Writing Deviation Reports – Product Impact Statement

Writing Deviation Reports – Product Impact Statement

By John Lafferty, Life Sciences Programme Director
Read time: 2 minutes

When writing a deviation report, it is important to clearly outline the potential impact on product. Lack of clarity on product impact may delay approval of your deviation report or, worse still, it may delay urgent action required to assure product quality and patient safety. In this article, John Lafferty, our Life Sciences Programme Director outlines the SISPQ method of defining the impact of a deviation on product.

What is SISPQ? 

SISPQ stands for Safety, Identity, Strength, Purity and Quality. US regulation 21 CFR 210.1(a) states “assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess” In order to maintain compliance, document the impact on the product, using the SISPQ method.

The SISPQ method for Documenting the Impact of a Deviation on a Product

Assess and Document the Following;

Safety of the product

• Is product safety affected?
• If not, state the rationale for the claim that product safety is not affected.

Identity of the product

• Has the identity of the product been compromised in any way; is the labelling correct, following the incident? Has there been a loss of documentation or traceability?
• Refer to any reviews of documentation and labelling that have been carried out.
• If labelling and traceability have not been affected, refer to the results of the reviews that demonstrated this.

Strength of the product

• Has product strength been affected?
• Refer to any testing that has been carried out and what the results were.
• If not, state the rationale for the claim that product strength has not been affected.

Purity of the product

• Is there any possibility of foreign matter in the product?
• Refer to any toxicological analysis that has been carried out on foreign matter.
• If purity has not been affected, state the rationale for this claim.

Quality of the product

• Were all process parameters within specification; is there the possibility of adulteration of the product?
• Refer to reviews of batch records and any testing that was carried out.
• If quality has not been affected, state the rationale for this claim.

Learn more about our Technical Writing Skills for Deviations and Investigations  training course https://www.sqt-training.co.uk/programme/technical-writing-skills-for-deviations-and-investigations/

This training course will equip you with the knowledge, understanding, skills and tools to enable you to complete deviation reports and help you to get them approved at the first time of asking.

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About John Lafferty