To lay down Procedure for Disposal of Expired or Obsolete Raw Materials.
This Standard Operating Procedure is applicable for disposal of expired or obsolete raw material (s) in pharmaceuticals formulation plant.
3.1 Executive / Head of store (RM) shall be responsible for implementation of the procedure.
3.2 Respective Heads of Quality Assurance, Quality Control, Pharma Research, Store (RM) and Materials Management shall be responsible for destruction of expired / obsolete material(s) (and if required, with requirements of other pharmacopoeias) in their area.
3.3 In case of Imported Raw Materials, Head Export will raise a request note to DRA for finalization of expired or obsolete material(s) after correspondence & authorization of destruction with the Drug Controller General (India) / Deputy Drug Controller or Drug Controller Authorities.
3.4 Director, operation & projects shall be responsible for authorization of destruction of expired / obsolete Raw Material(s).
4.0 Abbreviations and Definitions
RM : Raw Material
SOP : Standard Operating Procedure
Obsolete : The raw materials which are not intended to be used.
Expired : Products beyond shelf life
5.1 If any raw material is obsolete or expired, it shall be quarantined with distinct ‘OBSOLETE’ or ‘EXPIRED’ label by the Store Personnel and shifted to the designated rejected area or in banded store (if under excise).
5.2 In-charge / Head of store (RM) shall raise a note “Material(s) History Report” (Annexure-I), containing description of expired or obsolete material(s).
5.3 “Material(s) History Report” shall be sent to Heads QC, QA and Pharma Research and Export (if applicable), who shall first investigate the cause of expiry / obsolescence then conclude that the mode of the destruction of the expired / obsolete material(s).
5.4 During investigation this shall be evaluated (depending upon the category / nature of RM) that the expired / obsolete raw material(s) required destruction under any pharmacopoeial and / regulatory authorities any Act requirements and the decision shall be taken accordingly.
5.5 Head QA Shall give his final comments on Annexure-I.
5.6 After getting filled and approved annexure-I, by QA Head, details of material(s) for destructions shall be filled in the destruction note (Annexure-2) by Officer / Executive Store (RM).
5.7 Final approval for destruction shall be given by unit Head Operation.
5.8 Head (RM), shall decide the destruction date and shall intimate all concerned Department Heads about the destruction date.
5.9 Proper entries shall be made in raw materials stock register (Annexure-3) by In-charge / Officer RM Store and information shall be sent to excise department to get the entries done in their respective record for the material(s) to be destroyed.
5.10 After counter checking the materials shall be destroyed in the presence of In-charge / Head, Store, QA, QC and counter signed in Annexure-II.
5.11 Method of Destruction
5.11.1 All the expired / obsolete raw materials whether liquid or solid shall be destroyed as the mentioned procedure.
22.214.171.124 Obsolete / expired raw material shall be first dissolved or prepared a slurry in potable water.
126.96.36.199 Destruction shall be done through ETP/ Incinerator.
5.12 The entire packaging component, where the material comes directly in contact with the active pharmaceutical ingredient or excipients shall be sent to scrap yard for further disposal.
Numbering Procedure for destruction
5.13 After completion of investigation and destruction, both “Material History Note” and “Destruction Note” shall be assigned an identical number by officer / executive QA, duly signed and retained in QA department. Both annexure’s shall have identical nine digit number the form EXP XXX/YY or OBS XXX/YY respectively.
EXP – Stands for expired Raw Material
OBS – Denotes obsolete Raw Material
XXX – Serial no. of the Raw Material
YY -Last two digits of the year. i.e. 16 for 2016, 17 for 2017, etc. A new series of note shall be initiated every new year. e.g. A separate series shall be maintained for expired and obsolete raw material. The first report of Destruction for expired material of the year 2016 shall be numbered as EXP001/16 while second report of destruction for obsolete material of the year 2016 shall be numbered as OBS 002/16.
5.14 A copy of both i.e. “Material History Report” and “Destruction Note” shall be issued by Head-QA for Head stores for there reference.
6.0 Forms and records
6.1 Material(s) History Report – Annexure-I
6.2 Destruction Note – Annexure-II
6.3 Raw Material Stock Register – Annexure-III
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copies – Store, Quality Control, Quality Assurance, Head Export, Material Managements, R&D (Doc Cell), RA, Production.
|Date||Revision Number||Reason for Revision|
MATERIAL(S) HISTORY REPORT
Material Name :
Item Code :
Supplier Name :
Qty Received & Date :
Qty expired / obsolete :
Qty. in Stock :
Cause of expiry / obsolescence :
Value of Material expired / obsolete :
Expired / obsolete A.R. No. :
Invoice No. & Date :
Mode of Destruction :
Pharmaceopoeial / Act / regulatory requirement
(EXPIRED OR OBSOLETE RAW MATERIALS)
MND No. & Date : _______________________ Division : ________________
Material Name : _______________________ Item Code : ________________
Supplier Name : _______________________ Invoice No. & Date : ________________
Qty Received & Date : _______________________ A.R. No. : ________________
Qty. in Stock : _______________________ Obsolete Qty. : ________________
Value of Obsolete Material : _______________________
Reason of Obsoletion : _________________________________________________________________
The above material is not suitable for use, therefore to be destroyed.
Prepared by Verified by Approved by
(Officer / Executive Stores) (Manager : Head, RM Store) (Head – Operations)
Proposed date of destruction of material: _______________ Head Stores ___________
(To be filled by Head Stores) (Sign/date)
Material destroyed on ___________________________________ in the presence of :
QUALITY CONTROL: _______________________ (Sign/date)
Store: _______________________ (Sign/date)
Security: _______________________ (Sign/date)
Quality Assurance: _______________________ (Sign/date)
Head Head, Head Head
Quality Control Export (If Applicable) Pharma Research, Quality Assurance