SOP for Destruction of Placebo Batches
Objective : To lay down a procedure for Destruction of Placebo Batches (Analytical/Clinical).
Scope : This Standard Operating Procedure is applicable for formulation plant.
Responsibility :
Executive/ Manager – Production shall plan the destruction of Placebo batches after consultation with Quality control, PDL, R&D ,Stores and Quality Assurance.
Head- Stores/ Production/QC/QA shall approve the destruction note before final authorization.
Head-Clinical Research Department shall approve the destruction note for destruction of Clinical Placebo batches.
Head-R&D shall approve the destruction note for destruction of Analytical placebo batches.
Director (Operation & Projects) – Final Authorization for destruction of placebo batches.
Head – QA/Production or his/her designee shall be responsible for implementation and compliance of this SOP.
Abbreviations and Definitions
PDL – Product Development Laboratory
MDN – Material Destruction Note
Placebo Batches – Placebo batches are manufactured in order to validate the critical test parameters and the environmental conditions through stability studies.
R&D -Research and Development
CRD – Clinical Research Department
Procedure
After consultation from R&D, QC, PDL, Stores and QA, the production executive / manager shall plan for the destruction of placebo batches (Analytical / Clinical).
Production personnel shall raise the MDN for the destruction of placebo batch.
Officer / Executive production and QA shall ensure the reconciliation and completion of Placebo BMR before destruction of Placebo batches.
Destruction Note for Placebo shall be prepared product wise with details of Batch Nos to be destroyed
Executive / Manager Production shall verify the quantity of the Placebo batches (Analytical / Clinical) and record the same in “Destruction Note for Placebo” as per Annexure-1. Labeling of the material meant for destruction shall be done as per SOP titled “Scrap Management and Disposal”.
Executive / Manager Production shall mention the reason for the destruction of the material and shall send the destruction note to the concerned departments for their approval.
Officer/ Executive QA shall send the Destruction note to R & D and Clinical Research department for approval.
Finally, Head QA shall approve the destruction note after getting the assessment form all the concerned departments and shall forward the same to Director (Operations and Projects) for final Authorization.
Destruction of Placebo batches (Analytical/Clinical) shall be done only after getting the final authorization from Director (Operations & Projects).
Executive/Manager Production shall intimate the concerned departments as mentioned for the destruction date for the placebo batches (Analytical/Clinical) as mentioned in the destruction note.
The material shall be destroyed as per the respective destruction SOP.
Note: The material meant for destruction shall be stored separately and shall be labeled as per SOP”.
After counter checking the quantity the material shall be destroyed in presence of Store, Quality Assurance and Security personnel.
After destruction all the authorized personnel or his/her designee shall sign the destruction note.
‘Destruction Note for Placebo’ shall be numbered in ten characters as described below:
The first character shall be first alphabet of the location of the formulation plants(s)/ operations e.g. ‘B’ shall represents Baddi.
The Second, Third and fourth character shall be ‘MDN’ which represent the ‘Material Destruction Note’.
The fifth, sixth and seventh character are numbers, which shall denote serial number of the destruction note for placebo. The first requisition number shall be 001. The subsequent serial numbers shall be 002, 003 and so on.
The eight characters shall be ‘/” (Slash).
The ninth and tenth character shall represent the financial year e.g. 25 for April 2025 to March 2026 and 26 for April 2026 to March 2027 likewise.