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SOP on Sampling of Intermediates and Finished Products

  • OBJECTIVE :To lay down a procedure for sampling of intermediate(blend/core/coated/capsules) and finished products (packing)during manufacturing operations.
  • SCOPE:This SOP shall be applicable to the IPQA in Quality Assurance Department.
  • RESPONSIBILITY: In process Quality Assurance Executive/Officer shall be responsible for follow the procedure mentioned in the SOP.
  • ACCOUNTABILITY:Head Quality Assurance shall be accountable for compliance of this SOP.
  • PROCEDURE:
  • PREPARATION:
  • On completion of intermediate / finished product stage, check that the BMR /BPR is completed and signed up to that stage and all the manufacturing steps are followed and documented, including stage wise yields.
  • Production executive /officer will rise the Testing Request Form (Annexure-I) and give the intimation to IPQA for sampling.
  • Ensure the availability of clean spatula, self-sealing polybags, labels, and sampling rod.
  • Prepare an “INPROCESS SAMPLE” label (Annexure – II), which should contain the following information.
  1. Product
  2. Batch No.
  3. Quantity sampled
  4. Stage
  5. Test to be conducted
  6. Sampled On  & Sampled By
  7. Sample submitted at (Time)

Ciprofloxacin Hydrochloride 500 mg Tablets (drugsformulations.com)

  •  Affix the label on the container to be used for sampling before keeping it in self sealing polybag in case of blend,uncoated / coated tablets and capsules.
  • Wear fresh latex gloves, before sampling.
  • Ensure that all the IPC/Bin (HDPE) containers have affixed labels with correct product and batch details.
  • SAMPLING OF FINAL BLEND, CORE/ COATED TABLETS AND CAPSULES.
  • SAMPLING OF FINAL BLEND
  • Open the In Process Container (IPC) of the final blend and take equal quantity of samples from different locations from different IPCs using a cleaned Sampling rod (Total quantity of sample should approximately be near to the quantity mentioned in Table No. I)
  • Collect the sample in self-sealing polybag. Put this polybag into another self-sealing polybag bearing label of complete pool sample details.
  • Ensure proper closing of the container after the sampling operation.
  • Submit the sample along with Test request form and make an entry in the In process sample register at QC.
  •  Affix ‘To be cleaned’ label on spatula/ sampling rod as per annexure III and send it for washing .
  • SAMPLING OF CAPSULES/ CORE AND COATED TABLETS
  • Collect core/coated tablets from IPC/bin (High Density Poly Ethylene) in such a manner that it must cover the start, middle and end of the batch. If the batch is lot wise then cover the lots and composite it in a self-sealing polybag.
  • Open the polybags of the bins of the core/coated tablets and take out equal quantity of samples from different locations of different bins (Total quantity of sample should approximately be near to the quantity mentioned in Table No.I).
  • Collect the sample in self-sealing polybag. Put this polybag into another self-sealing polybag having the label with complete pool sample detail.
  • Ensure proper closing of the polybags and containers after the sampling operation.
  • Submit the Sample along with Test request form(Annexure-I) and make an entry in the In process sample register at QC. 

                                                 TABLE – 1

Dosage Form Quantity (Approximately)
Final (Blend) 60 g
Core tablets 100 tablets
Coated tablets 100 tablets
Capsules 100 Capsules

Note :In case of microbiological testing is required collect about 10 g extra tablets/capsules in a self-sealing double poly bag.

SAMPLING OF FINISHED PRODUCTS:                                              

  • Withdraw an equal quantity of samples from shippers it will represent, start, middle & end of the batch
  • The sample quantity shall be equivalent to the quantity mentioned in Table No. 2.
  • Send the samples to QC along with test request form and make entry in the finished product register.

                                                                TABLE – 2 

Dosage Form Sample Quantity (Minimum)
Tablets 100 Tablets
Capsules 100 Capsules

   Note:

  1. In case of process optimization batches sampling as per optimization plan.
  2. Incase of validation optimization batches, sampling as per validation plan.
  • FORMS AND ANNEXURE:
  • Test Request form – Annexure – I.
  • Label of In Process sample – Annexure – II.
  •  “To be cleaned” label – Annexure – III
  • HISTORY
    Date   Revision Number
    Reason for Revision
    00 New SOP

 

Cetirizine Dihydrochloride 10 mg Tablet (drugsformulations.com)

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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