Follow
1.0 OBJECTIVE
To provide a written procedure to dispense raw materials in specified quantity and to handle the loose materials used for manufacturing of Ophthalmic products in Vision Unit.
2.0 SCOPE
This SOP shall be applicable for dispensing and handling of all active ingredients and excipients in Vision Unit.
3.0 ASSOCIATED DOCUMENTS
3.1 SOP No. IONPM024 Dispensing and Handling of Loose Raw Materials after Batch Accomplishment
3.2 SOP No. VISPM012 Operating and Cleaning Procedure of Dispensing Booth
3.3 SOP No. VISPM013 Operating, Cleaning and Function Checking of Digital Balance
3.4 SOP No. IONPP001 General Packaging Guidelines for ION Products
4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 Sr. Officers/Officers shall be responsible for implementation of the procedure.
4.2 Manager Production or his/her Designee shall be accountable for training and implementation of the procedure.
5.0 ABBREVIATIONS AND DEFINITIONS
5.1 IPA – Isopropyl alcohol
5.2 BMR – Batch Manufacturing Record
5.3 LAF – Laminar air flow
5.4 QA – Quality assurance
6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
6.1 Check carefully the name, lot no. date of expiration of the materials to be weighed.
6.2 Check BMR for the required quantity for each material before weighing.
7.0 PROCEDURE
7.1 Raw Materials Receiving
7.1.1 Assistant Officer shall receive raw materials from Warehouse through Manufacturing Work Order (SOP No. IONPM024) and a print copy of requisition generated in the inventory management system.
7.1.2 Raw materials shall be transferred from Warehouse to the material hoist of vision unit in ground floor using a stainless steel transport trolley. There the outer surface of the container shall be wiped out with 70% isopropyl alcohol solution. Then through the material hoist the container of raw materials shall be taken to the raw material stage. In the raw material stage again the container shall be wiped out with 70% isopropyl alcohol solution and then through pass box the container shall be transferred into the raw material store of dispensing area. If the raw material is sterile, then the container shall be taken from raw material store through the corridor of autoclave and wiped again with 70% IPA and transferred through pass box to the bulk stage of ‘B’ grade area and then it shall be taken in the stage area (room ID VO-13) under laminar air flow where it shall be dispensed. Production & QA Officer shall check that the materials supplied by the Warehouse comply with the materials requested as per manufacturing work order. Record shall be kept of received materials in the log book “raw materials issued / received / dispensed / returned record (SOP No. IONPM024)”.
7.1.3 Production & QA Officer shall check –
the release tag attached with the container
The name of materials and code
R-No of materials
Date of expiration
Retest date
Or any other abnormality in the container before dispensing.
7.1.4 Any fibre drum or paper bag or drum containing raw materials above 10 Kg shall not be taken to the raw material stage or dispensing area of Vision Unit. If these raw materials are required for manufacturing in the Vision Unit, these raw materials shall be dispensed in the dispensing area of ION Unit in the Warehouse as per SOP No. IONPM024 and after dispensing the raw material shall be taken in a SS container and labeled with Product Display label (SOP No. IONPP001), and closed and locked and then transferred to the material hoist of vision unit. In the material hoist the outer surface of the SS container shall be wiped with 70% isopropyl alcohol solution, then through the material hoist the SS container of dispensed raw materials shall be taken to the raw material stage. In the raw material stage again the container shall be wiped out with 70% isopropyl alcohol solution and then through pass box the container shall be transferred into the manufacturing area.
7.2 Dispensing
7.2.1 Raw Materials shall be dispensed under LAF unit in dispensing booth of dispensing area.
7.2.2 The dispensing booth shall be cleaned before and after the dispensing of a batch with 70% IPA. The LAF unit in the dispensing booth shall be switched on at least 30 minutes beforehand of the dispensing activity. Cleaning record shall be kept in the log book (SOP No. VISPM012).
7.2.3 Temperature, Humidity and Differential Air Pressure of the Dispensing Booth shall be checked and recorded properly (SOP No. VISPM012).
