Sop on Rejection and Destruction Policy of Drug Products and its Components

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3469

1.0 Objective

To establish the guidelines for destruction of drug products and its components.

Scope:

This sop shall be applicable for rejection, collecting, accounting & safe destruction of rejects, un-recoverable and expired pharmaceutical products and its components at various stage in pharmaceuticals company.

Responsibilities:

QA / production / warehouse / personnel & administration officer or above shall be responsible for rejection, destruction of rejected, unrecoverable and expired drug products & its components.

Accountability:

Head – QA shall be accountable for compliance of sop.

5.0 Abbreviations and Definitions:

SOP : Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.

QA    :     Quality Assurance

ETP  :     Effluent Treatment Plant

NAOH :   Sodium Hydroxide

QC         : Quality Control

6.0 Procedure:

6.1 Rejection and destruction of packing material:

6.1.1 Destruction of the printed packing materials from the shop floor:

6.1.1.1 Following printed packing materials shall be subjected for destruction on the shop floor.

i. Wrong or smudged overprinting labels, cartons, catch covers and show boxes which are rejected while over printing the batch details.

ii. Wrong or smudged overprinted labels, cartons, catch covers and show boxes that are rejected on packing line.

6.1.1.2 Procedure for the destruction of paper / card board type of printed packing material from shop floor.

i. The packing supervisor shall make entries in the register book as well as on the batch card for accounting the overprinting packing materials which shall be destroyed

ii. At the end of batch, the rejected printed packing materials shall be destroyed by shredding them off or subjecting to shredding machine, if available in the presence of a Q.A. Officer.

iii. The torn rejected printed packing material shall be transferred to the scrap yard.

iv. The personnel & administration officer shall ensure that these torn printed packing materials are taken outside the factory premises at suitable interval and are further destroyed by burning / shredding them at a safe place.

v. This operation shall be carried out after taking approval from Q.A.

6.2 Procedure for the destruction of printed, plain aluminum / pvc foils, rejected ropp caps, measuring cups, HDPE bottles, flip off seals glass bottles and vials from the shop floor:

6.3 Following packing materials shall be subjected for destruction on the shop floor.

i. Wrong or smudged overprinting foils which are rejected while over printing the batch details.

ii. De shaped or with other manufacturing and processing defects in ropp caps, measuring cups, HDPE bottles, flip off seals glass bottles and vials that are rejected on packing line.

6.3.1 The production officer shall make entries in BMR/BPR for accounting the rejeced packing material which are to be destroyed.

6.3.2 At the end of the batch, the shift production supervisor shall ensure that the printed aluminum and pvc for blister and strips shall be destroyed by cutting the roll into pieces or subjecting it to shredding machine, if available. Carry out this operation in the presence of a Q.A. Officer.

6.3.3 The cut foil shall be transferred to the scrap yard.

6.3.4 The line rejected ropp caps, measuring cups, HDPE bottles, flip off seals glass bottles and vials shall be destroyed by crushing / de-shaping them.

6.3.5 Apart from approvals from concerned production supervisor, it shall be the duty of the security officer / guards to ensure that no intact / filled bottles / vials are taken to the scrap yard.

6.4 Destruction of the printed packing materials from the warehouse

6.4.1 Any fresh material if rejected due to printer’s mistake than the printer shall do the sorting of packaging components. Sorted good and the rejected lots shall be destroyed.

6.4.2 If the material can not be salvaged and can not be reused, then it shall be destroyed by suitable destruction procedure.

6.4.3 The packing material stores supervisor shall ensure to take in writing from the supplier stating that the printed packing material shall be destroyed in his presence, along with the name of the product, type of packing material, quantity, date and the place where the printed packing material shall be destroyed.

6.4.4 In the event of introduction of new type of material, all the old type of printed packing materials shall be destroyed as above and recorded.

6.5 Procedure for destroying the printed packing materials from the warehouse:

6.5.1 If the printed packing material which is to be destroyed is a modvat item, then the packing materials warehouse supervisor shall intimate the finished goods warehouse supervisor for taking the permission for its destruction from the excise department.

6.5.2 Destroy the printed packing materials by subjecting it to shredding machine, if available. In case the shredding machine is not available then the packing materials destroy by manual cutting. Carry out this operation in presence of a security personnel and intimate qa department for verification.

6.5.3 If the printed material is destroyed by manual cutting, then after the distruction operation is over, recording of the above shall be done.

6.5.4 If large quantities of printed foils are rejected then these can be returned to the supplier, for the printed matter erasing under non-returnable gate pass.

6.6 Disposal of rejected raw materials from the warehouse:

6.6.1 Disposal of the rejected raw materials on party’s account shall be done if the raw-material is rejected by the quality control department. Then the party shall lift the material from quarantine.

6.6.2 Disposal of the rejected raw material on company’s account.

6.6.3 After taking approval as per annexure rejected raw materials, which are lying in raw material store, shall be lifted for disposal.

6.6.4 Upon receiving the approval for the disposal, proper documentation / records shall be maintained.

6.6.5 Before destroying the active material, de-activate them using 2% NAOH solution.

6.7 Destruction of expired / recalled/ rejected products from the finished goods warehouse:

6.8 Reasons of rejections of finish good.

  • Wrong overprinting of the batch details.
  • Fail in finish good testing by Q.C.
  • Recalled products in which corrective action and rework not possible.
  • Not released for dispatch and rejected by Q.A. head.

6.8.1 Before destroying the expired / rejected / recalled drug material from finished goods store, approval shall be taken from plant head and head – Q.A.

6.8.2 After receiving their approval, the finish goods are de-foiled / de-bottled / de-vials.

6.8.3 The de-foiled / de-bottled / de-vials drug products are then de-activated by treated with 2% NAOH solution.

6.8.4 The treated material is then drained into ETP. The record for the same is maintained.

6.8.5 Packing materials destroy as per procedure and transfer in scrap yard.

6.9 Destruction of non-recoverable material generated during manufacturing:

6.10 Reasons for non recoverable rejection.

  • Handling loss during manufacturing.
  • Material found out of specification for example lump formation.
  • Some kind of contamination or impurity observed.

6.10.1 The non-recoverable product (intermediate product) like; tablets, capsules, lubricated blend etc. Shall be destroyed after de-activating with 2% NAOH solution.

7.0 List of Annexure / Formats:

Authorization For Destruction – Annexure – I

8.0 References (if any):

  • SOP for collection and disposal of waste & rejected material from plant.
  • SOP on destruction and disposal of media filled vials
  • SOP for disposal of rejected primary and secondary packing materials.
  • SOP on withdrawal, storage, observation & destruction of control / retention sample.
  • SOP on inventory, storage issuing and destruction of rubber stereos
  • Sop on handling rejected raw materials.
  • Sop on rejected packaging material.
  • Sop for handling of scrap.

8.0 Distribution

8.1 Master copy –           Quality Assurance

8.2 Controlled copies- Quality Assurance, Personnel and Administration, Production-Oral and Ware house

9.0 History

     Date    Revision Number                       Reason for Revision
                       New SOP

 

Annexure – I

Authorization for Destruction

 

Product:                                              Batch no.:                        Batch size:

 

1.0 Details of the material to be destroyed:

 

Materials Make Quantity

 

2.0 Reason for destruction :

 

3.0 Cost involved :

 

4.0 Detailed investigation report :

 

Investigated by:

5.0 Method of destruction :

 

 

Proposed by                Approved by                    Authorized by

 

6.0 Destruction details :

 

Destroyed by

Checked by

Verified by

 

 

 

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