Retention Sample, Purpose:
Retention Sample, To establish general guidelines for sampling, handling and storage of Retention sample of finished products for regulatory testing and for resolution of customer complaints.
Retention Sample, Scope:
This procedure is applicable for both General block and Sterile block at XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]BPR: Batch Packaging Record
[][]QA: Quality Assurance
[][]QA: Quality Assurance
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To ensure proper handling & storage of retention sample following this SOP.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
[][]At the start of packaging operation, retention sample of every batch for different dosage form shall be taken by the Quality Assurance personnel engaged in In-process checking as follows-
[][]Tablet: Not less than 60 Tablets (Equivalent to unit packs)
[][]Capsule: Not less than 60 Capsules (Equivalent to unit packs)
[][]Powder for Suspension: Pack size is 35ml or less- 6 unit packs & Pack size is above 35 ml- 4 unit packs
[][]Kidney Dialysis Fluid: 1 Pack (10 L)
[][]Liquid Sterile: Not less than 60 ml (Equivalent to unit ampoule or pack)
[][]Sterile Powder for Injection: Not less than 10 unit packs
[][]Retention samples of finished product shall be collected from each part (i.e., each type of pack -commercial, trial aid, export, institutional, etc.) of a batch. During collection of retention sample followings shall be considered –
[][]Full retention sample shall be collected from first time packaging whether it is commercial or export.
=>One or two unit packs shall be collected from next each part.
=>Representative samples shall be collected from any pack of export or trial aid pack.
[][]Quantity of the retention sample shall be recorded and signed with date on Batch Packaging Record by the concerned Quality Assurance executive.
[][]Quantity of the retention sample shall be recorded and signed with date on Batch Packaging Record by the concerned Quality Assurance executive.
[][]The samples shall be sent to retention sample store after keeping record into the “Annexure-I: Retention Sample Archiving Log Book” of specific Quality Assurance station.
[][]Before archiving the retention sample in the specific rack, entry shall be given for Product name, quantity, Batch No., Mfg. Date and Exp. Date. At the same time, Serial No. shall be given on the outer side of the carton/pack of retention sample for easy identification.
[][]Serial number of retention sample shall be given as follows-
GR/XX/YYY
Where,
=>“GR” stands for General Retention (For Sterile Block it will be CR)
=>“XX” stands for the last two digit of the year. It will be changed for next year.
=>For example- AA for year 20AA, BB for 20BB and so on.
=>“YYY” is the sequential number. In every new year it will be started from 001 and so on.
[][]Retention sample of each batch shall be kept up to the product shelf life plus one year (minimum).
[][]The Retention samples shall be stored under ambient temperature of the retention sample store (Temperature should be NMT 30ºC). For sterile powder for Injection products this room temperature will be controlled as not more than 25º C.
[][]Temperature of Retention sample store shall be recorded in “Annexure-II: Temperature Record Sheet” regularly (at least two times in a day i.e. at 9:00 AM and 4:00 PM) using calibrated thermo hygrometer. At the same time maximum and minimum temperature shall be recorded at 8:30 AM in each day.
[][]Requisition for Retention sample shall be raised through Annexure-III: Requisition Form for Retention Sample. Samples/Documents shall be provided to requester dept. after getting approval of Head of Quality Assurance. No of supplied retention samples to be recorded in the retention sample register.
[][]After the stipulated storage time (Shelf life plus one year), all the retention samples will be discarded through the SOP of “Procedure for disposal of material and products”, SOP.
Annexure:
Annexure-I: Retention Sample Archiving Log Book
Annexure-II: Temperature Record Sheet
Annexure-III: Requisition Form for Retention Sample