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Reconciliation of Packing Materials and Bulk-SOP

Standard Operating Procedure (SOP) for reconciliation of packing materials and bulk at the end of the packing of each batch of Drug Product

SOP for Reconciliation of Packing Materials

1.0   PURPOSE:

    • The purpose of this Standard Operating Procedure (SOP) is to describe the detailed procedure for the reconciliation of packing materials and bulk at the end of the packing of each batch.

2.0   SCOPE – SOP for Reconciliation of Packing Materials:

    • This procedure is applicable for reconciliation to all the different types of packing materials and bulk used during packing activity.
      • StripsReconciliation of Packing Materials
      • Blisters
      • Sachets
      • Bottles
      • Tablets
      • Capsules
      • Powder

3.0   REFERENCES – SOP for Reconciliation of Packing Materials:

    • In House
    • Clearance of Lines, Area, and equipment. <SOP>
    • IPQC during packaging Operation. <SOP>
    • Handling and Usage of residual Recovery. <SOP>
    • Handling and destruction of Non- recoverable Recovery. <SOP>
    • Destruction of waste generated during packing operation. <SOP>
    • Cleaning and Operation procedure for online carton coding <SOP>     
    • Return of Leftover packing material <SOP>

4.0   RESPONSIBILITY – SOP for Reconciliation of Packing Materials:

    • The production person shall be responsible for-

    • Checking the packing materials item codes, its quantity, and bulk against MRO, BMR and BPR during the start of the operation.
    • Handling the rejection generated in different stages of packing operation as per standard instruction and its documentation.
    • Receiving excess packing materials and return excess packing materials to the stores and document the same.
    • Reconciling the packing materials at the end of the packing.

    • The quality assurance shall be responsible for

    • Check and verify the packing materials item codes, its quantity, and bulk against MRO BMR and BPR.
    • Verify the rejection quantity is documented in the respective documents.
    • Counter checking receipt of excess packing materials and return excess packing materials to the stores and document the same.
    • Verify the reconciliation of packing materials at the end of the batch.
    • Quality Head and Plant Head shall be responsible for review and approve the SOP.

5.0   PROCEDURE – SOP for Reconciliation of Packing Materials :

    • Reconciliation of primary packing materials( Aluminium Foil / PVC / PVDC / Bottle / Caps / spoon ):

    • The reconciliation of primary packing materials details shall be recorded as mentioned below:

Sr. No.

 Reconciliation of Packing Materials details Printed foil Plain Foil/PVC/PVDC ( Kg) Bottle (Nos.) Cap (Nos.)

Spoon (Nos.)
A. Standard Consumption for 1.0L Tablets/capsules/sachets/Bottles (A)
B. Quantity issued from PMS(B)
C. Quantity issued as additional/online Rejection(C)
D. Total quantity issued

(D) = (B + C)                   
E. Samples(E)

(Tablets/ capsules/ sachets)
F. Quantity packed  (F)

(Tablets/ capsules/ sachets /Bottles)
G. Quantity returned to PMS(G)
H. Actual consumption

(H)= (D –G)
I. Std. consumption for Packed Qty. (I)= { A x (E + F)}/100000
J. Rejection (J)= ( H – I)
K. Rejection (%)(K) = J x 100/I

    • The above reconciliation details shall be made part of each BPR.

    • Calculate the packing material per 1 lac. Tablets/ capsules/sachets/ bottles by using standard quantity mentioned in MRO.
    • Write the standard quantity of packing materials for per 1 lac Tablets/ capsules/sachets/ bottles and enter the same in ’A’.
    • Write the issued qty. by PMS in the respective columns against’ B’.
    • During operation, if any additional primary packing material is required/ online rejection replacement quantity is required, get issued from PMS and enter the quantity in the respective column against ‘C’.
    • The total qty. issued for packing is calculated by adding (B +C) and entered the same in ‘D’.
    • Enter the qty. of primary packing material return to the stores in the respective column in’ G’.
    • Calculate the total consumption of primary packing material (D- G) and enter the same in ‘H’.
    • Enter no. of Tablets/ capsules/sachets/bottles sampled by QA in ‘E’.
    • Enter no. of Tablets/ capsules/sachets/bottles packed in ‘F’.
    • Calculate the total quantity of primary packing material used for packing total quantity (E+F) by calculating with the formula given in ‘I’ and enter the quantity the same in ‘I’.
    • Rejected primary packing material is calculated as ( H–I). and enter the quantity in ‘J’.
    • The percentage of rejection is calculated using the formula given in ‘K’. and quantity is written in ‘K’.

    • Reconciliation of Secondary and tertiary packing materials:

    • The reconciliation of secondary and tertiary packing material details shall be recorded as mentioned below:
Sr.

No.

