| Handling Of Non-Confirming Material |
1.0 OBJECTIVE: 1.1 To lay down a procedure for Handling of Non-Confirming Material. 2.0 SCOPE: 2.1 This procedure is applicable for Handling of Non-Confirming Material. 3.0 RESPONSIBILITY: 3.1 Head of Production and Quality Control shall be responsible for the handling of non-confirming material. 3.2 Head of Quality Assurance, Quality Control, Production to decide about reprocessing or destruction of Non-Conforming Material and, if possible, conformance of Non-confirming Material of other Pharmacopoeias. 4.0 PROCEDURE: 4.1 For any Non-Conforming material, it shall be quarantined with distinct label ‘HOLD’ by the production personnel and shifted to the designated area. 4.2 Head of Production shall raise a note “Non-Conformance Report” mentioning details and description of non-conformance. 4.3 NCR shall be sent to Heads of Quality Control / Quality Assurance, who shall first investigate the cause of non-conformance, along with Head of Production to evaluate the impact of Non-Confirming material on quality of the product. To Read this SOP Click here SOP for Operation & Cleaning Of Quarantine Storage Tanks. 4.4 It shall also be evaluated if the Non-Conforming In process or Finished Product is rejected as per the pharmacopoeia, conform the requirements of any other pharmacopoeia, and the decision shall be taken accordingly. 4.4.1 Reprocessing of Non-Conforming Material shall be done as per the written procedures provided by concern department and approved by head QA to the cause of Non-conformance. 4.4.2 The NCR shall be sent to Quality Assurance Department for final disposition and shall be done by Head, Quality Assurance or his/her designee. 4.4.3 The non – conforming and non recoverable material shall be destroyed as per production SOP titled “Disposal of Used Aids, Non-Recoverable In process and Finished Products. 4.5 After completion of investigation, each NCR shall be assigned a NCR number by Officer/Executive Quality Assurance duly signed and dated. Each one Non-conformance report shall have a nine-digit number the form NCRXXX/YY, where: NCR : Non-Conformance Report XXX : Serial number of the NCR / : “Slash” YY : Last two digits of the year, i.e. 20 for 2020 A new series of note shall be initiated every new year Quality Assurance shall send a copy of NCR to Heads of Production and Quality Control respectively, for undertaking the necessary action after completion of investigation. The original NCR shall be maintained by Quality Assurance. 4.6 All the Non-conformance report record as per Annexure – I, if required additional page then attach Plain A4 Paper. 5.0 ABBREVIATIONS 5.1 Non-Conforming Material: 5.1.1 Any in-process material not meeting the approved specifications. 5.1.2 Which does not pass when tested against its approved pre-established specifications which do not pass when tested against its approved pre-established specifications? 5.1.3 This passes the specifications but somehow does not fulfill the other GMP requirements. 5.1.4 GMP : Good Manufacturing Practices 5.1.5 NCR : Non-Conforming Report 5.2 Non-Conforming Finished Products: 5.3 Any Finished Product not meeting the approved specifications. |
