Here are some recommendations on how to write Standard Operating Procedures that have a positive impact in operations: 1.
Choose the correct format Depending on the activity, the correct format should be chosen: 2.
SOPs must be current to remain useful as well as to pass an FDA audit or inspection, which can happen without notice.
The most frequently reported deficiencies during FDA inspections are: Failure to pass an inspection will result in a warning letter from the FDA.
Standard Operating Procedures (SOPs) should be tranfered without every modification to insure the expected results.
Every modification or divergence of a given standard, the Procedure should being served, while an investigation and results of the investigation documented according to the internal divergence procedure.
This information will determine if it’s necessary to include basic terminology, pictures, diagrams, etc. Keep the purpose of the Standard Operating Procedure in mind Keeping the purpose in mind will help to include all relevant information.
SOPs distil requirements contained in these documents into a format that can be used by staff members in their work environment.These are some recommendations for writing effective Standard Operating Procedures.What is most important to remember is that these documents need to be comprehensive and easy to read.If they are never read or understood by the intended audience, they are not likely to serve as an effective tool in any process.Standard Operating Procedures (SOPs) help maximum safety and operational efficiency for these kind of organisations: - Pharmaceutical organizations - Government organizations - Emergency response operations - Clinical research organizations - Power producing organizations SOPs are detailed written instructions to achieve uniformity of the performance of a specific function.