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1. Purpose
The purpose of this SOP is to provide a guideline about the disposal procedure of expired quality records of (Company Name), Bhaluka.
2. Scope
This SOP is applicable for all expired quality records of (Company Name).
3. Responsibilities
3.1 SVP, Factory Operation is responsible to give authorization for destruction of expired quality documents.
3.2 VP, Quality Operation is responsible to give the approval for destruction of expired quality documents.
3.3 Head of Quality Compliance is responsible to ensure that each and every expired documents are listed that prepared by his/her designate nominee.
3.4 Designate nominee of Head of Quality Compliance is responsible to prepare a list of expired archived documents.
3.5 Head of respective department is responsible to assign a person to supervise the destroying activities.
3.6 In charge, Administration is responsible to assign a person to monitor the destroying activities.
4. System Description
Not Applicable.
5. Precautions
Ensure that no current versions of documents are mix up with expired documents.
6. Definition
Expired Documents: Expiration is the time in which an archived document reaches the end of its retention period. These documents may include commercial product batch documents, Obsolete SOPs, Obsolete BMR, BCR, BPR documents, PM documents, RM documents, FP documents etc.
7. Procedure
7.1 Designate nominee of Head of Quality Compliance should prepare a list of expired documents that should destroy.
7.2 Consider documents for destroy according to following time limit.
| Commercial batch documents | After 05 years from the date of expiry |
| Retention Sample Documents | After 03 years from the date of expiry |
| Obsolete BMR,BCR & BPR | After 01 year from the date of obsolete |
| Obsolete SOP | After 06 years from the date of expiry |
| RM (Both active & Excipients) Documents | After 05 years from the date of expiry |
| FP Documents | After 06 years from the date of expiry |
| PM Documents | After 05 years from the date of expiry |
7.3 Designate nominee of Head of Quality Compliance should Store disposal listed expired documents in a place inside the archive room & properly labeled & store under lock and key until disposal.
7.4 Should record in a register with the following information.
Name of documents
Quantity and batch number (if applicable)
Date of expiry
Date of destroy
Remarks
7.5 Expired quality records must be destroyed within the factory.
7.6 Destroyed expired quality records within Seven days after the approval for disposal.
7.7 Should Rip or burn (if applicable) the expired documents in presence of persons from following Departments.
Quality Compliance
Respective department
Administration or Security
7.8 Should take signature of the attendee.
