The aim of every pharmaceutical operation is to get a product that is safe and effective for the patient on the market. Basement for a high quality product is that all systems and processes to manufacture this product are reliable and able to generate reproducible quality.
Once these manufacturing systems and processes are defined they have to be standardised and described in working instructions and standard operating procedures.
These working instructions and SOPs represent all knowledge that is necessary to run the manufacturing and supporting activities.
Regular training of SOPs assures that employees are well aware about the specific tasks to fulfil their jobs.
Standard Operating Procedures have to be formally reviewed and approved. Once they have been approved they have to be maintained under document control. Not only for the original document. Document control must be applied for any working copy that is distributed to departments or individuals to avoid those old versions are used for current operations.
Authorised copies of SOPs should have an indication “authorised copy” or “controlled copy” to easily differentiate from non-controlled SOP copies.
Obsolete SOP Versions should be archived according to the applicable regulation.
A good practice is to separate system SOPs from operational SOPs, to have an effective overview about the general system procedures, applicable for the whole site.
Copyright 2011 by Standard Operating Procedure