Compliance

In my last post, I described the GMP requirements for document control. In this post, I am going to describe the GMP requirements for information technology used in a GMP company.   For a drug to be produced in a GxP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements. Read more

In the regulated environment, the document control is the cornerstone of the quality system. It is so important that if an external audit identifies deficiencies in the document control system, the entire organization can be shut down.   In my last post, I talked about the connection between ISO 9001 and document control. ISO 9001 is one example of the regulated environment. It is usually used in engineering types of companies. In food, drugs, medical devices, and cosmetics industries, GxP/GMP regulations are used. Today, I am going to talk about the connection between GxP/GMP and document control. Read more

ISO 9001 specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.   An organization is required to establish, document, implement, and maintain a quality management system and continually improve its effectiveness.   A cornerstone of the QMS is document control. Therefore, in order for an organization to meet ISO 9001 requirements, it must have a document control system in place. Auditors pay particular attention to document control.   Document control is an essential preventive measure ensuring that only approved, current documents are used throughout the organization. Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, and customer satisfaction. Read more