Pharmaceutical issuance, coding, reconciliation, and handling of packing components are essential steps in the pharmaceutical manufacturing process. Overall, the issuance, coding, reconciliation, and handling of packing components are critical steps in the pharmaceutical manufacturing process. These steps ensure that all materials/components are tracked, verified, and handled appropriately to ensure product quality, safety, and efficacy. SOP for Issuance, Coding, Reconciliation and Handling of Packing Components is essential to follow established procedures and protocols to ensure that all steps are carried out correctly and that any issues are identified and addressed promptly.
OBJECTIVE:
This Procedure is applied for issuance & coding of packaging components to achieve the following objectives:-
- To fulfill cGMP requirements
- For efficient and smooth operation
- To operate the system for its accountability
- To minimize the wastage of packaging components.
RESPONSIBILITY:
- Section Supervisor
- Production Manager
PROCEDURE:
ISSUANCE OF PACKING COMPONENTS
SOP for Issuance, Coding, Reconciliation and Handling of Packing Components
- Batch Packing Order for packing components is issued by material control department.
- Issuance of packing components is done against assigned quantities of B.P.O. one day in advance.
- GRN number and quantities are entered in B.P.O. by Raw Material & Packaging Material Store Incharge and counter checked by Production Supervisor.
- Packaging components are checked for description. GRN number and issued quantities.
- Issuance is done under the supervision of Production and Packaging Store Supervisors.
- Production and Packaging Store Supervisors will put date & signature on B.P.O. in respective columns.
- Issued quantities are checked by Packing Supervisor for accountability & defects.
- Packing Supervisor will check randomly the bundles of packing components against claimed quantities.
- The whole lots are then stacked as uncoded materials in packaging store against its specific place.
- Transaction of uncoded components for its coding is done under the supervision of production supervisors.
- The transaction is duly signed and logged in the book for its accountability.
Coding of Packaging Components
- Arrange the nylon stamps in advance as per packing schedule provided which had information about B.No., Mfg / EXP Dates and retail price.
- All stamps for the month are over-printed on a separate sheet and this sheet is kept by production supervisor.
- Prior to start the coding for any particular batch, make sure that all stamps are over-printed on the Batch Packaging Order specified for that product.
- Production supervisor will check and sign each stamp being over-printed on the Batch Packaging Order.
- Quality Control Inprocess Supervisor will check and counter sign each stamp over-printed on Batch Packing Order.
- Approved Carton, Label, Inner Pack and Leaflet are attached with Batch Packaging Order as a part of Batch History Record.
- After approval by QC start the regular coding.
- Only one required stamp is kept, while coding the cartons & labels.
- One product is kept & coded in one coding desk.
- Prior to coding each operator is instructed to check each bundle of cartons and labels for its “CODE BAR SYSTEM” Potency and any defect.
- Coded materials are given on lines under the supervision of production supervisor.
- Coded packaging components are stacked in labeled empty shippers / boxes.
- At the end of batch written request will be made to coding section for extra labels or cartons.
- At the completion of batch all stamps which are used for that particular batch either on packing line or in coding section will be submitted to the production incharge, which after its checking will finally be attached with the B.P.O. as a part of Batch History Record.
- This transaction of coded materials is rerecorded and documented in register for its accountability and traceability.
Here’s an overview of each step
Pharmaceutical Issuance: This refers to the process of issuing raw materials or packaging components to the manufacturing process. The issuance process involves the verification of the material or component against the batch record and ensuring that the material/component is not expired or damaged. Issuance is usually controlled through a computerized inventory management system that tracks inventory levels, batch numbers, and expiry dates.
Coding: Pharmaceutical products and their packaging components are usually coded with unique identifiers to ensure traceability and to prevent counterfeiting. Coding can be done using various techniques such as barcodes, QR codes, or RFID tags. The coding process involves assigning a unique code to each product or packaging component, verifying the code against the batch record, and ensuring that the code is legible and can be scanned accurately.
Reconciliation: This refers to the process of verifying that all issued materials/components have been used or returned to inventory. Reconciliation involves comparing the inventory levels recorded in the system with the physical inventory levels. Any discrepancies are investigated, and corrective actions are taken. Reconciliation is an important step in ensuring that all materials/components are accounted for and that there is no risk of cross-contamination or mix-ups.
Handling of Packing Components: This refers to the proper handling of packaging components such as vials, labels, caps, and cartons. Handling includes proper storage, labeling, and transportation of these components to ensure that they are not damaged or contaminated. All packaging components should be handled in accordance with good manufacturing practices (GMP) to ensure product quality and safety.
RECONCILIATION:
- Reconciliation of packaging components is done during coding and online operation, to minimize the wastages.
- After packing the wastage of packing components is calculated on B.P.O.
QUALITY FORMS AND RECORD
N/A
DISTRIBUTION
- Production Manager
- Assistant Manager Production
- Production Pharmacist
- Head of Operations
- QA Manager
- QC Manager