10:01 PM
Leo Group India
The first WHO draft text on GMP was prepared in 1967 by a group of
consultants, at the request of the Twentieth World Health Assembly. The
revised text was discussed by the WHO Expert Committee on Specifications
for Pharmaceutical Preparations in 1968 and published as an annex to
its twenty-second report.
The text was then produced in 1971 as
Supplement to the second edition of The International Pharmacopoeia.In
1969, when the World Health Assembly recommended the first version of
the WHO Certification Scheme on the Quality of Pharmaceutical Products
Moving in The International Commerce in resolution WHA22.50, it was
accepted and at the same time the GMP text became an integral part of
the Scheme. Revised versions of both the Certification Scheme and the
GMP text were adopted in 1975 by resolution WHA28.65. Since then, the
Certification Scheme has been extended to include the certification of:
Veterinary products administered to food producing animals – starting
with materials for use in dosage forms. The products are subjected to
control by legislation in both the exporting Member State and the
importing Member State based on information of safety and efficacy. New
types of guidelines have appeared in recent years. Another important
development in the industry at Large is the appearance of the guidelines
of the International Organization for Standardization (ISO),
specifically the ISO 9000 to 9004 standards for quality systems.What schedule M says actually
Schedule M1: Deals with the requirements of factory premises for manufacturing of Homeopathic preparations.
Schedule M2: Deals with the requirements of premises, plant and equipment for manufacture of cosmetics.
Schedule M3: Deals with the requirements of premises, plant and
equipment for manufacture of Medical devices. GMP regulations are used
by manufacturers to produce and test products that people use. GMP also
implies to the veterinary products.
Most countries have their own GMPs for drug and medical device manufacturers. GMPs are a
directive that describes the methods, equipment, facilities, and controls required for producing:
Human pharmaceutical products and veterinary products.
Biologically derived products.
Medical devices.
Processed foods.
Posted in: schedule-m
0 comments:
Post a Comment