7.2.4 The calibration tag shall be checked for calibration validity of the balance. The balance shall be cleaned with 70% IPA solution before weighing. Cleaning record shall be kept in the log book (SOP No. VISPM013).
7.2.5 It shall be ensured that the base of the balances is leveled and stable. If necessary, the level shall be readjusted by rotating leg screws clockwise or anticlockwise before dispensing. The information shall be recorded in a form (SOP no. IONPM024).
7.2.6 The balance shall be switched on.
7.2.7 Daily functional check of balances shall be performed and the results shall be recorded in the log ‘record of functional check of balance’ (SOP No. VISPM013).
7.2.8 Any deviation observed in the functional check shall be notified to Engineering Officer. Engineering Department shall assess the problem and decide repair/readjustment/replacement of parts or equipment. In case of repair/readjustment Engineering Department shall fix the problem and recalibrate the equipment.
7.2.9 The ‘Manufacturing Work Order’ shall be checked for the quantity of the material to be weighed and any calculation done in the ‘Manufacturing Work Order’ shall be checked, then the balance to be used shall be selected depending upon the quantity of material.
7.2.10 Following balances shall be used for weighing of raw materials :
– Balance ID. : VIS-MTE-PR-DS-001 ( Maximum capacity : 620 gm)
– Balance ID. : VIS-MTE-PR-DS-002 ( Maximum capacity : 6200 gm)
– Balance ID. : VIS-MTE-PR-DS-003 ( Maximum capacity : 34 kg)
– Balance ID. : VIS-MTE-PR-SG-004 (Maximum capacity : 620 gm)
7.2.11 The display shall be “0” (Zero). If not make it zero.
7.2.12 The clean pre-sterilized container or poly bag shall be placed on the balance. Printout of the tare weight shall be taken after the displayed weight is stable.
7.2.13 The displayed weight shall be tare or made zero. Another print of zero shall be taken.
7.2.14 Materials shall be taken in the container with a pre-sterilized spatula slowly until the required quantity is displayed. The printout of the net weight weighed shall be taken.
7.2.15 The “Manufacturing Work Order” shall be checked again for the quantity of the materials.
7.2.16 Production Officer and QA Officer shall check all the weighing and keep record of the weighed materials in the “Manufacturing Work Order” and in the log book “raw materials issued / received / dispensed / returned record (SOP No. IONPM024)”.
7.2.17 An identification label “Dispensed Raw material” (Label PM024 – 01) shall be attached on the outside of each container or poly bag of weighed materials. This label must contain the following information:
Name of Material :
R – No. :
Tare weight :
Net weight :
Gross weight :
Material Dispensed for :
Product Name :
Batch No. :
Done by / Date , Checked by / Date and QA checked by / Date
7.2.18 The dispensed materials shall be kept in SS Container properly labeled with Product Display (SOP No. IONPP001), closed and locked and then transferred to manufacturing area. The dispensed materials shall be used within 24 hours from the time of dispensing. If mixing is not started immediately, the S.S. container containing raw materials shall be kept in the dispensing area.
7.2.19 After completion of dispensing the balances shall be switched off and cleaned as per SOP No. VISPM013.
7.2.20 Then the dispensing booth shall be cleaned and switched off as per SOP No. VISPM012.
7.3 Handling Of Loose Containers
7.3.1 After completion of dispensing of raw materials, the inner bag and the container shall be closed properly and the gross weight of rest of the materials shall be taken.
7.3.2 Production Officer shall take the weight in presence of QA Officer.
7.3.3 An identification label ‘Loose Raw Material’ (SOP No. IONPM024) shall be attached to the outside of each raw material containers.
7.3.4 The label shall contain the following information :
Name of material :
R No. :
Date of Issue :
Gross Weight :
Tare weight :
Net weight :
Material dispensed for (Product name, Batch No.).
Done by / Date , Checked by / Date and QA checked by / Date
7.3.5 Production Officer and QA Officer shall sign the label with date.
7.3.6 The container(s) shall be returned to Warehouse or kept in the raw material stage for further use and recorded in the log book “raw materials issued / received / dispensed / returned record (SOP No. IONPM024)”.
