OBJECTIVE
To lay down a procedure for handling, storage, retrieval, and disposition of retention samples of drug Products
SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.
RESPONSIBILITY
Execution: Chemist and above – QC department.
Checking: Asst. Manager and above – QC department
PROCEDURE
- Control samples are collected at random during the packaging operation of every batch of each product.
- The number of samples collected shall be entered in the register Annexure - 01.
- Control Samples shall be kept in the Control Sample Room with appropriate arrangement for maintaining temperature
- Environmental conditions for Temperature shall be monitored and recorded twice a day as per the format detailed in Annexure - 02.
- Retrieval of control Samples.
- A request shall be raised indicating the reason and quantity and forwarded to the Head-QA or his designee for withdrawal of any control sample (for investigation and reviews) in the format as detailed in Annexure - 03.
- Serial no shall be given to each request as per FP/XXXX/YY. Where, FP – Finished Product, XXXX – Serial No starting from 0001, YY- Current Year
- The request shall be justified by mentioning the reason for the removal of the control sample.
- Only upon approval of the request by the Head-QA or designee, the control samples shall be retrieved.
- Destruction of Expired Finished Product Control Samples.
- Control samples shall be maintained for at least one year after the expiration date of the drug product.
- QC chemist shall prepare a list of expired control samples of finished products due for destruction after every six months i.e. twice a year as per Annexure - 04.
- Destruction of the control sample shall be done as per the current version of SOP.
ABBREVIATION
SOP : Standard Operating Procedure
Q.C : Quality control
℃ : Degree centigrade
ANNEXURE
Annexure No. - 01: Control Sample Record Register
Annexure No. - 02: Log for Environmental condition monitoring of control sample storage area.
Annexure No. - 03: Control sample issuance request
Annexure No. - 04: List of expired control samples of finished products due for destruction
REVISION HISTORY
Nil
0 Comments