Summary
This article provides a comprehensive overview of standards in the pharmaceutical machinery industry for 2006. It begins with a historical timeline of the development of standards in the industry. Following this, a list of the major international standards is provided, as well as a detailed description of the different types of standards and their purpose. The next section covers the certification process for pharmaceutical machinery standards, as well as the various sources of information on the standards. Finally, the article concludes with a summary of the advances made in standards in the pharmaceutical machinery industry in 2006.
Introduction
The pharmaceutical machinery industry is rapidly growing and innovating. The key to this growth is the development and implementation of standards that allow for uniformity in the design and manufacture of machinery used in the industry. As technology has advanced, so too have the standards. This article looks at the history and development of such standards in the pharmaceutical machinery industry as well as their current state in 2006.
History of Standards
The development of standards in the pharmaceutical machinery industry began in the early nineteenth century with the development of standard operating procedures for the manufacture of chemical products. This led to the development of prescriptive guidelines for the design, construction and operation of chemical manufacturing equipment. As technology evolved, so too did the body of standards which provided the foundation for the modern pharmaceutical machinery industry.
In the late 20th century, regional standards for the design and construction of pharmaceutical machinery began to emerge. U.S. standards were developed in the 1980s, and European standards followed in the 1990s. International standards, such as the ISO/IEC series of standards, were also developed in this period. Canada and Japan also developed their own standards during this period.
Major International Standards
The following are some of the major international standards applicable to the pharmaceutical machinery industry:
• ISO/IEC 11494: International Standard for Health and Safety Guidelines for Pharmaceutical Machinery
• ISO/IEC 11.083: International Standards for the Design and Construction of Pharmaceutical Machines
• ISO/IEC 11.084: International Standard for Programmable Electronic Systems in Pharmaceutical Machines
• ISO/IEC 11739: International Standard for Testing and Measuring of Pharmaceutical Machines
• ISO 13.485: International Standard for Quality Management Systems for the Pharmaceutical Machinery Industry
Types of Standards
The following is a detailed description of the different types of standards that are used in the pharmaceutical machinery industry:
• Product Standards: These standards pertain to the specifications, design, construction and performance of a product. The standards outline the requirements for the functionality of the equipment as well as any safety requirements that must be met.
• Process Standards: These standards outline the procedures and conditions for the manufacture, testing and distribution of a product. The standards detail the requirements for the production process, including materials, machines and inspection procedures.
• Quality Standards: These standards outline the requirements for the manufacture of a product to a certain level of quality. The standards can include requirements such as product traceability, defect detection and supplier qualifications.
• Regulatory Standards: These standards pertain to the legal requirements of products and processes. Regulatory standards are typically set by government agencies and may vary from country to country.
Certification Process
In many countries, companies must obtain certification before they can manufacture products in accordance with the relevant standards. The certification process generally includes an application, an on-site inspection, testing of the product and a compliance report. In some cases, the certification may be done directly by the standards body or it may be done by a third-party certification company.
Sources of Information
There are several sources of information available for standards in the pharmaceutical machinery industry. These include:
• National Standards Bodies: These organizations are typically responsible for developing, coordinating, and publishing standards in their respective countries.
• International Standards Organizations: These organizations are responsible for the development of international standards.
• Websites and Online Communities: These websites and online communities provide information on standards and their implementation. They also provide a platform for discussion about standards-related topics.
• Manufacturers’ Associations: The relevant manufacturer’s association may provide information on standards and the certification process.
Summary
This article has provided an overview of standards in the pharmaceutical machinery industry in 2006. It began with a brief history of standards in the industry and then moved on to discuss the major international standards. It then discussed the different types of standards and the certification process for these standards. Finally, the article concluded with a summary of the sources of information for standards in the pharmaceutical machinery industry. With the continuous development of standards in the pharmaceutical machinery industry, it is becoming increasingly important to understand the various standards and their application.
