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Wednesday, May 12, 2010

Standard Operating Procedure Title: Sampling of In-process/Finished product

Purpose:
• It is established to provide the guidelines for the sampling of In-process/Finished Products.
2. Scope:
• It is applicable to QA Department.
3. Responsibilities:
• Quality Control Manager
• Quality assurance Officer
4. Procedure:
After receiving “ Intimation for in-process/Finished Sampling from production Department,QA Officer checks the product to be sampled according to the manual for Product specification. “ Sampled” & “ Under test” stickers are pasted over the container from where sample is to be taken
Sampling Quantity
 Liquids
100 ml in a clean dried beaker.
 Powder/Granules
10-20 Grams in poly bags.
 Tablet
30-50 Tablets in poly bags.

 Capsules
30-50 Capsules in poly bags.
 Gel/Ointment
50-100 Grams in clean dried beaker.
 Injectable
Inprocess: 100 ml (in case of bulk liquid)
30-50 units (In case of filled /sealed units)
Finished: 2 x 10 Units (For commercial)
20 x 1 Units (For Sample)
Quality Record(s)/Form(s)

The following quality records shall be generated in accordance with the procedure for Control of Company Quality Records (4.12).

Required Record Form No.
Sampled QF/059/01
Under Test QF/057/01

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