Release of Raw Materials and Packing materials

This Document describes (Standard Operating procedure) SOP for Release of Raw Materials and Packing materials

SOP for Release of Raw Materials and Packing materials

I. Purpose & Scope:

• The purpose of this SOP is to lay down the procedure for Release of Raw Materials and Packing materials
• This Standard operating procedure shall be applicable for Release of Raw Materials and Packing materials required for the manufacturing of products.

II. Responsibilities:

• All Quality control and warehouse personnel’s shall be responsible to follow and implement this SOP i.e. Release of Raw Materials and Packing materials

III : Introduction and Procedural Part :

Procedural part for Release of Raw Materials and Packing materials :

For Release of Raw Material :

• After receipt of Goods receipt note from warehouse; Quality control officer/Executive shall plan for sampling of raw materials as per current version SOP of Sampling of Raw Materials.
• Quality Control Manager or designee shall Plan for testing as per schedule or as per priority.
• He/She shall take up sample for analysis as per specification of the respective raw material.
• Identification test shall be performed on each pooled sample of active material.
• Identification test shall be performed on composite sample of Excipients.
• Quality Control Officer shall check the analysis and compliance of the material to the Respective raw material specifications and report the raw data.
• Any specific non-conformance shall be brought to the attention of Quality Control Manager or designee immediately.
• On completion of the analysis as per the specification, the Completed analytical report (certificate of analysis and record of analysis) shall be reviewed and signed by analyst for accuracy of data.
• Quality control executive or designee (Reviewer) shall review the report, COA and handover to Quality Control Head/designee for approval.
• Ensure all the results are within the specification limits.
• In case the material conforms to specification, it shall be approved and if not, shall be rejected & handle the OOS procedure.
• Quality Control analyst shall write Approved/Rejected labels and shall forward for approval & sign, after verification & approval, values of assay on anhydrous basis and Water/LOD shall be incorporated on Approved Label.
• Quality Control Officer affixes the approved/Rejected label on each container of respective material.
• Approved / Rejected labels shall be affixed in such a manner that word ‘UNDER TEST’ on the ‘UNDER TEST’ label is completely overlapped and the name and batch number on the previous labels are visible.
• Approved analytical report along with GRN, certificate of analysis, record of analysis, Supplier’s certificate of analysis, microbiology reports (if applicable) chronologically as per internal A. R. No. Completed report shall be given to QA department to store in documentation file.
• In case of rejection of material, the copy of certificate of analysis shall be sent to QA.

For Release of Packing Material :

• After Receiving GRN copy of packing material from store to QC; take entry in inward register of packing Material. Assign A.R. Number.
• Quality control person shall draw the sample of the Packing Material as per SOP of “Sampling of Packaging Materials”
• Verify the details of the material with the details available on the Sampler’s Checklist. In case of any discrepancy, inform to QC Head/ Warehouse Head. After sampling kept the sample in quality control packing material drover.
• Quality Control Head/Designee plan for testing as per schedule or priority.
• Quality control officer take a GRN copy along with Supplier certificate of analysis (if applicable) and samplers checklist Perform all the tests mentioned in the respective specifications of the Packaging Material. Record all the Observations on the Record of Analysis sheet/Protocol.
• Attached the specimen sample (control sample) of all printed Packing Material such as labels, cartons, Stickers, Posters, Blister foil, leaflets etc, with the record of analysis sheet. It shall be signed and dated.
• Quality Control Executive shall check the analytical data and compliance of the material to the respective Packing Material specifications. He / She shall get the document. Verified and signed. The document shall consist of sampler’s checklist, analytical data, sheet, specimen sample (Only for Printed Packing Material).
• In case the material conforms to the specification in all respects it can be In case it is not conforming to the specification it will be handled through OOS procedure.
• In case of minor defects in a supply which has not affected the whole consignment and can be separated physically, Stores shall organize to segregate them and QA person shall ensure that there were no mixing of defective item with the good variety after segregation. The defective part shall be rejected and the rest shall be Final approved by QA Manager/Designee.
• Quality control officer/Executive shall write approved/rejected labels and shall forward for approval & sign, after verification & approval, Quality Control Officer/Executive affix the same label on container and affix them on ‘Under Test Label’.
• Approved / rejected labels shall be affixed in such a manner that word ‘UNDER TEST’ on the ‘UNDER TEST’ label is completely overlapped and the name and batch number on the previous labels are visible.
• Approved report file along with GRN copy, certificate of analysis, record of analysis, supplier’s certificate of analysis (if applicable) chronologically as per internal A.R.No. Completed file shall be stored in documentation file.

Release of Raw materials and Packing materials timelines : (For inhouse test)

• Release time line & completion of analysis of Raw Material is within 30 Days after receiving of the GRN copy.
• Release time line & completion of analysis of packing Material is within 30 Days after receiving of the GRN copy.