What is a Standard Operating Procedure

What is a Standard Operating Procedure
  

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

A SOP (Standard Operating Procedure) contains instructions having the force of a directive, covering those features of Operatings that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating/Operating Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational and Operatingal results. They assure that processes and manufacture will be done in a similar way and lead always to the expected quality of product. SOPs must be followed by operators performing the manufacture and the testing of drugs.

Each efficient quality management system is based on its standard Operating procedures (SOPs). In clinical research, standard operating / Operating procedures (SOPs) are defined by the International Conference on Harmonization (ICH) as \"detailed, written instructions to achieve uniformity of the performance of a specific function\". SOPs are necessary for a clinical research organization whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in clinical research to achieve maximum safety and efficiency of the performed clinical research Operatings.

It is therefore a must that all people and sites involved in clinical studies (both at the sponsor and at the investigative sites) have appropriate SOPs in place in order to conduct clinical research and to ensure compliance with the current regulations. The ICH GCP (good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that an Institutional Review Board (IRB) have its own SOPs or written standard procedures. This it self proves that presence of SOPs are an integral part of the clinical trial at all levels.

The presence of these quality documents is essential when regulatory inspections (FDA, EMEA) take place since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GMP non-compliance is high at organizations with a poor availability of specific SOPs and also if at all they are available the staff or the people for whom they were written are not either following them.

It therefore becomes very important for the personnel to be trained on these SOPs so that they are actually aware of why and how SOPs can play important role in fulfilling the specific regulatory requirements from WHO, FDA, EMEA or other national health authorities.

Health authorities world wide like the FDA or EMEA expect pharmaceutical, cosmetic and food producers to describe their manufacturing processes in written SOPs.

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