sop for handling of rejected material in pharma

1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for handling of rejected/expired material.
2.0 SCOPE
2.1 This SOP is applicable for handling of rejected/expired material
3.0 RESPONSIBILITY
3.1 Asst. Officer or above–Quality assurance-Prepare the SOP and follow-up the SOP accordingly
3.2 Asst. manager –Quality assurance -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head – Quality Assurance /Chief Executive Officer
5.0 REFERENCE(S)
5.1 In-House

6.0 PROCEDURE:
6.1 Rejected/expired/ non-recoverable materials may include, but is not limited to
6.1.1 Bulk material.
6.1.2 Work in process.
6.1.3 Finished goods.
6.2 Situations that may result in the rejection of material should be submitted for review by the all concerned Head of Department.
6.3 In Case of Rejected Raw Material:
6.3.1 On the basis of analytical observation of collected sample of raw material QC personnel will prepare analytical report and affix status label either approved or rejected on all the container of the material and intimated to stores department for the same to take necessary action. COA for rejected material will be sent to stores department.
6.3.2 Stores personnel will shift all the material having rejected label from the under test area to the rejected area, and it will be kept in de-marketed area under lock and key.
6.3.3 Stores personnel will intimate to QA, Production as well as purchase department about the rejected material by sending MRN / COA Xerox copy for the same. GRN for the same.
6.3.4 Deduct the Stock from the Stock of particular material.
6.3.5 All the rejected raw material must be returned to the supplier within 15 days from the date of rejection.
6.4 In Case of Rejected Packaging Material
6.4.1 On the basis of analytical test of collected sample of packing materials, QC personnel will prepare Analytical report and affix status label either Approved or Rejected on all the container of packing materials.
6.4.2 In Case of rejection intimation of the packing material same will be given by QC to stores department to take necessary action. MRN of the same will be rejected and sent to stores department.
6.4.3 Stores personnel will shift all the material having Rejected Label from the Under Test Area to Rejected area and it will be kept in de-marketed area under lock and key. Entry to this room will be restricted.
6.4.4 Stores personnel will intimate purchase department about the rejection of any materials by sending rejected MRN for the same.
6.4.5 Rejected qty. will be deducted from stock of a particular material.
6.4.6 Concerned supplier /party will be intimated about the rejection of relevant packing material through purchase department.
6.4.7 All the lying Rejected packing Material will be destroyed within 7 days with the permission of QA, QC and Purchase.
6.5 If the decision is to reject the material, concerned departmental person shall fill part-I of destruction note cum certificate as par Format and send to QA department.
6.6 Head – Quality assurance shall review the destruction note and report and give approval for destruction of materials and send to Chief Executive Officer for final approval.
6.7 After receiving of signed copy from Chief Executive Officer, QA personnel shall send destruction note cum certificate to concerned department.
6.8 Concerned department shall destroy the material in presence of QA personnel as follows:
6.8.1 Raw Materials return to supplier or, by agreement, or destroyed by chemical (7 % Sodium Hypochlorite / 10% Sodium Hydroxide) and keep for 2 hrs before discarding to the ETP plant or physical (incineration) means as appropriate.
6.8.2 Packaging materials shall be destroyed by shredding or incineration as appropriate. Under no circumstances shall rejected packaging materials be disposed by way of trade or dumping.
6.8.3 Bulk materials may be disposed off to the trade, for non-pharmaceutical use, or shall be destroyed by chemical (7 % Sodium Hypochlorite / 10% Sodium Hydroxide) and keep for 2 hrs before discarding to the ETP plant or physical (incineration) means as appropriate. Under no circumstances shall rejected bulk material be blended with other, approvable lots.
6.8.4 Work in-process shall be destroyed by chemical (7 % Sodium Hypochlorite / 10% Sodium Hydroxide) and keep for 2 hrs before discarding to the ETP plant or physical (incineration) means as appropriate. Under no circumstances shall rejected work in-process be blended with other, approvable lots.
6.8.5 If the finished goods are rejected on the grounds of packaging alone the bulk material or pharmaceutical dosage form may be recovered and re-packed, subject to the approval of the Chief Executive Officer. If the finished goods are rejected in their entirety they shall be destroyed. The bulk material or pharmaceutical dosage form shall be removed from its packaging and destroyed by chemical (7 % Sodium Hypochlorite / 10% Sodium Hydroxide) and keep for 2 hrs before discarding to the ETP plant or physical (incineration) means as appropriate. The packaging components shall be destroyed by shredding, crushing or incineration, as appropriate.
6.9 Approved material for destruction to be destroy in the presence of QA personal and fill part-II of Destruction note cum certificate with sign & date and send to Chief Executive Officer.
6.10 Chief Executive Officer shall sign the certificate and send to QA department for recording.
6.11 Head – Quality Assurance shall conduct an investigation into the cause of the rejection and prepare a detailed report of (probable) causes, together with proposed action to prevent re-occurrence of the rejection.
6.12 Xerox copy of destruction certificate will be distributed to the following authorities or department.
a. WHD
b. QC
c. Accounts
d. Purchase
e. Vendor

7 .0 ABBREVIATIONS

SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
WHD : Ware House Department
8.0 ANNEXURE

Annexure-I