 Reconciliation details Applicator (Nos) Sticker label (Nos.) Show Box (Nos.) Inset (Nos.) Inner Shipper (Nos.) Outer Shipper (Nos.) Shipper Labels (Nos.)
A. Quantity Issued from (A)
B. Quantity issued as additional / online Rejection(B)
C. Total  quantity Issued = (A+B)
D. Quantity packed (D)
E. Quantity returned to PMS(E)
F. Samples attached to BPR (F)
G. QC samples (G)
H. Quantity rejected (H) (Overprinting / other than overprinting / unused / excess)
I. Total qty. packed              (I) = ( D+F+G+H)
J. Rejection (%)(J) = (H x 100/I)
    • Above reconciliation of packing materials, details shall be made part of each BPR.
    • Write the issued qty. by PMS in the respective columns against’ A’.
    • During operation, if any additional primary packing material is required/ online rejection replacement quantity is required, get issued from PMS and enter the quantity in the respective column against ‘B’.
    • The total qty. issued for packing is calculated by adding (A +B) and entered the same in ‘C’.
    • Enter the qty. of packing material return to the stores in the respective column in’ E’.
    • Enter no. of quantity attached to BRP as reference samples in ’F’.
    • Make entry no. of quantity sampled by QA/QC in ‘G’.
    • Enter quantity packed in ‘D’.
    • Enter quantity rejected in ‘H’.
    • Calculate the total quantity of packing material used for packing total quantity (D+F+G+H) and enter in ‘I’.
    • The percentage of rejection is calculated using the formula given in ‘J’. and quantity is written in ‘J’.

Note: –  (SOP for Reconciliation of Packing Materials)

    • All the used labels which are not suitable for labeling purpose shall be stored till the completion of the packing activity.
    • At the end of the batch, all such rejected labels shall be counted and reconciliation shall be performed against the issued quantity.
    • After satisfactory verification of label rejection and label reconciliation, rejected labels shall be destroyed in presence of QA and details shall be recorded in the respective BPR.
    • The rejected quantity should match the difference of issued quantity and used quantity.
    • In case of any discrepancy observed during reconciliation shall be informed to packing in charge and QA for further course of action.
    • If the total consumption for
      • Blister primary packing material is more than10%
      • Strip primary packing material is more than 10%
      • Pouch and bottle pack primary packing material is more than 10%
    • Then investigate the same and file event/ temporary change control for the same.

  • Reconciliation of Tablets/ capsules/powder:

    • The reconciliation of Tablets/capsules/powder details shall be recorded as mentioned below:

Sr. No.

 Description Actual Units
A. Standard Batch size (A) Nos.
B. Quantity received for packing (B) Nos.
C. Total quantity transferred to BSR ( Sale Pack) (C) Nos.
D. Total quantity transferred to BSR(PS) (D) Nos.
E. Total quantity transferred to BSR(Bulk Pack) (E) Nos.
F. Total quantity transferred to BSR(Others) (F) Nos.
G. Control sample/ stability/PV/Hold time/Micro Sample (G) Nos.
H. Balance quantity ( Tablets/capsules) for packing (H) Nos.
I. Total quantity packed (I) = ( C+D+E+F+G+H) Nos.
J. Accountability(J) =                                                                            

(total qty. packed+ Recovery( Packing) + Non recovery (Packing)) X 100

 Quantity received for packing

 %
K. Total recovery (K) Nos.
*L. Total Non-recovery (L) Nos.
M. Final batch yield (M)  =        Total qty. packed x 100

 ( Without Recovery)            Standard batch size (A)

 %
N. Final batch yield(N)  = (Total qty. packed +Total recovery) x 100

 ( With Recovery)                 Standard batch size (A)

    %

  • The above reconciliation details shall be made part of each BPR.

    • Enter the standard batch size in ’A’.
    • Enter quantity received from manufacturing to packing in’B’
    • Make entry the quantity transferred to BSR (Sale pack) in ‘C’.
    • Enter quantity transferred to BSR (P.S.) in ‘D’.
    • Enter quantity transferred to BSR (Bulk Pack) in ‘E’.
    • Make entry the quantity transferred to BSR ( for other packs) in ‘F’
    • Control samples and other samples are entered in ’G’.
    • The balance quantity of tablets/ capsules kept aside is entered in ‘H’.
    • Total qty. packed are calculated by formula mentioned in ’I’ and enter the quantity in ‘I’.
    • Calculate the total accountability as the formula mentioned in ‘J’ and enter the value in ‘J’.
    • The recovery generated is entered in ’K’.
    • Total non-recovery is entered in ‘L’.
    • Final batch yield (without recovery) and (With recovery) is calculated as per the formula mentioned in ‘M’ and ‘N’ respectively and enter the same in the respective row.

Note: – If the batch packing yield is less than the specified limit, then investigation the same and file event/ temporary change control for the same.

6.0   Annexures :

    • NA
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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]