The term or abbreviation SOP - Standard Operation Procedures is widely used but specifically in the manufacture of drug products, APIs (Active Pharmaceutical Ingredients), biologics, devices and the food and cosmetic industry.

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.

Standard Operating Procedure (SOP)
An authorized written procedure giving instructions for performing operations not necessarily specific to a given product or material but of a more 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 master and batch production documentation or distribution records. 

Standard Operating Procedure (SOP) Management 

A formal program at a site to ensure development, maintenance and archiving of SOPs for compliance to GMPs.

The Site Management Team must ensure that there are systems for creating, approving, maintaining and archiving Standard Operating Procedures for those
activities that may impact the safety, quality, purity and efficacy or distribution of active pharmaceutical ingredient or medicinal product.

Site Management must ensure that there is a system in place for training personnel on the Standard Operating Procedures applicable to their area of responsibilities.

The Site Quality Manager must approve all systems for creating, approving, and maintaining Standard Operating Procedures.

The site Quality Manager is responsible for approving or rejecting all site procedures that may potentially impact on the identity, strength, quality and purity or distribution of active pharmaceutical ingredient or medicinal product.

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 the user.

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 superseded SOPs are removed and destroyed except for the approved signed originals that are archived according to document retention requirements.

There must be systems and procedures for Standard Operating Procedures that must
include at a minimum:

• The format, content and numbering of the procedures
• The purpose and scope of the procedures
• The generation, review and approval of the procedures
• The distribution mechanism for the procedures which includes addressing control of
• paper copies
• The training mechanism for new or revised procedures
• The revision, versions and change history of procedures managed by change control
• The archiving and retrieval of superseded procedures
•  The management of forms or record sheets associated with procedures

Standard Operating Procedures must be written in sufficient detail so that the govern process is reliably repeated using only the procedure and attachments.

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 two 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.

A minimum set of Standard Operating Procedure should be available in GMP manufacturing areas for the following systems:

Quality management
Deviation and change control
Training and organization
Complaints
Recalls
preventive maintenance
The release of raw materials and finished goods
Out of specification results
Environmental monitoring
Material management and goods receipt
Pest control
QC testing
In process control IPC testing
Document management
The creation of SOPs
Corrective and preventive actions
Format and content of batch records
Qualification and validation
Setting up product specifications
Supplier qualification
Internal audit or the self inspection program
Lot numbering process