Title Page
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Auditee's signature : I agree with the audit findings
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SOI<br>Specifications shall exist for raw materials (including primary packaging), finished products and any product or service which could affect the integrity of the finished product.
3.6.1 Specifications for raw materials and primary packaging
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Specifications for raw materials and primary packaging shall be adequate and accurate and ensure compliance with relevant safety and legislative requirements.
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The specifications shall include defined limits for relevant attributes of the material which may affect the quality or safety of the final products (e.g. chemical, microbiological, physical or allergen standards).
3.6.2 Specifications for all finished products.
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Accurate, up-to-date specifications shall be available for all finished products. These may be in the form of a printed or electronic document, or part of an online specification system.
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They shall include key data to meet customer and legal requirements and assist the user in the safe usage of the product.
3.6.3 Formal agreement of the finished product specifications for customer branded products.
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Where the company is manufacturing customer-branded products, it shall seek formal agreement of the finished product specifications. Where specifications are not formally agreed, the company shall be able to demonstrate that it has taken steps to ensure formal agreement is in place.
3.6.4 Specification review
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Specification review shall be sufficiently frequent to ensure that data is current or at a minimum every 3 years, taking into account product changes, suppliers, regulations and other risks. Reviews and changes shall be documented.
- Compliant
- Minor
- N/A
- Major
- Critical
