QAS-003 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 199

22.5 attachment form

abc Pharmaceutical comPany LEVEL 3

SOP No.: QAS-003

Issued on:

Revision No.:

Initiator name:

Annexure I
Sampling Stage and Sample Amount for Different Products

sampled Quantity and type of container

Physical microbiological

s.
no.

chemical
bulk Product name bulk (g) container bulk finished bulk finished container

1. Paracetamol 125 mg - FB - 2 boxes (40 blisters) - FP

1 × 100 Supp. 1 × 100 Supp. per day

2. Paracetamol 250 mg - 1 × 100 Supp. FB - 2 boxes (40 blisters) - 1 box/100 Supp. per day FP

3. Paracetamol 500 mg - 1 × 100 Supp. FB - 2 boxes (40 blisters) - 1 box/100 Supp. per day FP

4. Diclofenac 12.5 mg - 1 × 100 Supp. FB - 2 boxes (40 blisters) - 1 box/100 Supp. per day FP

5. Diclofenac 25 mg - 1 × 100 Supp. FB - 2 boxes (40 blisters) - 1 box/100 Supp. per day FP

6. Diclofenac 50 mg - 1 × 100 Supp. FB - 2 boxes (40 blisters) - 1 box/100 Supp. per day FP

7. Paracetamol 120 mg suspension - 4 × 200 mL ACB - 20 bottles FP Paracetamol 120 mg suspension -

8. Paracetamol 250 mg suspension - 4 × 200 mL ACB - 20 bottles FP Paracetamol 250 mg suspension -

9. Metronidazole 125 mg/5 mL - 4 × 200 mL ACB - 20 bottles FP Metronidazole 125 mg/5 mL -

10. Ciprofloxacin 200 mg/5 mL - 4 × 200 mL ACB - 20 bottles FP Ciprofloxacin 200 mg/5 mL -

11. Fusidic acid 2% - 100 g PC - 20 tubes Tubes 1 × 50 g PC

12. Mikacin sulfate - 100 g PC - 20 tubes Tubes 1 × 50 g PC