Standard Operating Procedure - SOP

GMP SOP Definition

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.

Training Program for Standard Operating Procedures

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.

Quality System & Standard Operating Procedure

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.

Standard Operating Procedure

How to build a Standard Operating Procedure Template | SOP template?

The content of a Standard-Operation-Procedure should include the following minimum paragraphs:

  • Header with titel
  • regulatory basis
  • reference documents
  • purpose
  • scope
  • responsibilities & accountabilities
  • quality assurance
  • functional units
  • procedure
  • layout and format
  • numbering system
  • page header
  • first page
  • table of content
  • content
  • creating and issuing a procedure
  • reviewing
  • signing and approving
  • retention time and archiving