Date: 13.09.

2020
Drugs Audit Report-2020
A meeting was held with DGDA person on 10.09.2020 at Managing director Office room, Factory at 3.00 Pm. Following persons were present in the meeting.
1.Mr.Md Salahuddin Deputy, Director, DGDA
2.Mr. Saikat Kumar Asst. Director, DGDA
3.Mrs. Farzana Shabnam Boishakhi Drug Superintendant,DGDA
4. Syed Amirul Islam GM , Operations
5. Mashihur Rahman Plant Manager
6. Md. Jahangir Alam Marketing Manager-1
7. Md. Abdul Mottalib Manager, QA
8. Md. Mahabub Morshed Deputy Manager, Production
9.Md.Niamat Hossain Asst. Manager, QC
10. Md. Raisul Alam Sr. Executive, Engineering Dept.
11. Md. Solayman Hossain Sr. Executive, Regulatory affairs

Following technical discussions were held and decisions taken are appended below:

Sl. No. Points discussed Remarks

1. HVAC System are to be incorporated in both granulation area (G-1 &G-2)
2. Dedicated Executive to be recruited in Cephalosporin & Penicillin area . Dedicated manpower, Dress and its washing &
drying facility and dining must remain within the area.
3. Reference standard are to be procured for all generic drugs.
4. IPQC Lab are to be made section wise ie, Penicillin, Cephalosporin and General section(Solid, Liquid & dry syrup)
5. APQR activities are to be started as per SOP.
6. Training for Senior Executives and Managers is essential (Domestic and abroad)
7. Segregated store is required for Flammable materials like IPA, Methylene Chloride, Methanol etc.

8. Gas Chromatography (GC) is required for IPA, Sorbitol ,Glycerol and other volatile materials.
9. Assay of Kilgerm75% IPA Hand Rub to be done by Govt./Private organization like BCSIR, Plasma Plus etc and test report
to be submitted to DGDA until GC is procured.
10. Air curtain to be installed in-front of Officer’s change room.
 11. All wooden furniture and fixtures in the production area are to be replaced by ss furniture and fixtures
12. Metal detector is required for Tablet Compression Machine and Auto capsule Machine.
13. Segregated manufacturing facilities are to be created for Kilgerm Hand Rub .
14. Dust collector in Penicillin area is required(Bag in bag out or Acid –Base treatment)
15. Air sampler, Particle counter and Fungal Incubator is required in Microbiology Dept.
16. Microbiology Dept. are to be controlled by AHU/HVAC System.
17. Dress change facility to be created in all dispensing and sampling booth.
18. Floor of warehouse are to be smooth and environment to be controlled by either AHU or AC so that Temperature remain
within 250C.

_________________
Md. Abdul Mottalib
Manager, Quality Assurance

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