SOPs

SOP on Intermediate and finished product Analysis and Approval

ABHA

SOP on Intermediate and finished product  Analysis and Approval

To lay down the procedure for testing Intermediate samples and finished product.

Procedure:

Quality Assurance personnel shall collect the sample of finished and intermediate products and affix the “sample for analysis” label along with a Sample Intimation Slip filled with all details. The finished product shall be handover with a sample intimation slip and the intermediate product with a sample intimation slip in the Quality Control department.

The quality control officer or above shall record information on the finished product in the log register and that of the Intermediate product in the intermediate product register.

AR No. of the product shall be generated

The quality Control Executive / Nominee shall allocate the sample to the chemist for analysis.

Quality Control Chemist shall perform the analysis as per standard test procedure of the respective product, and record the results and calculation in respective worksheets.

The quality Control Executive / Nominee shall review and verify the complete analytical results and forward them to the Head of Quality control.

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After approval by the Quality Head, the officer shall make the certificate of analysis and records the date of release in the sample log register, and intimate to the Quality Assurance department of the release of the batch.

If the batch is not packed within 60 days from the date of manufacturing then re-sampling and retesting shall be done prior to release for packing.

In case, of Specification (OOS) results, the Quality control shall inform to Manager of Quality Assurance. The matter shall be investigated for Out Of Specification (OOS) results and the final decision shall be taken by the Manager of Quality Assurance.

List of Annexures / Formats:

Finished product control register

Intermediate product control register

Finished product control register

  • Product Name
  • Batch No.
  • Batch Size
  • Mfg. Date
  • Exp. Date
  • Sampled Quantity
  • Sampled by / Date
  • Date of Analysis
  • Date of Completion
  • A.R No
  • Analyzed by

Intermediate product control register

  • Product Name
  • Batch No.
  • Batch size
  • Mfg. Date
  • Exp. Date
  • Stage
  • Sampled Quantity
  • Sampled by
  • Date of Analysis
  • Date of Completion

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ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits 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. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube