Documentos de Académico
Documentos de Profesional
Documentos de Cultura
2001.
Why GMP?
GMP cGMP
GENERAL REQUIREMENTS
WAREHOUSING AREA
PRODUCTION AREA
ANCILLARY AREAS
QUALITY CONTROL AREA
PERSONNEL
HEALTH , CLOTHING AND SANITATION OF
WORKERS
MANUFACTURING OPERATIONS AND CONTROLS
SANITATION IN MANUFACTURING PREMISES
RAW MATERIALS
GMP For Premises and materials
EQUIPMENT
DOCUMENTATION AND RECORDS
LABELS AND OTHER PRINTED MATERIALS
QUALITY ASSURANCE (QA)
SELF INSPECTION AND
QUALITY AUDIT
QUALITY CONTROL SYSTEM
SPECIFICATIONS
MASTER FORMULA RECORD
BATCH PACKAGING RECORDS
BATCH PROCESSING RECORDSSTANDARD
OPERATING PROCEDURES ( SOPs) AND
RECORDS
GMP FOR PREMISES
AND MATERIALS
1. GENERAL REQUIREMENTS
1.1 LOCATION AND SURROUNDINGS –
The location of the factory and it`s surroundings should be
such as to avoid risk of contamination from external environment
including open sewage , drain , public lavatory or any factory which
produces disagreeable or obnxious odour , fumes , excessive soot , dust
, smoke ,
Chemical or biological emissions.
Rest and refreshment rooms shall be separate from other areas and
shall not lead directly to the manufacturing and storage areas.
Facilities for changing , storing clothes and for washing. Separate
toilets for males and females not directly connected with
production or storage areas shall be provided. There shall be
written instructions for cleaning and disinfecting for such areas.
5.QUALITY CONTROL AREA
The labels shall carry all the prescribed details about the
product and shall be printed in bright colours and in alegible
manner. All containers and equipment shall bear appropriate
labels. Different colour coded labels shall be used to indicate
the status of a product ex. Under test , approved , passed ,
rejected . Unused coded and damaged labels and packaging
materials shall be destroyed and recorded.
14.QUALITY ASSURANCE (QA)
This is a wide ranging concept concerning all matters that
individually or collectively influence the quality of a product. It is
the totality of the arrangements made with the object ensuring that
products are of the quality required for their indented use. Quality
assurance ensure that –
1. Adequate arrangements are made for manufacture , supply
and use of correct starting and packaging materials.
• The finished product is correctly processed and checked in
accordance with established procedure.
15. SELF INSPECTION AND
QUALITY AUDIT
The concept of self-inspection shall be followed to evaluate the
manufacturers compliance with GMP in all aspects of production
and quality control. The manufacture shall constitute a team of
independent , experienced , qualified persons from within or
outside the company who can audit objectively the
implementation of methodology and procedure evolved. Written
instructions for self-inspection shall be drawn up which shall
include the personnel , premises including personnel facilities ,
maintenance of buildings and equipment, label control etc.
16. QUALITY CONTROL SYSTEM
Every manufacturing establishment shall establish its own QC
laboratory manned by qualified and experienced staff.
QC is defined as ,"The regulatory process through which industry
measure actual quality performance .