A standard operating procedure (SOP) describes how a routine activity is carried out — cleaning a room, calibrating a balance, investigating an OOS result, releasing a batch. SOPs turn good practice into a repeatable method that every trained person follows the same way.
SOPs are controlled documents. Each has an author, a reviewer and an approver, a unique number and version, an effective date and a periodic review date. When an SOP changes, the old version is withdrawn, staff are trained on the new one, and only then does the new version come into use.
Why it matters in GMP
Every GMP framework — 21 CFR 211, EU GMP Chapter 4, WHO GMP and Revised Schedule M — requires written procedures, followed and documented. Inspectors check that the version in use on the shop floor is the current one, that staff were trained before the effective date, and that superseded copies are out of circulation.
- Separate approval from the effective date, so training can happen in between.
- Keep a controlled copy of each effective version that cannot be altered.
- Link each SOP to the training and the activities that depend on it.
How Swat iQua Suite handles it
In Swat iQua Suite an SOP moves through prepare, review and approve, then a separate make-effective step. Reviewer and approver must differ from the author and from each other, with no admin bypass. Making an SOP effective saves a controlled-copy PDF that cannot be changed, and reprints use that saved copy. An effective SOP prompts a training, trainees read and accept it and take a server-graded exam, and in batch manufacturing a step will not start unless the operator is trained on its linked SOPs.