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  - Initially samples shall be withdrawn after final mixing, i.e. after completion of granulation stage with sample intimation.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.

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: …………………….……