Solution  BY  Communication  | Language: Chinese
Audit Guide
6.1 Is there a document control system in place ensuring proper design, approval, review, and distribution of necessary documentation?
6.2 Is there evidence that documents are laid out in an orderly manner and with clear and unambiguous content?

6.3 Is every product lot accompanied by a certificate of analysis (COA) or certificate of conformity (COC)?

6.4 Do COAs clearly indicate which tests are performed on every lot and which results are obtained by skip lot testing?

6.5 Does this certificate provide information about the origin of the product?

6.6 Are COAs from original manufacturers checked against agreed specifications?

6.7 Is regulatory and quality information from the manufacturer transferred to customers?

6.8  Is the company able to provide full traceability on product origin?

6.9 Is the company able to provide full traceability in its own operations?

6.10 Is the company able to provide full traceability on product destinations?

6.11 Are distribution records kept for each shipment?

6.12 Are loading/shipment data documented so that details can easily be traced back?

6.13 When new updated information becomes available, is it dispatched in a timely manner?

6.14 Is it ensured that no upgrading of industrial or technical grade products with identical names to food, cosmetic and/or pharma grade products can occur?

6.15 Are labels applied to containers clear, unambiguous, and permanently fixed? Is it ensured that the following information is provided with each shipment, either on the label or on the COA:

6.16 the name of product, including grade and amount?

6.17 the batch number assigned by the original manufacturer or the batch number assigned by the re-packer, if the material has been repacked and re-labelled?

6.18 the retest date or expiry date and storage conditions (where applicable)?

6.19 identification of the original manufacturing site and contact details of the supplier?

6.20 Is the expiry date, re-test date or the shelf-life written on each container (drums, IBCs, bags, etc)?

6.21 - with each sample of a commercialised product?

6.22 - with a first order in a timely manner?

6.23 Are details recorded of the SDS dispatch showing addressee and date?

6.24 Are records and documents for every delivered batch retained for a defined period of time?

6.25 Is it ensured that COAs of the original manufacturer are only used for originally sealed and properly stored products?

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