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Collection, Storage and Control of Control Samples for Drug Products

  • OBJECTIVE :To lay down a procedure for collection, storage, retrieval and disposition of Control samples of drug products.
  • RESPONSIBILITY :Quality Assurance Officer for collection, storage, retrieval and disposal of Control samples.
  • Head of  Quality Assurance Department to ensure compliance.
  • PROCEDURE :Every batch/lot of each drug product in all forms of its packing shall be sampled for Control sample separately.
  • During  the  primary  packing  of  drug  product the concerned QA Officer shall collect Control  samples that are representative of batch of drug product. The Control sample  shall  be  collected  at equal   intervals throughout  primary packing operation of the batch.
  • The quantity of Control samples should be at least twice the quantity necessary to perform all the required tests.
  • The Control samples shall be stored in the same immediate container-closure system in which the drug product is to be marketed.
  • The Control samples shall be stored under conditions consistent with the product labeling.
  • If the drug products are bulk packed, then the Control samples shall be kept in the same type of packing like that of bulk packing but in small scale.
  • The Officer-QA shall enter the details in “Control sample register ” for drug products.
  • For all  drug products , the Control samples shall be retained for not less than one year after the expiration date of the drug product.
  • For drug product that is exempted from bearing an expiration date, the Control sample  must  be  retained for not less than 3 years after the batch of the drug product is distributed.
  • Control samples shall be examined visually at least once a year for all commercial batches for evidence of  deterioration, unless  visual  examination  would  affect  the integrity of the Control samples (containers).
  • The results of periodic examination of Control samples shall be recorded with other stability data of drug product.
  • Any evidence of Control sample deterioration shall be investigated and documented.
  • At least one packed unit from each lot is to remain unopened in the event chemical testing has to be performed.
  • In case of retrieval of any Control sample the concerned personnel shall fill the “Control sample issue request”  and get the approval from Head of Quality Assurance Department Officer-QA shall  issue  the  drug product requested and fill the request.
  • After the completion of retention period, the concerned Officer-QA shall destroy the sample by incinerating and enter the disposed off date and signature in the Control sample register for drug products.
  • Forms and Records
    • NA
  • Distribution
    • Master Copy – Documentation Cell (Quality Assurance)
    • Controlled Copies – Quality Control, Production, Stores,Quality Assurance.
  • History
Date Revision Number Reason for Revision
00 New SOP










About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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