of a risk-based matrix approach for the selection of product simulations used when conducting media filling trials. Media trials are a regulatory requirement for aseptic processing manufacturers. Given that not every product combination can be assessed on multiproduct filling lines, some assessment criteria is required to select the "worst-case" filling run parameters. This paper discusses the main criteria suitable for such an exercise and illustrates the application using a case study. Read More
 
Implementing Variability Reduction Across the Entire Organization
Shewhart’s original ideas on the control of quality were applied to an individual manufacturing process. After Shewhart, his ideas have been applied to a much wider arena than individual manufacturing processes. This expansion in the application of Shewhart’s ideas is important to realize the full benefits of statistical thinking. This must be done in a thoughtful way, so that it is done correctly and without unintended consequences. Read More

LATEST GXP JOURNAL ARTICLES
cGMP Equipment, Instruments, and Calibration
Equipment and instrumentation in facilities governed by current good manufacturing practices (cGMPs) must remain in a validated/qualified state. The site calibration program is a critical part of this effort. Requirements for equipment are stated in Code of Federal Regulations (CFR) Title 21 Part 211.68. General elements of a site calibration program are described. Characterization and classification of site equipment provides the basis for future calibration activities. Risk assessment is critical in this categorization. General program elements are discussed including calibration limits, written requirements, forms, and exceptions. Key points on documentation and records and personnel qualifications are discussed. Developing a calibration program is a significant undertaking best done as comprehensively as possible to avoid redoing classifications and other considerations at later dates. Read More
 
China’s 2011 GMP Regulations–Combatting Poor API/Drug Quality
It is estimated that China manufactures about 80% of the active pharmaceutical ingredients (APIs) imported into the United States and the European Union (EU) for use in the manufacture of finished dosage forms. China is the consumer of over 95% of the finished dosage forms manufactured in the country with most of these dosage units manufactured in locally owned, small, pharmaceutical companies. The Chinese drug market is talked of in superlatives–the biggest and the largest; sadly, when it comes to quality, the superlative “the best” cannot even remotely be applied. Read More
 
Cleaning Validation Residue Limits–How Clean is Clean?
Cleaning residue limits for cleaning validation must be determined based on scientific and technical principles. Fourman and Mullen established the foundation for what has become the standard industry approach to setting limits for residual actives (1). They proposed that equipment be visually clean, that there be no more than 1/1000th of a daily therapeutic dose of active in the maximum daily dose of the next product (safety limit), and that no more than 10 ppm of active be in the next product (default limit). Regulatory agencies have accepted the above approach. A relatively simple strategy and approach to implement this methodology is proposed. A company may choose to implement a cleaning residue alert limit based on past experience with cleaning performance. Analytical methodology used in the above determinations must be validated and have sufficient sensitivity to accurately determine calculated residue levels consistent with required safety limit, default limit, or alert limit acceptance criteria. Companies must determine their cleaning residue limits based on sound scientific and technical data. Read More
 
The Business of Auditing and Auditing the Business: Part V
A quality audit is an important tool for any business to employ. When effectively used as an internal audit, the business will gain greater understanding of its compliance to applicable regulations and internal requirements. Further, the business can critically evaluate the suitability of its procedures and the health of the relationships within its functions. This scrutiny can come with a price. As we see in the story below, stresses and conflicts during an audit can develop. Both the management team and the audit team share the responsibility to ensure that all audit activities remain professional and focused.
Read More
Recommended for you
Variety is the Spice of Life!
The Meaning of "Cloud"
Building Blocks of Quality by Design
2nd Annual QbD
 
As Part of your Membership
Sterility By Design
Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production
Site Validation Master Plan
Master Validation Plan Template
REGISTER SOON!
37TH International GMP Conference
March 11-14, 2013
Co-sponsored by FDA and UGA
Location: Athens, GA
This email was sent by Advanstar
600 Unicorn Park Dr l Woburn, MA, 01801
Manage Preferences l Unsubscribe
Get Connected
 
© 2012 ADVANSTAR COMMUNICATIONS INC. All rights reserved.