GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004

“Quality Management Systems – Process Validation Guidance”, originally finalized in 1999, is being republished as “GHTF/SG3/N99-10:2004 (Edition 2) ” after revisions due to the changes in ISO 13485:2003, which is utilized in some regulatory systems. The Process Validation Guidance has been
revised in sections 0 through 3.4, Figure 1 and Annex B. The revisions can be generalized in two categories: 1.) Editorial revision of terminology to be consistent with ISO 13485:2003 (i.e., “quality system” to “quality management system” and “design controls” to “design and development
controls”), and; 2.) Changes to Figure 1 and the corresponding text to reflect the new process validation requirements found in clause 7.5.2 of ISO 13485:2003.
This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation and has general applicability to manufacturing (including servicing and installation) processes for medical devices. The guidance
provides general suggestions on ways manufacturers may prepare for and carry out process validations.
Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. This is vitally important if the predetermined requirements of the product can only be assured by destructive testing.
Processing deficiencies may only become apparent after an intermediate component is further processed or the finished product is in use. Validation of a process entails demonstrating that, when a process is operated within specified limits, it will consistently produce product complying with
predetermined (design and development) requirements.

Access entire guidance, clicking here.....