| Starting Material Non-Conformance/Discrepancy Intimation |
1.0 OBJECTIVE To lay down the procedure to communicate the vendor in case of non-conformance/discrepancy observed in starting material (raw & packing) during receipt, analysis, manufacturing / packing operations. 2.0 SCOPE This procedure is applicable to all starting materials used in manufacturing & packing of drug products. 3.0 RESPONSIBILITY • Head Warehouse • Head PPIC/Supply Chain • Manager QA 4.0 ACCOUNTABILITY Head Quality / QA To read this sop Click Here SOP for Gap Analysis 5.0 PROCEDURE 5.1 Discrepancy could be like physical damage, significant variance in Quantity etc. at the time of receiving and non-conforming as per the specification, after testing and / or during usage. 5.2 If any discrepancy found in staring material at the time of receiving, during testing or dispensing or manufacturing concern person shall intimate to their superior. 5.3 In all the cases concerned person shall intimate to their superior. 5.4 Concerned Head shall examine the discrepancy and then intimate to Head-QA for investigation & further action. 5.5 The details of non-conformance/discrepancy shall be logged in format no. XXX and the same shall be reported as per format no. XXX. 5.6 Officer or above of QA department shall assign a non-conforming/discrepancy number as per prototype NCI/YY/NNN. Where, NCI: stands for non-conformance intimation YY: stands for last two digit of year NNN: stands for sequential serial for the current year (e.g. 001, 002, 003….) 5.7 Head-QA shall ask to concern vendor/ supplier for investigation of the discrepancy observed in the material and to submit CAPA as per format no. XXX sending the scanned copy of the same through e-mail. 5.8 After receiving of CAPA from the vendor, Head QA shall verify the appropriateness of CAPA and shall update the non-conformance/discrepancy intimation log (Format no. XXX). 5.9 After verification of appropriateness of the CAPA by Head QA, NCI Report shall be forwarded to Head Quality for final comments & closure. 5.10 Non-conformance / discrepancy intimation log shall be verified monthly for follow up and closure of Non conformance / discrepancy intimation report. |
