This defines the procedure for testing, Approval & Rejection of all Raw material in Q.C.
2.0 SCOPE :
It covers testing & approval/rejection of all Raw materials.
3.0 RESPONSIBILITY :
Applicable to all Quality control & Quality assurance staff
4.0 PROCEDURE :
4.1 On receipt of sampled raw materials, required quantity shall be taken for analysis as per the respective specification. Remaining quantity is stored as Control Sample.
4.2 Identification test should be carried out for all the individual containers sampled ( for Actives).
4.3 Batch wise analysis shall be carried out as per specification on the pooled sample for the remaining tests (Actives as well as Excipients).
4.4 All raw materials are tested as per the Raw material specification.
4.5 After analysis reports shall be prepared by Chemists. Checked by
Asst. Manager/Executives, approved / rejected as per the results, by Manager - Q.C
4.6 The GRNs shall be approved / rejected by stamping with “PASSED”
or “REJECTED" seal
4.7 The approved GRNs shall be sent to stores.
4.8 Based on the results, Q.C chemist shall affix the green APPROVED”
or a red “ REJECTED” Label on the containers.
4.9 The number of APPROVED/REJECTED label should be quantity equivalent to the No. of containers stated in the GRN and one additional label for affixing on the status card.note: “Approved” label for R.M. should have “USE BEFORE DATE” which indicates time frame with in which when the material is used, the finished product will have 100% shelf life. When material used after “USE BEFORE DATE” the shelf life of finished product need to be calculated and reduced accordingly.
4.10 In case any material is rejected for not complying with the standard specification the goods receiving note shall be sealed as ‘REJECTED’ and copies shall be forwarded to stores and purchase department.
4.11 The GRN copy shall accompany with an intimation letter duly authorised by QC Manager and QA Manager. A copy of intimation letter shall be given to Quality Assurance.
4.12 Purchase shall in turn intimate the vendor asking for investigation and CAP and a copy of the correspondence to the vendor shall be forwarded to the Quality Control Department.
4.13 A copy of investigation and CAP received by purchase department from the supplier shall be forwarded to Q.C.
4.14 The rejection material document shall be compiled with raw material report, copy of intimation to purchase, copy of correspondence from purchase to the vendor and investigation report along with corrective action plan from the vendor.