Escolar Documentos
Profissional Documentos
Cultura Documentos
MANUFACTURING
General Requirements
Production in clean areas
Airlocks for entry
Personnel entry.
Material entry
Separate areas for operations
Component preparation
Product preparation
Filling
Sealing etc
Level of cleanliness
Filtered air
Air classification: Grade A, B, C and D.
Laminar air flow:
Air speed (horizontal versus vertical flow)
Number of air changes
Air samples
Conformity to standards
Work station and environment
Barrier technology and automated systems
Dr. Tushar Gohil, S.L.P.T.P.M.C.,
Amreli
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(SMALL
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cardboard
wrappings of primary packaging materials shall be done in the decartoning areas which are segregated from the washing areas.
Wooden pallets, fiberboard drugs, cardboard and other particle
shedding materials shall not be taken inside the preparation areas.
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[3] Garments
The garments-made of non-shedding and tight weave material, single
piece with fastenings at cuffs, neck and at legs to ensure close fit.
Trouser legs shall be tucked inside the cover boots. Design-include a
hood (head-cover) or a separate hood which can be tucked inside the
over-all. Zips (if any) shall be of plastic material.
Gloves-made of latex or other suitable plastic materials & long
enough to cover wrists completely and allow the over-all cuff to be
tucked in.
footwear- of suitable plastic or rubber material, daily cleaned with a
bactericide. Garment changing procedures shall be documented and
operators trained in this respect.
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and
LVPs
obviously
requires
different
space
considerations.
All the production equipment has container size limitations- large
container requires large equipments and more space.
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will
require
means
of
maintaining
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can
prevent
or
lessen
many
future
problems,
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REFERENCES
www.GMP.online.coms
Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth
Avis, Leon Lachman, Vol-1.
Pharmaceutical dosage forms (Parenteral Preparation) by Kenneth
Avis, Leon Lachman, Vol-2
Drugs & Cosmetics Act 1940.
www.ispc.org
www.whqlibdoc.who.org
The theory and Industrial pharmacy by Leon Lachman, Third
edition
Aseptic Pharmaceutical Manufacturing by M.J.Groves
Pharmaceutical science by Remington, 20th edition
Pharmaceutical process Validation by Loftus & Nash: 29-90.
Sterile Pharmaceutical Manufacturing by Groves Gisan.
www.fda.gov.
American Journal of Hospital Pharmacy, Vol. 38, Issue 8, 11441147
Dispensing for pharmaceutical students; 10 th edition; by:-S J
Carton
www.dwscientific.co.uk
www.pharmamachines.com
www.bascotech.com
S.L.P.T.P.M.C.,
www.getthatmag.com Dr. Tushar Gohil,
Amreli
www.fabtecheng.com
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Thank You
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