1.0 OBJECTIVE:
1.1 This SOP shall define the procedure for controlled issuance of materials to production and controlled dispatch of finished goods to ensure traceability, prevent mix-ups, and maintain compliance with Good Manufacturing Practices.
2.0 SCOPE:
2.1 This SOP shall be applicable to:
2.1.1 Issuance of raw materials
2.1.2 Issuance of packaging materials
2.1.3 Dispatch of finished goods
2.2 stored and handled in:
2.2.1 Raw Material Warehouse
2.2.2 Packaging Material Warehouse
2.2.3 Finished Goods Warehouse
3.0 RESPONSIBILITIES:
3.1 Warehouse In-Charge shall ensure proper control of issuance and dispatch activities.
3.2 Stores Personnel shall perform issuance and dispatch as per this SOP.
3.3 Quality Assurance (QA) shall authorize release status and monitor compliance.
4.0 DEFINATIONS:
4.1 Issuance: Issuance is the controlled process of supplying approved materials from the warehouse to authorized production areas against an approved document.
4.2 Dispatch: Dispatch is the controlled process of releasing approved finished goods from the warehouse to authorized distributors or customers.
5.0 PROCEDURE:
5.1 General Requirements:
5.1.1 Only materials and finished goods with Approved status shall be issued or dispatched.
5.1.2 Issuance and dispatch shall be performed only against authorized and approved documents.
5.1.3 Traceability shall be maintained at all times.
5.1.4 FIFO with expiry-based priority (where applicable) shall be followed.
5.2 Issuance of Raw and Packaging Materials:
5.2.1 Materials shall be issued only against:
5.2.1.1 Approved Material Requisition Note (MRN)
5.2.1.2 Production order or Batch Manufacturing Record (BMR) reference
5.2.1.3 Requisition shall be verified before issuance.
5.3 Pre-Issuance Verification:
5.3.1 Before issuance, stores personnel shall verify:
5.3.1.1 Material name and code
5.3.1.2 Batch / Lot number
5.3.1.3 Status label (Approved)
5.3.1.4 Expiry date (if applicable)
5.3.1.5 Quantity required
5.4 Issuance Process:
5.4.1 Required quantity shall be dispensed or issued carefully to avoid damage.
5.4.2 Issued quantity shall be recorded in the relevant issuance register.
5.4.3 Remaining quantity in partially used containers shall be resealed and relabeled.
5.4.4 Issued materials shall be transferred to production through designated routes.
5.5 Handling of Returned Materials from Production:
5.5.1 Unused materials returned from production shall be clearly identified.
5.5.2 QA shall evaluate the returned materials before re-stocking.
5.5.3 Returned materials shall not be re-issued without QA approval.
5.6 Dispatch of Finished Goods:
5.6.1 Finished goods shall be dispatched only after:
5.6.1.1 QA release authorization
5.6.1.2 Availability of approved Certificate of Analysis (COA), where applicable
5.6.1.3 Approved dispatch order / invoice
5.7 Pre-Dispatch Verification:
5.7.1 Before dispatch, stores personnel shall verify:
5.7.1.1 Product name
5.7.1.2 Strength
5.7.1.3 Batch number
5.7.1.4 Quantity
5.7.1.5 Expiry date
5.7.1.6 Packaging integrity
5.7.1.7 QA release status
5.8 Dispatch Process:
5.8.1 Goods shall be packed securely to prevent transit damage.
5.8.2 Transport conditions shall be appropriate for product stability.
5.8.3 Dispatch details shall be recorded in the Finished Goods Dispatch Register.
5.8.4 Traceability of dispatched batches shall be maintained.
5.9 Control of Rejected, Returned, or Recalled Goods:
5.9.1 Rejected goods shall not be dispatched.
5.9.2 Recalled goods shall be segregated and secured.
5.9.3 Market returns shall be assessed by QA prior to any decision.
5.10 Precautions:
5.10.1 Mixing of batches during issuance or dispatch shall be strictly avoided.
5.10.2 Expired materials or finished goods shall not be issued or dispatched.
5.10.3 Unauthorized access to dispatch area shall not be permitted.
5.11 Deviation:
5.11.1 Any discrepancy in quantity, batch, or documentation shall be reported immediately to QA.
5.11.2 Deviations shall be documented and investigated.
5.11.3 CAPA shall be initiated where required.
5.12 Training:
5.12.1 All warehouse personnel involved in issuance and dispatch shall be trained on this SOP.
5.12.2 Training records shall be maintained.
6.0 REFERENCE:
6.1 WHO TRS 961, Annex 2
6.2 WHO Good Storage Practices
6.3 EU-GMP Part I, Chapter 3 & Chapter 5
7.0 RECORDS:
Sr No. Title Document No.
NA NA NA
8.0 REVISION HISTORY:
Amendment Date: Update Summary Version No.
NA New SOP 01