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Relevant provisions of GMP on drug packaging

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2010gmp provisions on drug packaging
Article 202 the packaging operation procedures shall specify measures to reduce the risk of pollution, cross pollution, confusion or error
Article 203 before packaging, inspection shall be carried out to ensure that the workplace, packaging production line, printing press and other equipment are clean or ready for use, and there are no products, documents or materials irrelevant to the packaging of this batch of products left over from the previous batch. The inspection results shall be recorded
Article 204 before the packaging operation, it is also necessary to check the correctness of the packaging materials received, and verify the name, specification, quantity and quality status of the products to be packaged and the packaging materials used, which are consistent with the process procedures
Article 205 each packaging operation site or packaging production line shall be marked with the product name, specification, batch number and batch production status in the packaging
Article 206 when several packaging lines are packaging at the same time, isolation or other effective measures shall be taken to prevent pollution, cross pollution or confusion
Article 207 the containers to be used for sub packaging shall be kept clean before sub packaging to avoid glass debris, metal particles and other pollutants in the containers
Article 208 the product shall be labeled in time after sub packaging and sealing. If the label is not attached in time, it shall be operated in accordance with relevant operating procedures to avoid confusion or wrong labeling and other errors
Article 209 the information printed separately or online during the packaging process (such as product batch number or validity period) shall be checked to ensure that it is correct and recorded. If it is printed manually, the inspection frequency shall be increased
Article 210 special measures shall be taken to prevent confusion when using cutting labels or printing labels separately outside the packaging line
Article 211 the functions of electronic code readers, tag counters or other similar devices shall be checked to ensure their accurate operation. The inspection shall be recorded
Article 212 the contents printed or molded on the packaging materials shall be clear and not easy to fade or erase
Article 213 during packaging, the intermediate control inspection of products shall at least include the following contents:
(1) packaging appearance
(II) whether the package is complete
(III) whether the products and packaging materials are correct
(IV) whether the printed information is correct
(V) whether the function of the online monitoring device is normal
samples should not be returned after being taken from the packaging production line to prevent product confusion or pollution
Article 214 if the product needs to be repackaged due to abnormal conditions in the packaging process, it must be specially inspected, investigated and approved by the designated person. The repackaging shall be recorded in detail
Article 215 in the material balance inspection, if there is a significant difference in the quantity of products to be packaged, printing and packaging materials and finished products, an investigation shall be conducted, and the finished products shall not be released until a conclusion is reached
Article 216 at the end of packaging, the remaining packaging materials with printed batch numbers shall be counted and destroyed by a specially assigned person and recorded. If the printed packaging materials without printed batch number are returned to the warehouse, it shall be carried out in accordance with the operating procedures.

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