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SOP for Handling and Storage of Control Samples


OBJECTIVE
To lay down a procedure for handling, storage, retrieval and disposition of control 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.
  1. A request shall be raised indicating the reason and quantity and forwarded to Head-QA or his designee for withdrawal of any control sample (for investigation and reviews) in the format as detailed in Annexure - 03.
  2. 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
  3. Request shall be justified mentioning the reason for removal of the control sample.
  4. Only upon approval of the request by Head-QA or designee, the control samples shall be retrieved.
  • Destruction of Expired Finished Product Control Samples.
  1. Control samples shall be maintained for at least one year after the expiration date of the drug product.
  2. QC chemist shall prepare a list of expired control samples of finished products due for destruction after every six months i.e. twice in a year as per Annexure - 04.
  3. Destruction of the control sample shall be done as per current version of SOP.
ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.C : Quality control
oC : Degree centigrade

ANNEXURE(s)
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

Click an Image below is provided (as is) to download Annexure

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REVISION CARD
Nil


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