The control sample is a portion of a finished product or raw material’s specific lot or the packing material’s few units, preserved in a control area for future analysis and reproducing purposes. Retention of the control sample is a part of the huge documentation process practiced in the pharmaceutical manufacturing industry. A dedicated SOP for control sample management is maintained in every company.
sop-control-sample
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SOP for control sample
(1.) Objective : To lay down a procedure for Control Samples
(2.) Scope: The procedure of this SOP shall be applicable to the Quality Control Department of XYZ Pharmaceuticals
(3.) Responsibility : Quality Control Chemist
(4.) Accountability : Quality Control Manager
(5.) Abbreviations :
S.O.P. :Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
(6.) Procedure
Inspector of IPCU (In-process Control Unit) collects & Store the control samples of every finished product. Control Samples are checked for Batch No., Mfg. Dt., Exp. Dt., and Quantity of sample.
Before keeping the Control Samples in Control Section Room. All the details of Control Samples like (Product Name, Batch No., Mfg. Dt., Exp. Dt., Ref. No. Batch Size, Receipt date of Control Samples, Quantity kept, Date of disposal and Signature) are noted in Control Sample register which is maintained by Quality Control Section and then the Control Samples are stamped and signed by Quality Control Person.
Guidelines for control sample management:
Control Sample should be collected on the basis of formula NH+1 from the packing department.
The control sample shall be retained for a period of 6 months of the shelf life of the respective product.
Control sample quantity shall be equivalent to at least two analytical tests, generally, 100 units of tablet and capsules, five bottles of any dry syrup are drawn and stored in the control sample area in a methodical manner.
Control sample numbering shall being with F1/98 onwards and shall stand changed to F1/99 onwards on a yearly calendar basis.
A control sample of Raw Materials shall be stored in polythene bags with one inner label and sealed properly bearing the following label :
Material: Sample Date: Batch No. : Quantity:D/M: D/E:Mfd by:Supp. by: Signature label-format-raw-material-sample
stamp-format
A control sample of Finish products shall be stored in a control sample room in which Temp. & Humidity is controlled & record of Temp. & Humidity should be maintained.
All the containers of control sample should be stamped with the following details:
A register is maintained on daily basis to record the position of control samples.
S. No.Date of SamplingProduct NameB. No.D/MD/EB. SizeS. Qty.Control Sample No.Sampled byDate of disposalRemarkSign register-format
Control sample storage guidelines:
(6.8) Quantity of Sample used for analysis for those products, which are likely to be affected on storage, are noted in the control register.
(6.9) Control Samples should be stored for additional months after the expiry date and after completion of this period, the Control Samples are disposed of goods.
(7.0) The Control sample from each batch of the product shall be retained in a qty. which is at least twice the quantity of the drug required to conduct all the tests except sterility & pyrogens / bacterial endotoxin test. The control sample should be kept in its final pack or a simulated pack.
METHOD OF DISPOSAL:
Control Samples are disposed of as per the method described in SOP’s. The control samples of finished products tablet and capsules are de-foiled and repacked from blister strips. The tablets and capsules are packed in disposable bags and destroyed by shredding.
Liquid bottles are emptied into drums and the liquid collected is treated in the ETP plant to a drainable condition. The empty bottles and plastic jars are sent to the solid waste disposal agency.
