In-process Checks During Dispensing of Raw Materials

1.0 Objective
To lay down a procedure for In-process checks during Dispensing of Raw Materials.
2.0 Scope
This Standard Operating Procedure is applicable for In-process checks during

Dispensing of Raw Materials to be followed for tablet, capsule, oral liquid, external formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive Warehouse shall be responsible for dispensing of raw materials.
3.2 Officer / Executive Production shall be responsible for checking of dispensed raw materials.
3.3 In-process Quality Assurance shall be responsible for verification of dispensed raw materials.
3.4 Concern Department Head shall be responsible for implementation of this SOP.
3.5 Head QA / Designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
RH : Relative Humidity
No. : Number
w.r.t. : With respect to
BPCR : Batch Production & Control Record
RLAF : Reverse Laminar Air Flow
API : Active Pharmaceutical Ingredient
5.0 Procedure
5.1 Ensure the following points before starting the dispensing activity.
5.1.1 Gowning procedure shall be followed by the personnel working in dispensing area as

per respective SOP, the persons should be wearing the secondary gown,

head gear/ cap, slipper / factory shoe, nose mask, hand glove etc.
5.1.2 Temperature and RH shall be within limit & recorded as per respective SOP.
5.1.3 All the weighing balances shall be calibrated as per respective SOP.
5.1.4 Differential pressure of the all respective area shall be within the limit and

same recorded in respective format/ log book.
5.1.5 Cleanness of the area, the cleaning should be performing as per the respective SOP

and the disinfectant should be applied as per disinfectant schedule.
5.1.6 Generally start the dispensing from excipients material first then active material

and at the end dispenses the colour/ dies.
5.1.7 All the material shall be approved and released by QC department the w.r.t. assay,

LOD/ moisture etc and bearing the green approved label.
5.1.8 The material shall be intact and well pack in polybag inside in container/ bags.
5.1.9 Always used the double poly bags for the dispensing of all excipeint and active materials.
5.1.10 Ensure separate cleaned scoops shall be used for different excipients and API.
5.1.11 Ensure the expiry date of all API as per label claim shall be not less than

the expiry date of product/ batch.
5.1.12 Check that every container/ bag/ package shall be tightly closed

before and after dispensing.
5.1.13 In case of loose containers, check for the weight as per the “Loose container” label

before dispensing.
5.1.14 Selection of the balance shall be based on the right capacity of the balance as per

the required quantity of the material.
5.2 Dispensing of Raw Materials
5.2.1 Ensure the BPCR of product / batch shall be in place before start of dispensing activity.
5.2.2 Following points shall be check before/ during of any batch dispensing:
5.2.2.1 Only one batch shall be dispensing at once and the all material to the batch shall be

collected in staging area before dispensing.
5.2.2.2 All the respective material shall be collected in a pellet in staging area and lock the

area after the collection of all the material for the batch.
5.2.2.3 Take the material one by one in dispensing booth and check the material name,

mfg. date and expiry and batch no. from the original label on container, check the

approved date, retest date, net Quanity, AR No. from the in-house label.
5.2.2.4 On the RLAF and leave ‘ON’ for 30 minutes before dispensing.
5.2.2.5 Open the individual container in the mark zone of RLAF and visualize the

material color, appearance and odour. (If observed any discrepancy in material

appearance then stop the dispensing of the material and inform to Manager QA immediately)
5.2.2.6 Dispenses the required quantity as per the given in BPCR and dispensing

sheet, weigh accurately the material on the calibrated selective balance.
5.2.2.7 Close the container tightly and weight of the remaining material to warehouse.
5.2.3 After completion of dispensing transfer the dispensed material one by one in a

pellet and production check the dispense material and transfer to the staging

area at manufacturing area.
5.2.4 Transfer the remaining material in staging area of dispensing area, check the

close, labeling, intactness condition and transfer back these materials to specified storage area.
5.2.5 Ensure the proper entry in BPCR for dispensed raw materials.

5.3 Dispensing of Sterile Raw Materials
5.3.1 For Sterile Raw Material, the intact container shall be dispensed in blending area.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Warehouse, Production and Quality Assurance.
8.0 History