This SOP establishes procedures for documenting corrective and preventive actions that are NOT related to specific lot(s) or batch(es) of production material. In the author’s opinion, corrective and preventive actions related to specific lot(s) or batch(es) should be documented elsewhere, e.g. as a planned deviation (QA-9040) or nonconforming material (QA-9030). Furthermore, calibration failures should be documented as per QA-9020. (The author prefers to use separate SOPs for different circumstances rather than lump them all into the category of “corrective and preventive actions”; this allows the SOPs and data collection forms to be tailored more appropriately for the circumstances.)
This SOP may be used not only for corrective and preventive actions directly related to production (e.g. revising a master manufacturing record or retraining a manufacturing or laboratory employee), but also for a wide variety of other significant remedial actions (whether GMP-related or not) such as changing approved pest control or cleaning chemicals, changing approved sources of analytical standards or other laboratory chemicals, or changing approved providers of computer services or other important services. This procedure may be used whenever management feels it would be advantageous to keep a record of specifically what problems, issues, or concerns have occurred and what changes are being made in response. (Alternately, the company may want to reserve this SOP for use when problems only in manufacturing, packaging, testing, or warehousing indicate that remedial steps are required.)
Examples of issues which might be documented using this SOP include:
- Revising specifications for a raw material, component, or product in response to a specific problem or concern.
- Revising the master manufacturing record or master formula for a product in response to a specific problem or concern.
- Changing the approved vendors or manufacturers for a raw material, component, product, consumable supply, or service, in response to a specific problem or concern.
- Repairing or replacing equipment or facilities in response to a specific problem or concern.
- Retraining an employee in response to a specific problem or concern.
- Revising a standard operating procedure, or implementing a new one, in response to a specific problem or concern.
The report template can be used to record corrective and preventive actions.
The report log can be used to track corrective and preventive actions. 21 CFR §111.75(i) and §111.210(h)(5) only require “Corrective Actions” when raw materials, products, or manufacturing processes fail to meet specifications, but similar procedures and records can be used for other circumstances as well. Details about each CAPA should be recorded on a Corrective and Preventive Action Report.]