Follow
Objective : To provide a written procedure for receiving Raw and Packaging Materials within the material receiving area of Warehouse.
Scope: This SOP shall be applicable for Warehouse and Quality Assurance Department.
Associated Documents
SOP No. IONWH016 Pest Control
SOP No. IONQC033 QC Inspection of Incoming Raw and Packaging Materials
Responsibility
Warehouse personnel shall be responsible to carry out the activity as per procedure.
Warehouse In Charge or his or her nominee shall be accountable to ensure the proper training and implementation of the procedure.
Abbreviations and Definitions
1 Consignment
The quantity of starting material, or of a drug product, made by one manufacturer and supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include material belonging to more than one batch.
2 Raw Material
5.2.1 Active Ingredients
A substance or compound that is intended to be used in the manufacture of a pharmaceutical product as a pharmacologically active compound (ingredient).
5.2.2 Excipient
Any ingredient other than the active ingredient added to a pharmaceutical product to permit it to be formed into the proper shape and consistency; the vehicle for the pharmaceutical product.
5.3 Packaging Material
5.3.1 Primary Packaging Material
Any packaging materials coming into direct contact with a drug product.
5.3.2 Secondary Packaging Material
Any packaging materials other than primary packaging materials. These could be either plain or printed.
5.4 MRR – Material Receiving Report
Precautions
Not applicable.
Procedure
7.1 GENERAL
7.1.1 Incoming Raw and Packaging Materials shall be received in the receiving area of the Warehouse.
7.1.2 Incoming materials then shall be transferred onto internal pallets and kept in assigned area.
7.1.3 If a consignment consists of more than one lot or batch, the containers from different lots or batches shall be placed on separate pallets/boxes.
7.1.4 Each different lot or batch no. shall receive a specific receiving number. Raw material shall be designated by R and Packaging material shall be by P. R or P shall be followed by seven digits. The seven digits are represented as follows:
00 – represents the ID for different units (01 for ION Unit & 02 for INF Unit)
000 – represents the serial number of the material
00 – represents the last two digits of the year
Example –
1. R-0100110 represents the first batch of raw material received in the ION Unit in the year 2010.
2. P-0200110 represents the first batch of packaging material received in the Infusions Unit in the year 2010.
7.1.5 The receiving number of the Warehouse shall continue for consecutive years.
7.1.6 Outside wrappers of bags or packets and outer surface of drums shall be cleaned as necessary in order to remove visible or adhering dirt.
7.2 INSPECTION
7.2.1 Upon receipt of a consignment of material, the Warehouse Personnel shall check all containers/bags/packets referencing to the packaging notes and the consignment notes.
Check shall be done in respect to
7.2.1.1 Suppliers Marking
7.2.1.2 Identification code
7.2.1.3 Packaging
7.2.1.4 Number of lots/batches
7.2.1.5 Lot number of supplier identical to challan
7.2.1.6 Total number of containers/bags/packets
The Warehouse personnel shall check that the received raw materials have at least 50% shelf life by the time the materials received at Warehouse.
In addition to these, each container shall be examined for :
7.2.1.8 Presence of original seals
7.2.1.9 Leakage from lids and seals
7.2.1.10 Evidence of rodent or insect infestation
7.2.1.11 Any water damage
7.2.2 Upon receipt, the Warehouse Personnel shall check and document the weight of raw material containers (Form no. WH003-02) as follows:
Active – All containers in a lot
Excipient – + 1
Exception: Incase of Dextrose and Mannitol, the weight shall be taken as done for excipients.
7.2.2 In case of rodent and insect infestation, the materials shall be handled as per SOP No. IONWH016.
7.2.3 Warehouse Personnel shall report any discrepancy observed during inspection in the “REMARKS” column of the Material Receiving Report (MRR) and in Form no. WH003-01.
7.2.4 In case of shortage, the Warehouse Officer shall also inform Purchase, Accounts and QA through Form No. WH003-01.
7.2.5 After visual inspection, all pallets shall be transferred to the “QUARANTINE” area after affixing ‘QUARANTINE’ label on all containers/bags etc.
7.3 RECEIPT
7.3.1 Each consignment shall be entered into the “Material Receiving Report” as appropriate.
The following information shall be entered :
7.3.1.1 Date
7.3.1.2 R-number ( in case of Raw Materials)
7.3.1.3 P-number ( in case of Packaging Materials)
7.3.1.4 Material name and Code
7.3.1.5 Purchase order number
7.3.1.6 Manufacturer / Supplier
7.3.1.7 Manufacturer’s lot number
7.3.1.8 Total weight received
7.3.1.9 Number of containers
7.3.1.10 Individual quantity in a packet or box (Secondary Packaging Material)
7.3.1.11 Carrier’s name
7.3.1.12 Invoice number ( if applicable)
7.3.1.13 IV number (given by Purchase Department)
7.3.2 The Warehouse Personnel shall send the “Material Receiving Report” to QC.
7.4 QC INSPECTION
7.4.1 On receipt of MRR, the Quality Control Officer shall inspect the material as per SOP no. IONQC033.
7.4.2 Quality Control Officer shall ensure that all pallets are properly labeled and kept in the quarantine area.
7.5 DISPOSITION OF MRR
7.5.1 After receiving disposition from QA, Warehouse personnel shall fill in the released quantity section in the MRR and distribute the MRR as follows:
Warehouse Copy (Pink for Packaging Material/White for Raw Material)
Accounts Copy (Yellow)
Blue Copy (QA)
Green Copy (Purchase)
