Dispensing Procedures of Raw Materials

 

1.0     Purpose

1.1      To lay down a procedure for dispensing of raw material as per the requirement from production department.

 

2.0     Scope 

2.1          This SOP shall be applicable for all raw materials, which are dispensed for production at NAME”  Pharmaceuticals Ltd.

 

3.0     Responsibility

3.1        Only trained operator is responsible for weighing and dispensing of Raw Material. He/ She also maintains logbook.

3.2        Sr. Officer, Production/ Production Officer and QA Officer is responsible for monitoring of receiving and dispensing of raw materials.

3.3        Store In-Charge and Production In-Charge is responsible for proper execution of the SOP.

3.4        Head of Quality Assurance, Monitoring the system of compliance.

 

4.0      Abbreviations and Definitions

4.1        SOP - Standard Operating Procedure

4.2        FIFO – First In First Out

 

5.0       Materials and Equipment 

5.1  None         

 

6.0       Precaution / Health and Safety Considerations 

6.1        Ensure room condition (Temperature, Relative Humidity and cleanness) is OK according to the BMR.

6.2        Calibrate and check the function of the balance before start up dispensing and record the data in “Daily Balance Check Log Book”

6.3        Always keep the materials on pallet.

6.4        Use separate utensils for different raw materials.

6.5        Dispense the API after dispensing of all other excipients.

6.6        Ensure that the external surfaces of the containers are dust free.

6.7        Estimate the quantity spilled during dispensing and record in “Waste Disposal Logbook”

 

7.0    Procedure

7.1      Production department shall give material requisition sheet as per batch manufacturing record well in advance to stores department.

7.2      After getting material requisition sheet from production dept. store person shall check the availability of approved material as per respective batch.

7.3      If any material found is still lying in under test, the store person shall inform to Q.C. Immediately Store person shall transfer all the approved materials as per FIFO system at dispensing area.

7.4      Store person shall check and verify all the detail, Material name and code, approved label, Batch No. Mfg. Date and Retest date [use before date] before dispensing.

7.5      Store person shall check the dispensing area for its cleanliness, temperature and relative humidity of Dispensing Room before starting dispensing.

7.6      Remove all previous materials and documents from the Dispensing Room before receiving materials.

7.7      After getting Line clearance from QA department, store person shall put ‘On the RLAF of Dispensing Booth for 15 minutes before starting the dispensing activity.

7.8      After getting line clearance from QA person, take the materials to Dispensing booth and start the dispensing activity in presence of production person and store person.

7.9      Production person shall check the temperature and relative humidity and verify once again all the detail on the container.

7.10    If any discrepancy is found, it should bring to the notice of the Head of QA and necessary action is to be taken as per the instructions.

7.11    Place the container/ polythene bag on the balance in which materials to be taken. Then press the ‘TARE’ button to make tare zero.

7.12    Open the bulk container/ bag under Laminar Air Flow Hood and scoop the material into the empty container/ polythene bag.

7.13    Check the weight of each material against the BMR during weighing.

7.14    Write the factor (if any), actual quantity, and QC Ref. No. before dispensing each quantity of a material, then sign the BMR and Dispensing Logbook after dispensing.

7.15    If a material of more than one QC Ref. No (so more than one factor) dispensed, QA Officer will check it physically and sign in BMR during dispensing.

7.16    Seal the polythene bag having dispensed materials properly with cable tie and fixed dispensing label (Annexure-II).

7.17    Use separate clean utensils for each raw material.

7.18    After dispensing all materials take in container and fixed the label of “DISPENSED MATERIALS”. (Annexure-I)

7.19    Remove and tear off all the labels (‘APPROVED’, ‘SAMPLED’ etc.) of each empty container.

7.20    Store person shall clean scoops for each Excipients to avoid cross contamination and shall use separate scoop to avoid cross contamination.

7.21    Fix “TO BE CLEANED” label at all used equipment inside the room and Room.

7.22    Clean the area according to the respective SOP.

 

8.0      Reference Document

8.1       WHO GMP Guideline, trs-986, annex-2

8.2        In-house

  

9.0       Annexure 

9.1        Annexure-I         : Label of “DISPENSED MATERIALS”

9.2        Annexure-II         : "Dispensing Label”

  

10.0    Revision History

Version No.	Brief Reason for the Revision	Effective Date	Remarks
01.	New		-

 

 

 

11.0   Training 

11.1      Training is required for store officer, Production Officer and Quality Assurance Officer; trained by Head of Quality Assurance.

 

 

 

 

 

 

 

Annexure-I     : Label of “DISPENSED MATERIALS”

 

 

Name Address  DISPENSED MATERIALS   READY FOR PROCESSING  Product Name   Batch No   Batch Size   No. of item in this container   Container No.          __________________ Sr./ Production Officer (Signature and Date)      ________________________ Sr./ Quality Assurance Officer (Signature and Date)

 

Annexure-II         : "Dispensing Label”