STANDARD OPERATING PROCEDURE Reference Samples (Finished Packs)

Purpose:

It is established to keep reference sample of 1st three commercial batches for the period of shelf life plus one year.

2. Scope:

It is applicable to R&D Department.

3. Responsibility:

1. Manager R&D
2. Assist. Manager R&D
3. Analyst R&D
4. QA Manager
5. Production Manager/Production Pharmacist

4. Procedure

1. QA takes out finished packs as soon as one of the 1st three commercial batches starts.
2. If the samples are of more than one pack, these must be wrapped with rubber band and the packs must clearly indicate batch number.
3. QA deptt acknowledges the sample receiving on the control sample receipt.
4. Quantity of the samples (finished packs) for each item is mentioned below:









Tablets-----------------------------------150 Tablets
Capsules--------------------------------150 Capsules
Dry Suspension------------------------18 Bottles
Sterile Dry Powders Injections-----18 Vials
Sterile Liquid Injections---------------60 Ampoules/vials
Cream/ Ointments---------------------18 tubes
Ophthalmic----------------------------- 60 unit packs (Droppers)
Sachets (Dry Powders) -------------18 Packs

5. Retain the samples through out shelf life and one year Additional or as per local health authorities requirement.

5. Quality Record Form
The following Quality Records should be generated in accordance with the procedure for Control of Company quality Record.
Required Record Form Reference No.
Control sample receipt QF/114/01