7.1 Are there written procedures in place for each processing operation?
7.2 Are batches of processed products sufficiently tested for quality and released?
7.3 If hazardous (e.g. toxic, corrosive) products are present on the site, is there a written procedure for segregation or prevention of cross contamination? 
7.4 Is the environment of the re-packaging operation separated from other operations (or at least devoted to compatible products)？ 
7.5 Are there written procedures in place for all packaging and labelling operations?

7.6 Are line clearance checks and label controls carried out to avoid mislabelling?

7.7 Are there appropriate hygiene procedures in place for repackaging operations and repackaging personnel?

7.8 Are written procedures in place to ensure batch homogeneity in case of mixing different batches in tanks/silos?

7.9 Is a sample for retention taken before unloading?

7.10 Can liquid product be filtered prior to the re-packaging operation when required?

7.11 Is there always a representative sample taken after batch mixing?

7.12 Is there always a new batch number assigned in case of batch mixing?

7.13 Is it ensured that analytical data on COAs for mixed batches are always based on new analyses?

7.14 Is each packed lot fully traceable (including the packaging material)?

7.15 Are there packaging and labelling records available for each packaging and/or labelling operation?

7.16 Are samples of each batch of labels kept with the packaging/labelling records?

7.17 Is mixing of lots from different manufacturers avoided?

7.18 Is each lot homogeneous in quality?

7.19 Is there a system in place to prevent mixing of lots that do not conform to the specification with conforming lots?

7.20 Are key point analyses performed for positive identification and detection of evident contamination before unloading?

7.21 Is the product checked and/or tested for quality and identification each time it is transferred from one container to another?

7.22 Are there key point controls performed prior to each packaging process?

7.23 Is it clearly indicated on COAs issued by the distributor on the basis of own analyses, which items are performed on the specific lot and which are created via skip lot testing?

7.24 Is it clearly indicated on COAs issued by the distributor on the basis of own analyses, who performed the analyses and who released the product?

7.25 Is the customer informed when mixed lots are supplied?

7.26 Are the methods used for the analysis clearly indicated on the COAs issued by the distributor?

7.27 Prior to filling, is quality and cleanliness of containers controlled?

7.28 Is there a written report for each cleanliness inspection?

7.29 Is there a system to guarantee compatibility between product and packaging material?

7.30 Is packaging material compatible with the product shelf-life?

7.31 Are container suppliers selected according to quality criteria?

7.32 Are container suppliers qualified and periodically assessed?

7.33 Are container suppliers informed about the sensitive usage of the product?

7.34 Is there an agreement about the primary packaging materials used with the original manufacturers?

7.35 Are there written procedures on product shelf life control?

7.36 Are stability studies carried out in case products are repackaged into container different from the containers used by the original manufacturer when this may be critical to product stability?

7.37 Are the use of reconditioned containers and the re-use of primary packaging materials prohibited?

7.38 In the event of reuse of primary packaging material, is a validated cleaning procedure followed and previous labelling removed?

7.39 Is the environment of the re-packaging operation clean and dust free?

7.40 Is the environment of the packaging operation pressurised with filtered air if necessary for the products?

7.41 Is the re-labelling process consistent with legal requirements and industry standards?

7.42 Is there a review prior to use, of label contents against information from product suppliers?

7.43 Is the name of the original manufacturer mentioned on product labels?

7.44 Are written testing procedures in place for all tests carried out?

7.45 Are all test data recorded and archived in a traceable way?

7.46 Are repackaged batches released by the quality unit or function, independent from operations?

7.47 Are repackaging and quality records reviewed prior to batch release?

7.48 Are only official pharmacopoeia methods or validated analytical test methods used?

7.49 Is each packed lot linked to a retained sample?

7.50 Are retained samples of sufficient size kept for each lot or shipment of repackaged or bulk products for a defined period?

7.51 Are retained samples stored for at least one year after expiry date?