This article describes the shipping qualification process used for the international transport of a vaccine drug substance in flexible containers (FC) from the United States. The drug substance is produced in the US and dispensed into two-liter (2L) FCs. The FCs may subsequently be transported internationally for vaccine formulation and filling into syringes.
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A clear statement of requirements is fundamental to determining what you want and what you need
Write your requirements so they are unambiguous, complete, consistent, and testable
The quality of your computerized system will be a direct result of getting quality requirements written
All...
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Aseptic process simulation (media fills) is the lynchpin of any qualification of an aseptic facility
Aseptic process simulations should be carefully planned to ensure the length of the simulation and the number of manipulations performed during the fill are representative of the actual...
The following key points are discussed in this article:
A validation case study involving fundamental problems in equipment qualification at a drug product packaging facility is discussed.
The original intent of the 21 CFR Part 11, pertaining to the use of electronic records and signatures, was to encourage industry to adopt new technologies, but the regulation turned out to have a totally opposite effect. The revision of its guidance documents and the continuous redirection of this rule do not end the confusion and discussion of...
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There is a right way and a wrong way to control chart
Always start the analysis of data by looking at the trend over time
Make sure that the metric being analyzed is the best way available to represent the direct variation of the system
Data are gold. Make sure you use all the available...
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Selection of individual unit operations for a pharmaceutical water system providing bulk compendial water should be based on a thorough analysis of chemical, microbial, and physical parameters of the feed water supply.
The following key points are discussed in this article:
Quality control (QC) microbiology test data are subject to significant variability, both avoidable and unavoidable
Good microbiological procedures, backed by sound microbiological practices, can serve to minimize avoidable variability
The lab’s standard operating procedure (SOP) system...
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Medical device research and development under the US Food and Drug Administration’s design control requirements is discussed
The majority of serious device problems are introduced during the design and change phases of development
Design control and design history file (DHF) requirements...
The maximum acceptable carryover (MAC) criterion is widely used to set cleaning validation limits for contaminants. It is based on the assumption that all the residual contaminants in the cleaned equipment will carryover into the next batch that is manufactured in that equipment. Thus, the MAC criterion is based on a worst-case mass balance (...
DownloadUnderstanding Biopharmaceutics Properties for Pharmaceutical Product Development and Manufacturing II—...
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Dissolution is an essential step in the drug absorption from solid products. In vitro dissolution is primarily a function of drug solubility, the dosage form design, and the testing methodology and conditions
There are different mathematical models that describe dissolution phenomena...
The following key points are discussed in this article:
Wetting is an important phenomenon in the manufacture of pharmaceutical dosage forms
Wetting is also related to drug dissolution, drug bioavailability and in vivo performance—the efficacy of the drug product
Wettability of a solid is dependent on the nature of the functional groups on...
The following key points are discussed in this case study:
A validation case study involving equipment cleaning and inspection of cleaned equipment is discussed
The event comprised of cleaning multiple equipment per procedure. Manufacturing residue was observed in only one specific piece of equipment after cleaning
The following three issues...
