Ware House For Raw Materials

Ware House procedures for Raw materials

Content:          

a)  Handling  of  Incoming raw materials.

b)  Sampling and Quality Control Procedure. 
c)  Storage of raw materials

a)      Handling of Incoming Raw materials.  

Receiption: 

1. On arrival of raw materials  the Ware House  officer checks the name and quantity  against  a copy of Purchase order.
2. The Ware House officer checks the materials against the Invoice  as well as purchase order
2.  After receipt, a copy of the receipted invoice is sent to the Procurement  Dept.
4. Weight of all in coming materials is checked and then placed in a separate sealed off Quarantine area batch wise / Lot wise with a  "Under Test" yellow Label No QA/ Form/009 showing QA code no, SL no, date, month, year, signed by QA officer with date.
5. If the cartons / boxes / drums etc are opened special care has to be taken to make them free of dirt and foreign materials.
6. The arrived raw materials are entered in the materials receive book. The receive book records the following  : 

-       room no

-      date

-      materials home

-      L /c no

-      Invoice no

-     M . R . No

-     Lot / Batch No.

-     Mfg.  date

-     Exp.  date

                       ­ -     Invoice /chalan Quantity

-     Received Quantity, Total Quantity & pack size x NO of Container (s)

                        -     Short/ Excess

                        -     Remarks

b)      Sampling and Quality Assurance

1.    The ware house keeper submits a Material Receiving  Note form No W H/  form/003 to 

      QA Deptt. Material Receiving  Note form  records the requisite  information.

2.    The Q.A Deptt.  Sends a sampler to the ware house . The Q A sampler checks the raw

       materials and  takes appropriate sample as per approved  sampling method. Then the 

       lot/ batch consists of 1 to 5 containers, equal  amount of sample are taken from each

       container  under sampling procedure  ( S O P )  and are pooled for analysis . For lots

       with a large number of drums / bags  /containers the samples are taken from 5 

       drums / bags/ containers or  from ÖN+1 drums /bags/ containers which ever is larger

       and pooled for analysis. Samples so taken from drums / bags /and   containers duly 

       labeled with a white label  no QA /Form / 017.

      
If  sample is taken by making hole in the sacks, the holes are covered  with the above label.

3.   Analysis are performed in accordance with the requirement of :

-    Laid down specification

            -    B P

                        -    U S P   &

                        -     pharmacopoeia that recognized

4.  The results of analysis  are recorded in the "working Sheet for Raw material "Form No QA/Form/ 019. Raw data   are kept on the reverse side of form  & also in the analyst's  book.

5.  A ref. No in put on the working Sheet for raw material (Form No/QA /Form /019) and duly signed by QC manager, Ref No is made up of material code No, chronological  No of the consignment and year

6.   On the basis of the result material Receiving Note (Form NO W H   Form/ 003 ) is duly filled in by QA Deptt.  along  with the form.

- if passed Form QA /Form/002

- if Rejected QA/Form/ 015

- if required urgently QA /Form/011

- if the material non conforming QA/Form/ 007

7.    Material Receiving Note is so received is retained  by the store officer for documentation and QA arranges labeling by affixing passed label Form no QA/ Form/02 on the body of drum & not on the lid & at the same time under test label is pulled out or removed.

8.   Assay/ purity in percentage  is written in the space provided for

9.  If exigency, a raw material is needed & to be used in production before it has been approved by QA Deptt, the store officer marks "urgent" on the Form "material Receiving Note" The material can only be delivered to the product. Deptt. when QA releases the material vide Form No QA/ Form/011.

10. When a material is rejected  QA sends the M R Note with rejection comment to the store officer. QA Deptt. affixes the Rejected label No QA /Form/015 (version no 2 ) to each container. Part release/ /reject is followed  on  above procedure.

11. Q. C Deptt. Retains sufficient sample of each approved materials for 3 years to be able to per- form three complete analysis.  

         

C. Storage of Raw materials 

1. Approved raw Materials are released from quarantine and stored in special permanent location. 
2.  The  room is divided into three large sections : 
     - Active materials 
     - Excipients
   - Flavourings essences, food colors, & other active materials which are most temperature    sensitive Narcotics are stored in a separate sealed off area. Cold chain materials are stored in the refrigerator.  Heat sensitive Raw materials / chemicals are stored in air conditioned area . Hygroscopic  materials are stored in air conditioned area in sealed conditioned .The raw materials are stored in conditions designed to protect from deterioration and pollution. 

3.  A bin card (stock card ) form no W H /Form/oo4 is maintained for each materials  for immediate Inventory . Production manager is daily  informed of the stock by the store official . 

4.  Raw materials which have been stored for six months or more are  examined as per SOP before use. 
5. Rejected raw materials are stored in a special area designed for their purpose until they are sent back to the supplier or damaged as desired by the supplier.