📘 ❞ REQUIREMENTS OF GOOD MANUFACTURING PRACTICE ❝ كتاب

كتب علمية - 📖 كتاب ❞ REQUIREMENTS OF GOOD MANUFACTURING PRACTICE ❝ 📖

█ _ 0 حصريا كتاب ❞ REQUIREMENTS OF GOOD MANUFACTURING PRACTICE ❝ 2025 PRACTICE: من كتب علميةREQUIREMENTS REQUIREMENTS OF GOOD MANUFACTURING PRACTICE GUIDELINE COLOUR TEXT 1 THERAPEUTIC GOODS ADMINISTRATION (TGA) 2 MEDICINES CONTROL AGENCY (MCA) 3 SCHEDULE M 4 COUNCIL (MCC) 5 WORLD HEALTH ORGANIZATION (WHO) NOTE : (The number mentioned against each point is clause no as per respective guidelines) 1 BUILDINGS AND GROUNDS TGA: a General 101 Buildings should be located, designed, constructed, adapted and maintained to suit the operations carried out in them Except where special precautions are taken isolate an interior manufacturing space, buildings should sited away from incompatible activities such those that generate chemical or biological emissions 102 Buildings, including receiving despatch areas, constructed maintained so protect effects of weather ground seepage entry harboring of vermin, birds, pests pets Cavities voids not present unless sealed provided with access for pest control 103 Animal houses isolated production with separate entrances air handling facilities, comply current edition NH& MRC CSIRO AAC Code of practise care use animals experimental purposes 104 Grounds established so minimize ingress into buildings dust, soil other contaminants orderly condition b Pipes, ducts service area 105 Pipelines carrying services products between rooms areas identified by colour by standard markings at suitable intervals direction flow shown Particular product pipelines inter connected connectable a manner invites cross contamination mix up “Dead legs” (in which circulation cannot occur) minimized 106 In – * Extraction designed cleanable prevent condensate accumulated dust from falling back equipment * There recesses cleaned a minimum projecting ledges, shelves, cupboards, pipes, fixtures fittings * Exposed overhead roof joists, pipes avoided Where they unavoidable, special cleaning procedures schedules written followed touch walls, but suspended supported brackets, sufficiently separated allow thorough Opening floors ceilings through piping, ducting non structural items pass have removable covers permit Light fittings located collect deposit 107 Production normally contain machinery, its associated ductwork or pipe work, except connect directly Rooms areas علمية مجاناً PDF اونلاين الطريقة العلمية أو المنهج العلمي الثقافة عبارة عن مجموعة التقنيات والطرق المصممة لفحص الظواهر والمعارف المكتشفة المراقبة حديثا من ضمن محتويات القسم العلماء‏ , أحيائية,‏ بيئية لا خيالية,‏ رياضيات,‏ طب‏, علم والكثير

إنضم الآن وتصفح بدون إعلانات
REQUIREMENTS OF GOOD MANUFACTURING PRACTICE
كتاب

REQUIREMENTS OF GOOD MANUFACTURING PRACTICE

REQUIREMENTS OF GOOD MANUFACTURING PRACTICE
كتاب

REQUIREMENTS OF GOOD MANUFACTURING PRACTICE

حول
المتجر أماكن الشراء
مناقشات ومراجعات
QR Code
عن كتاب REQUIREMENTS OF GOOD MANUFACTURING PRACTICE:
REQUIREMENTS OF GOOD MANUFACTURING PRACTICE من كتب علميةREQUIREMENTS OF GOOD MANUFACTURING PRACTICE

REQUIREMENTS OF
GOOD MANUFACTURING
PRACTICE
GUIDELINE COLOUR OF TEXT
1. THERAPEUTIC GOODS ADMINISTRATION (TGA)
2. MEDICINES CONTROL AGENCY (MCA)
3. SCHEDULE M
4. MEDICINES CONTROL COUNCIL (MCC)
5. WORLD HEALTH ORGANIZATION (WHO)

NOTE : (The number mentioned against each point is clause no. as per respective guidelines)
1. BUILDINGS AND GROUNDS
TGA:
a. General
101. Buildings should be located, designed, constructed, adapted and maintained to suit the operations
carried out in them.
Except where special precautions are taken to isolate an interior manufacturing space, buildings
should be sited away from incompatible activities such as those that generate chemical or biological
emissions.
102. Buildings, including receiving and despatch areas, should be designed, constructed and maintained
so as to protect against the effects of weather or ground seepage and the entry and harboring of
vermin, birds, pests and pets. Cavities and voids should not be present unless sealed or provided with
access for pest control.
103. Animal houses should be isolated from production areas, with separate entrances and air handling
facilities, and should comply with the current edition of the NH& MRC/CSIRO/AAC Code of
practise for the care and use of animals for experimental purposes.
104. Grounds should be established and maintained so as to minimize ingress into the buildings of dust,
soil or other contaminants and should be maintained in an orderly condition.
b. Pipes, ducts and service area
105. Pipelines carrying services or products between rooms or areas should be identified by colour or by
standard markings at suitable intervals and the direction of flow shown.
Particular care should be taken that product pipelines are not inter-connected or connectable in a
manner that invites cross-contamination or product mix-up.
“Dead legs” (in which circulation cannot occur) should be minimized.
106. In production areas –
Extraction ducts should be designed to be cleanable and to prevent condensate or accumulated dust
from falling back into product or equipment.
There should be no recesses that cannot be cleaned and a minimum of projecting ledges, shelves,
cupboards, pipes, fixtures and fittings
Exposed overhead roof joists, pipes and ducts should be avoided. Where they are unavoidable,
special cleaning procedures and schedules should be written and followed.
Exposed pipes should not touch walls, but be suspended from or supported by brackets, sufficiently
separated to allow thorough cleaning.
Opening in walls, floors or ceilings through which piping, ducting or other non-structural items
pass should be sealed or have removable covers that permit cleaning.
Light fittings should be located and/or sealed so as not to collect and deposit contamination.
107. Production areas should not normally contain service machinery, or its associated ductwork or
pipe-work, except where the ducting or pipes connect directly to equipment. Rooms or areas
الترتيب:

#67K

9 مشاهدة هذا اليوم

#59K

5 مشاهدة هذا الشهر

#20K

12K إجمالي المشاهدات
عدد الصفحات: 230.