What is Standard Operating procedure (SOP) in pharmaceutical industry

Definition Of SOP:

An authorized written procedure giving instruction for performing the operation not necessarily specific to a given product or material but of more general (e.g. equipment, operation, maintenance, cleaning, validation, cleaning of premises, environmental control of sampling and inspection)

• Written SOP defines how things are to be done and provided a basis for training of new or located personnel.
• To ensure best possible medicines be made available to the consumer should fulfill three criteria 
• Right quality  
• Right quantity
• Right price

• SOP are the fundamental aspects of the GMPs – the letter should be ideally define what to be achieve

• SOP provided specific approaches on how to meet the requirement.

• There should be master sop which described the overall procedure how to initiate/ revise a sop, format who should review and approve (with define area of responsibility) frequency of routine review (often every two year, mechanism of issue and replacement of out dated version, training.

 Objective of SOP :

• SOPs help to assure the quality and consistency of the service; 
• SOPs help to ensure that good practice is achieved at all times; 
• SOPs provide an opportunity to fully utilize the expertise of all members of the pharmacy team; 
• SOPs enable pharmacists to delegate and may free up time for other activities; 
• SOPs help to avoid confusion over who does what (role clarification); 
• SOPs provide advice and guidance to locums and part-time staff; 
• SOPs are useful tools for training new members of staff; 
• SOPs provide a contribution to the audit process. 
• SOP improved planning and organization
• SOP reduce introduction of errors and variation in operation. 

Who prepared SOP? :

Concern Department prepare the SOP.