1. OBJECTIVE
To lay down the procedure destruction of controlled sample (Raw Material and Finished Product)
2. SCOPE
This procedure is applicable to Quality assurance and Quality Control Department
3. RESPONSIBILITY
• Officer QA
• Manager QA
4. SAFETY INSTRUCTIONS
• All these activity shall be performed in the presence of QA supervisor.
5. PROCEDURE
5.1 Control sample will be taken for disposal one year after expiry as per the following procedure:
5.2 Blister & Strip packed tablets and capsules
5.2.1 The carton cover shall be depacked and content shall be defoiled and shall be collected in a double layer polybag.
5.2.2 The carton/insert box etc shall be destroyed by shredding.
5.2.3 The content (Tablet/ Capsule) shall be destroyed by dissolving in a container with water/crushing. These will then be poured in to the pit of ETP plant.
5.3 Bulk packed tablets and capsules
5.3.1 Empty the contents in a double polythene bag.
5.3.2 The content (Tablets/ capsules) shall be destroyed as given in point 5.2.3.
5.3.3 Bulk container shall be deshaped/ crushed and disposed in a drum/ container at the garbage area.
5.3.4 The labels shall be destroyed in the shredder.
5.4 Powder packed in laminated pouches or vials
5.4.1 Empty the contents in a container with water than this slurry shall be poured into the pit of ETP plant.
5.4.2 Pouches shall be destroyed by means of crushing in the shredder.
5.5 Liquid packed in vials, bottles or jars
5.5.1 Unseal the container and pour the content in water and then pour into the pit of ETP plant.
5.5.2 Store the empty containers in a drum. Remove the labels and destroyed all batch printed packing material by shredding.
5.6 Raw Material, Active Ingredients and Bulk Drug Substances
5.6.1 Empty the contents in a double polythene bag.
5.6.2 Empty the content in a container with water and then pour it in to the pit of ETP plant.
5.6.3 All the activity shall be performed in the presence of QA supervisor.
6. RELATED DOCUMENTS
Destruction of Controlled Samples Record – Annex. I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
8. ABBREVIATIONS
Q.A Quality Assurance Department
ETP Effluent Treatment Plant
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 10/08/2022 | 00 N/A | First Version |