Seminars , Assignment # 1 and 2: Date: 22/ 02/2020

Dear All,,

Each Student is required to prepare the following documents for the assigned drug product:

1. Master/Manufacturing Formula
2. Specifications of API
3. Specifications of Finished Product
4. Manufacturing/Processing Instructions & Record
5. Packaging Instructions & Record
6. Stability Protocol for Accelerated & Long-term stability studies.

Sr# Student Seminar Drug Product Pack Batch Size SOP

1 Anwar ICH Guidelines – Vitamin B12, 5 ampoules/box 20,000 Cleaning of Super
Quality Risk 1000µg/1ml injection Ampoules Mixer Granulator
Management
2 Walaa Impurities – Diclofenac Sodium 50mg 30 tablets/box 500,000 Tablets Dispensing/Weighing
Guideline for Enteric Coated Tablet Starting Materials for
Elemental Impurities Production Batch
in medicinal products
3 Maysoon GMP for Bulk Etodolac400mg 30 tablets/box 200,000 Tablets Sampling of Starting
Pharmaceutical IRTablets Materials
Excipients
4 Niemeh Technology Transfer Tadalafil 10mg Tablets 10 tablets/box 100,000 tablets Recall of Finished
Products
5 Haya Qualification of Acyclovir 200mg Tablets 60 tablets/box 150,000 Tablets Testing Starting
Water for Materials
Pharmaceutical Use
Systems

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Seminars , Assignment # 1 and 2: Date: 22/ 02/2020

6 Manar Qualification of Risperidone 1mg Tablets 30 tablets/box 600,000 Tablets Cleaning of

Steam Sterilization Production Garments
Autoclaves and work clothes
7 Samah Site Master File, levofloxacin 500mg 20 tablets/box 200,000 Tablets Training of
Sample Tablets Production Personnel
8 Majd APIs Supplier Lidocaine 5%, topical 30g/tube 20,000 tubes Disinfection of
Approval Gel Production
Premises /rooms
9 Suhad Biowaiver Guidelines Diclofenac Potassium 30 tablets/box 500,000 Tablets Calibration of QC
– ICH M9 Guideline 50mg Tablets Balances
10 Good Storage & Paracetamol 150mg 6 suppository/Box 20,000
Distribution Practices Suppositories suppositories
for Drug Products