This document details the procedure for collection, storage, and withdrawal of Retained/ Reference samples. It is the policy of Xyz Limited that written procedures shall be followed for the collection, storage, and withdrawal of retained/reference samples to ensure that sufficient quantities of retained / reference samples are collected that will allow a sample for analytical testing and to provide a specimen of the fully finished product.
This document shall be applicable when retained /
reference samples are taken and stored within XYZ. Also to be used as a point
of reference for future ongoing use.
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3.0 RESPONSIBILITY AND ACCOUNTABILITY
Persons along with their responsibilities are given below:
Executive - Corporate Quality Assurance: - To prepare and follow the SOP accordingly. Maintain the records as per SOP.
Manager -Quality Assurance: - To ensure implementation of SOP
4.0 PROCEDURE
5.1 FOR PRODUCTION
5.1.1 FINISH PRODUCT COLLECTION and STORAGE
5.1.1.1 Collect the blisters/strips/bottles equivalent to or a minimum of 100 tablets (depending on pack size) for retained/reference samples.
4.1.1.2 The label for the retained sample shall be used as
per SOP for the “Labeling policy” label for “Control Sample”.
4.1.1.3 Affix this label at a suitable place on cartons
/bottles containing retained/reference samples.
4.1.1.4 The production unit will maintain the retained and
reference sample storage record as per APPENDIX SOP “Finished
Product retained/reference sample record” and the commercial
laboratory/ analytical division will fill the retained/reference sample record
as per ANNEXURE “Retained / Reference Sample Record”.
4.1.1.5 Retained/reference samples from each batch of the
finished product should be retained for at least one year after the date of
expiry.
4.1.1.6 If there is any in-house and/or regulatory-related
investigation pending, in such cases, retained / reference sample shall be
retained till completion of investigations.
4.1.2 STARTING MATERIAL COLLECTION AND STORAGE
4.1.2.1 Collect retained/ reference samples of the
starting materials (other than solvents or water used in the manufacturing
process).
4.1.2.2 Ensure that the quantity of retained/ reference
samples must be sufficient for at least two complete analyses for all starting
materials.
4.1.2.3 Ensure that the quantity of retained/ reference
sample must be sufficient for at least two complete analyses for all starting
materials of NAPP Product.
4.1.2.4 The label for the retained sample (starting
material) shall be used as per SOP for “Labeling policy” “Control Sample”.
5.1.2.5 Affix this label on the retained/ reference sample
container place the sample on an identified shelf and record the location
with appropriate detail in an SOP. Starting Material retained/ reference Sample
Record.
4.1.2.5 Samples of starting materials of each batch
should be retained for at least five years from the date of receipt.
4.1.2.6 If there is any in-house and/or regulatory-related investigation pending, in such cases, retained / reference sample
shall be retained till completion of investigations.
4.1.3 PACKING MATERIAL COLLECTION AND STORAGE
4.1.3.1 Collect retained/ reference samples of primary and
printed packing materials.
4.1.3.2 Ensure that the quantity of retained/ reference
samples must be sufficient for at least two complete analyses for all packing
material.
4.1.3.3 Component of packing materials shall be packed
in a self-sealing poly bag.
4.1.3.4 The label for the retained sample shall be used
as per SOP for the “Labeling policy” Label for “Control Sample”.
5.1.3.5 Affix this label on the retained/ reference sample
container (self-sealing polybag) and place it in a shipper/container in the
retained sample room.
5.1.3.6 Record the storage and disposal of packing
material components as per SOP Packing Material retained/ reference Sample
Record.
5.1.3.7 Retained/ reference sample of packing material
shall be retained for at least five years from the date of receipt.
4.1.3.8 If there is any in-house and/or regulatory-related investigation pending, in such cases, the reference sample shall be
retained till the completion of investigations
5.2 FOR ANALYTICAL DIVISION
5.2.1 All the samples received for testing shall be coded
and then half of the sample shall be given for analysis and another half of
the sample shall be kept as a retained/ reference sample.
5.2.2 All the control samples shall be labeled as “CONTROL
SAMPLE” (Label SOP refer SOP for “Labeling policy” i.e. SOP) and stored in the
control sample storage room.
5.2.3
Retained samples shall be kept in the storage at 25oC ± 2 oC
and relative humidity should not be more than 55%. If there is any specific
requirement for raw material as recommended by the manufacturer, the material
shall be stored as per the recommendations.
5.2.4 In Case of any investigation retained/reference sample
shall be provided after the approval of the Quality Assurance Manager and
Person In Charge. The same shall be recorded as per the ANNEXURE “Retained/reference
sample record”.
5.2.5 Retained samples shall be withdrawn as per ANNEXURE
“Retained/reference sample withdrawal record.
5.2.6 Destruction of retained/reference samples shall be done
as per SOP for the destruction of retained/ reference samples.
5.3 PERIODICAL VISUAL INSPECTION OF THE finished product
5.3.1 Carry out periodic visual inspection of all finished
products, every six months from the date of manufacturing, up to the
required storage period of the respective product
5.3.2 Carry out a visual inspection of the
retained/reference sample for the integrity of containers, labels,
adhesion of labels on containers, blisters, or any evidence of deterioration.
5.3.3 After visual inspection, ensure that the sample is
kept at its designated place.
5.3.4 Record the observation of visual inspection on the SOP
Periodic Visual Inspection Record.
5.3.5 If any evidence of deterioration is observed then
immediately inform to QA Manager and investigate it as per SOP out of
Specification Results.
5.4 RETAINED / REFERENCE SAMPLE STORAGE CONDITION
5.4.1 Store the finished products /starting material
under temperature NMT 25°C and RH NMT 55%.
5.4.2 If there is any specific requirement for raw
material as recommended by the manufacturer, the material shall be stored as
per the recommendations.
5.5 RETAINED/ REFERENCE SAMPLE WITHDRAWAL
5.5.1 Whenever any material is required to withdraw for a production unit, a record of withdrawn quantity with reason shall be maintained as per SOP retained/ reference sample withdrawal record (Appendix V) and reported to the head of the department. The commercial laboratory/analytical division shall fill the above-mentioned record as per ANNEXURE Retained/ Reference Sample Withdrawal Record.
>SOP for Standard testing procedures in the pharmaceutical industry