Procedure For sampling of in-process product

STANDARD OPERATING PROCEDURE

Title: Procedure For a sampling of in-process product

Department : Quality Assurance

  • OBJECTIVE
    • To lay down the procedure for sampling of in-process product.
  • SCOPE
    • This procedure is applicable to production and QA departments for sampling of in-process products for various stages of Tablet, Capsule and liquid products.
  • RESPONSIBILITY
      • Officer/Executive – IPQA – To collect sample at different stages and completion of document activity for the same.
      • Officer/Executive-Production – To intimate IPQA for performance of sampling activity.
  • ACCOUNTABILITY
    • Manager-Production
    • Manager-Quality Assurance.
  • PROCEDURE
    • Collection of sample after equipment cleaning:
      • After equipment cleaning, production department shall intimate to IPQA, IPQA officer shall take the rinse / swab sample from equipment.
      • In case equipment in which water sampling is not possible to be taken for analysis, in that case take a clean swab wet with Purified water and select the area 10x10cm2 at two or three positions (Which comes in contact with the drug) on the surface of the equipment.
      • Note: Swab shall be taken from the part of production line which having the most contact with the product like from near the basement or first fitting at the production line.
    • Collection of samples in tablet product:
      • Initially samples shall be withdrawn after final mixing, i.e. after completion of granulation stage with sample intimation.
      • Sample of in-process stage (Compression, Coating and Packing) shall be collected at initial middle and end stage.
      • After collection of sample for each stage, composite sample along with sample intimation shall be sent to QC for analysis.
  • Collection of samples in Capsule product:
    • Filled capsules shall be collected at initial, middle and end stage and shall sent to QC department along with sample intimation.
    • After packing samples shall be collected same as, initial middle and end stage.
    • Samples shall be sent to QC by making composite sample.
  • ABBREVIATIONS

  SOP       –   Standard Operating Procedure.

  QA        –   Quality Assurance.

  • ATTACHMENTS
Sr. No. Title  Attachments
Sample intimation Attachment-I
Sample collection record Attachment-II
  • DISTRIBUTION LIST
Sr. No. Copy No. Department
1 Quality Assurance
2 Quality Control
3 Quality Control – Microbiology
4 Production
5 Engineering & Utility
6 Personnel & Administration
7 Warehouse
8 VP-Plant & Operations

 

ATTACHMENT-I

SAMPLE REQUEST REQUISITION  

Ref. No.: ………………………….                                                                        Date: ………………………

To,

Quality Control Department,

SAMPLE STAGE:         Bulk / Semi-finished / Finished product

Please collect the sample from the production department of following details for complete analysis:

Product Name               : ______________________________________

Batch Number               : ____________________ Batch Size  : ___________________

Mfg. Date                      : ____________________ Exp. Date : ___________________

Sample Qty.                  : ____________________

Composition                  : ______________________________________________________________

Please issue the test report at the earliest.

From: Production Department                                                    Received by: Quality Control

Signature and Date                                                                          Signature and Date

Name                                                                                                  Name

(Prod.-Officer/ Executive)                                                               (QC-Officer/ Executive)

ATTACHMENT-II

SAMPLE COLLECTION RECORD

Section: ……………………………………….                                                                                      

Sample Stage: …………………….…… 

Sr. No. Name of Product Batch No. Batch Size Mfg. Date Exp. Date Ref. No. Sample Qty. Sample collected by Sample received by Remark

 

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