Libyan Government Form No: LY/MOH/M&MD/03/03
Ministry Of Health ApplicationNo : ......
Pharmacy And Medical Devices-
Department Date Of Submission: / /
DD MM YY Part III / Specific Information/Production And Premises
Please check which operations are carried out in the production area:
Synthesis Biosynthesis Sterilisation Mixing
Genetic Engineering Extraction Filling Blending
Final packing
Others (Please specify)
Please specify whether Manufacturing is carried out
Non sterile Sterile Both
Please list capacities per each process section:
Are there any other products manufactured in the same premises except pharmaceuticals and medical devices:
Yes No
In case yes, are these products:
Para Pharmaceuticals Cosmetics medical devices
Others(Please Specify)
Please indicate whether all process steps are performed in the Manufacturing premises or if process steps are out sourced.
Process steps out sourced:
Are Goods manufactured in your premises requiring special precautions. please indicate.
Personnel
Plant/Production Manager
Name / Title / Since when employed as Plant/Production manager
Qualification
CV attached
IPC
Is an IPC available in production area.
YES NO
Who is responsible for the IPC.
Name / Qualification / Position
1. In Concerning pharmaceuticals Registration:
DOSAGE FORMS
Which dosage forms are manufactured in the subject of application:
Solids Semi Solids Liquids
Others (Please specify)
For Solids:
Tablets S/C Tablets F/C Tablets HG Capsules SG Capsules
Granules Powder
Others (Please specify)
For Semi-Solids:
Ointments Creams Lotions Suppositories
Others (Please specify)
For Liquids:
Oral Liquids ExternalLiquids SterileLiquids Ampoules
Others (Please specify)
Others:
2. In Concerning Medical Devices Products:
Describe in Brief Stages of production Lines Available :
Contamination
Please explain in brief which measures ,including flow of materials are undertaken to prevent cross-contamination in regard to
- Handling of Substances
- Personnel
- Equipment
- Labelling (please provide a sample of labelling in Arabic/English)
How microbiological contamination in your premises Are monitored/avoided. Please give brief explanation on?
- Environmental
- Equipment
- Personnel
Building
Year of Construction: / Year of latest Design:
Construction principles:
HVAC
Is the plant equipped with a HVAC system.
YES NO
If Yes, please specify standards and norms which apply for the design of the system:
Information about water source and actions taken to produce the Quality on water required:
Which environmental parameters are controlled and in which frequency.
PARAMETER / FREQUENCY
Signature of responsible Official or Agent / Type Name and Title
Place / Date
Note: This Application Form is to be Filled by The Applicant by Typing only.
Forofficialuseonly.
ADOPTIONOF PHARMACYAND MEDICAL DEVICES DEPARTMENT
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