Instant Template download. Ready to use. Each Standard Operating Procedure Template is FDA and EMEA compliant. Easy implementation due to word template.
The word template can be downloaded immediately!
NEW: Buy Standard Operating Procedure by instant download
Is a written document / instruction detailing all steps and activities of a process or procedure. The proceure should be carried out without any deviation or modification to guarantee the expected outcome. Any modification or deviation should be thoroughly investigated and outcomes of the investigation documented according the internal deviation procedure. All quality impacting processes and procedures should be laid out in a Standard Operating Procedure. They sould be the basis for the routine training program of each employee. Procedures should be regularly updated to assure compliance to the regulatory requirements and the working practice. A minimum review schedule of 3 years is recommended. Changes of these documents are in general triggered by process or procedural changes / adjustments. These changes should be managed by the internal site change control procedure. Part of the activity list of such changes should be to update. Procedures should be in place for all Quality Systems plus the specific operational activities on site. The structure of a procedural System and the total amount of individual documents should be carefully taken into consideration. Too many could lead to a collapse of the whole System. System instructions or directives or policis should be not mixed up to keep interaction between quality systems easy.
The content of a Standard-Operation-Procedure should include the following minimum paragraphs:
Copyright 2011 by Standard Operating Procedure - The movie