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
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment