SOP content

Why Standard Operating Procedures 

Standard Operating Procedures (SOPs) must be written, approved and followed for any operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient, medicinal product or medical devices to ensure consistent application.

A SOP can represent different forms of Standard Operating Procedures i.e. paper, electronic, hybrids of paper and electronic medium.

SOP Definition

A Standard Operating Procedure (SOP) is an authorised written procedure giving instructions of an standard process, that is not product specific and of general nature (e.g.equipment operation maintenance and cleaning, validation, cleaning of premises, environmental control, sampling and inspection, specific departmental activities, distribution activities). Certain SOPs may be used to supplement product-specific instructions. 

Minimum requirements for SOPs

• The meaning and aim of all signatures on a procedure must be clearly defined. Either closed to the signature or in a separate SOP for documentation management.

• Forms and flow charts are recommended to improve understanding and facilitate use of Standard Operating Procedures. When forms, flow charts and any other attachments are used, they must be either:

  • managed as an integral part of the SOP (i.e. any revision(s) to the forms, flow charts and in general any SOP attachment requires a revision of the Standard Operating Procedure 
  • or follow their own review and approval process. In that case, the impact of any revision of the form, flow chart or attachment on the associated SOP must be evaluated and vice versa.

• Standard Operating Procedures must be written in a language that is understood by site / company personnel.

• Standard Operating Procedures relevant to the activity must be available at the workplaces, as well as the current version of the forms, flow charts or other attachments to be used.

• Measures must be taken to ensure that the copies, which are to be distributed, are identical to the original Standard Operating Procedure and distribution control must be maintained for “approved copies” or “paper copies”.

• A system must be in place to ensure that superceded SOPs are removed and destroyed except for the approved signed originals that are archived according to document retention requirements.

SOP Management

There must be a SOP for the creation and maintenance of SOPs as part of the document management system. This SOP should include at a minimum:

• Format, content and numbering of the procedures

• Purpose and scope of the procedures

• Generation, review and approval of the procedures

• Distribution mechanism for the procedures which includes addressing control of paper copies 

• Training mechanism for new or revised procedures

• Revision, versions and change history of procedures managed by change control 

• Archiving and retrieval of superseded procedures

• Management of forms or record sheets associated with procedures

Standard Operating Procedures should be written in detail so that the govern process is reliably described. Personnel writing or reviewing procedures must have the expertise in the area, function or activity covered in the procedure and training in applicable Good Manufacturing Practice or related regulations. Procedures must be clearly written, understandable by persons who are to follow them, and complete. Procedures must be reviewed, and if necessary revised, at least every three years to ensure that the procedure is still valid. If a revision is not needed the procedure must clearly show that it has been reviewed and its validity extended for another period.