Process Validation

Vitamin D and a sunny window shed som light on product stability.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

Madness in March: lost ingredients, missed lot numbers, and a million-dollar photo.

Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning.

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Warning Letter: Southern Meds

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

Extractable and leachable issues should be resolved early in the drug manufacturing process. Open communication is imperative for a successful study.

A particular dermatological product was packaged in a metal tube, which is filled from the bottom.

FDA issues a warning letter to Nephron Pharmaceuticals.

To qualify and validate a pharmaceutical manufacturing facility, one must carefully review the facility design for compliance with good manufacturing practices and manage project scope definition, labor and cost estimating, and master-plan development.These activities, properly implemented, help deliver a validated facility on schedule, at the estimated cost, and with expected quality.

A new oral dosage product was designed as "encapsulated tablets." In production, the drug product was pressed into tablets, which were then fed into a revolving capsule-filling table.

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure.

US District Court Rejects FDA Suit to Block Device Manufacturer

"It was just after FDA had initiated the Pre-Approval Inspection process," reports our GMP Agent-in-Place.

This article provides a PhRMA perspective and recommendations on an FDA guidance currently under development dealing with postapproval changes after the final intermediate of the active pharmaceutical ingredient, i.e., BACPAC II. The concept of a "last true solution" is proposed as an additional point in the assessment of potential risk associated with process changes.

The extensible markup language (XML) format facilitates compliance with FDA's new requirements for prescription drug labeling submissions, improves patient safety, and enhances manufacturing sponsor efficiencies.

Information technology can streamline compliance and increase operational efficiency and quality.

Coordinating validation efforts throughout an organization requires an accurate and timely overview and a validation master plan (VMP).

Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.

Performing studies to mathematically 'correlate' swab and rinse sampling values does not add any value. What's more, do not expect them to mathematically correlate.

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Manufacturers can take steps to establish a regulatory compliance assessment program in their pharmaceutical manufacturing facilities.

It was, our GMP Agent-in-Place recalls, a typical, small, clinical-type facility... managed in the typical, informal way.

Warning Letter: Similasan

Technology's new monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance officer.

The European Commission has released its second report to the Council and European Parliament addressing the developments and implications in patent law concerning biotechnology and genetic engineering. The study, which centres on the patentability of inventions relating to stem cells, concluded that those capable of developing into human beings, totipotent stem cells, are to be excluded from patentability on the Directives' grounds of human dignity.

Our GMP Agent-in-Place at a top-10 pharmaceutical manufacturing firm reports on a spill during the manufacture of a time-release capsule filled with coated beads.