cGMP Articles

After the State Drug Administration (SDA) was established in 1998, it took a firm hand in supervising China's pharmaceutical industry. SDA decided that all pharmaceutical manufacturers must meet GMP standards and obtain GMP certification before June 30, 2004. Since that time, guidances for the following products have been developed:

* biological products and blood products (Dec. 31,1999);
* powders for injection and infusion (Dec. 31, 2000);
* injectables (Dec. 31, 2002);
* all products (June 30, 2004).

Kong Liang

Particularly in the fields of cleanroom technology and sterile products manufacturing, good manufacturing practices (GMPs) regulations and guidances and technical cleanroom standards are mutually dependent on each other. The classification of air cleanliness specified in the International Organization for Standardization (ISO) 14644-1:1999 (1, 2) is quoted as a tool in Annex 1 of the European Union (EU) GMPs (3) and in the US Food and Drug Administration's 2004 aseptic processing guidance (4). The mutual dependence of GMPs and cleanroom standards is clear in that the ISO cleanroom standards are not application specific. The standards don't advise which levels of cleanliness are applicable to specific processes. Similarly, the EU GMPs do not explain how to measure airborne contamination or how to classify a controlled environment.

Driven by tough FDA enforcement, attention to GMP compliance is at an all-time high. In addition to having the responsibility for complying with increasing regulatory requirements, pharmaceutical manufacturers must find ways to improve their productivity.As a result
of mergers and acquisitions, worldwide markets, and the complex nature of drug development, the need for cost-effective global compliance has never been more important. FDA itself has acknowledged the changing times and has been working with industry to support new technologies for safe and cost-effective compliance. Two such initiatives are the electronic

The use of isolation technology in the United States and Europe is beginning to show signs of widespread acceptance and growth.With the increased use of isolators for critical processes comes a demand for better and quicker decontamination methods. Fueling the growth of chlorine dioxide (CD) in the pharmaceutical and medical device industries are its properties as a true gas at ambient temperatures, its capacity to be unaffected by temperature variations and gradients, and its tight process consistency because concentrations can be precisely monitored and controlled. CD properties and background CD is a single-electron, transfer-oxidizing agent. The gas has a chlorine-like odor and a green–yellow color, which enables it to be monitored with an ultraviolet (UV)–vis spectrophotometer. This monitoring can help provide tight process control of the decontamination cycle from beginning to end.

The evaluation of airborne microorganisms is critical in the biopharmaceutical industry. For manufacturers that produce drugs in an aseptic environment, cleanrooms must meet strict standards. Regulatory requirements such as the US Food and Drug Administration’s Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice and internal corporate policies require monitoring to verify that these standards are maintained. Cleanroom monitoring is dependent upon reliable instruments that are suitable for sampling airborne contaminants in an aseptic environment. These instruments must also be calibratable, portable, and easy to use. In this study, three active air samplers were evaluated for the collection of culturable airborne microorganisms. Bioaerosol collection includes whole microorganisms as well as fragments, toxins, and particulate waste products from all varieties of living things (1).

Combination medical products are hot and becoming hotter. In January, the Food and Drug Administration made headlines by quickly approving a fixed-dose-combination (FDC) treatment for AIDS under a new policy that allows its use in developing nations. Pharmaceutical manufacturers also are building commercial markets at home by developing FDCs offering clinical benefits and/or reduced risk while also improving patient compliance and extending the life cycle of established therapies. A related FDA initiative clarifies regulatory policies for products that combine drugs, biologics, and medical devices and thus are regulated by multiple agency centers. FDA’s Office of Combination Products (OCP) is crafting rules and guidances to govern which FDA center will lead the regulation of new combinations and what manufacturing and compliance policies will apply.