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The term or abbreviation SOP (Standard Operation / Operating Procedure) 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 Operation / Operating Procedure) contains instructions having the force of a directive, covering those features of operations that lend themselves to a definite or standardized procedure without loss of effectiveness. Standard Operating/Operation Policies and Procedures can be effective catalysts to drive performance improvement and improving organizational and operational 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 operation procedures (SOPs). In clinical research, standard operating / operation 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 operations.
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 Operation / Operating Procedure should be available in GMP manufacturing areas for the following systems:
SOP for quality management
SOP for deviation and change control
SOP for training and organization
SOP for complaints
SOP for Recalls
SOP for preventive maintenance
SOP for the release of raw materials and finished goods
SOP for out of specification results
SOP for environmental monitoring
SOP for material management and goods receipt
SOP for pest control
SOP for QC testing
SOP for in process control IPC testing
SOP for document management
SOP for the creation of SOPs
SOP for corrective and preventive actions
SOP for format and content of batch records
SOP for qualification and validation
SOP for setting up product specifications
SOP for supplier qualification
SOP for internal audit or the self inspection program
SOP for lot numbering process
find more examples in our download area.
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