standard operating procedure (SOP)

What is SOP (standard operating procedure) 


Contact me at reet.gmp@gmail.com for further information and requirements


An important aspect of a quality system is to work according to unambiguous Standard Operating Procedures (SOPs).A SOP is a compulsory instruction. If deviations from this instruction are allowed, the conditions for these should be documented including who can give permission for this and what exactly the complete procedure will be. 
The original should rest at a secure place while working copies should be authenticated with stamps and/or signatures of authorized persons.


General requirements of SOP


The SOPs should at least mention:


a. who can or should make which type of SOP;
b. to whom proposals for a SOP should be submitted, and who adjudges the draft;
c. the procedure of approval;
d. who decides on the date of implementation, and who should be informed;
e. how revisions can be made or how a SOP can be withdrawn.


It should be established and recorded who is responsible for the proper distribution of the documents, 
the filing and administration (e.g. of the original and further copies). 
Finally, it should be indicated how frequently a valid SOP should be periodically evaluated (usually 2 years) and by whom. 
Only officially issued copies may be used, only then the use of the proper instruction is guaranteed.
The make-up of the documents should meet a minimum number of requirements:


Each page should have a heading and/or footing mentioning:


a. date of approval and/or version number;
b. a unique title (abbreviated if desired);
c. the number of the SOP (preferably with category);
d. page number and total number of pages of the SOP.
e. the heading (or only the logo) of originals should preferably be printed in another colour than black.


The first page, the title page, should mention:


a. general information mentioned under 2.3.1 above, including the complete title;
b. a summary of the contents with purpose and field of application (if these are not evident from the title); if
desired the principle may be given, including a list of points that may need attention
c. any related SOPs (of operations used in the present SOP)
d. possible safety instructions
e. name and signature of author, including date of signing. (It is possible to record the authors centrally in a register)
f. name and signature of person who authorizes the introduction of the SOP (including date).


The data which should be stored per document are:


- SOP number
- version number
- date of issue
- date of expiry
- title
- author
- status (title submitted; being drafted; draft ready; issued)
- department of holders/users
- names of holders
- number of copies per holder if this is more than one
- registration number of SOPs to which reference is made
- historical data (dates of previous issues)
The SOP administrator keeps at least two copies of each SOP; one for the historical and one for the back-up file. This also applies to revised versions. Superseded versions should be collected and destroyed (except the copy for the historical file) to avoid confusion and unauthorized use.




Contact me at reet.gmp@gmail.com for further information and requirements