GMP - יועצים לבקרת איכות / כללי יצור נאותים

ISOPOINT QCS

דף הבית

תחומי היעוץ

נושאים נבחרים

צור קשר

יועצים להסמכה וניהול מערכות איכות

ISO 13485

רשימת תיוג לכללי יצור נאותים - דוגמא חלקית לתעשיית קוסמטיקה וטיפוח GMP

GFGFGTYTY

1.	Personnel	Compliance
1.1	Does the head of production have a scientific or technical education background?
1.2	Has the head of quality control received basic technical training?
1.3	Are sufficient qualified staffs available for production?
1.4	Are sufficient qualified staffs available for quality control?
1.5	Are organigrams available?
1.6	Are job descriptions/function descriptions available in the organization?
1.7	Are employees regularly trained in industrial hygiene, operation of new machinery/new manufacturing methods, Cosmetic-GMP?
1.8	Are written training programs available in this context?
1.9	Are records kept of implemented training measures?
1.10	Are there instructions that personnel report to management illness or open lesions that might effect product quality?
1.11	Do clothing regulations apply and is there a written policy (e.g. including protective clothing for visitors)?

2.	Buildings	Compliance
2.1	Are areas with differing hygiene requirements clearly separated?
2.2	Are measures taken to prevent intrusion by insects and small rodents?
2.3	Is the condition of the walls, ceilings and floors such that no impairment ליקויof the product can occur?
2.4	Is the condition of the building such that cleaning can be carried out thoroughly and easily?
2.5	Is the condition of the heating, lighting and ventilation systems such that no impairment of the product can occur?

2.6	Is there enough space to ensure correct deployment פריסה of the technical equipment and raw materials, so that no mix-ups can occur?
2.7	Is the condition of the storage area such that storage regulations can be complied with?
2.8	Is an unequivocal חד משמעיassignment or separation of the storage sites guaranteed?
2.9	Is there a segregated area for the storage of special materials (inflammable, water-polluting, toxic)?
2.10	Are raw materials reloaded on to aluminum or plastic pallets on hygiene grounds?
2.11	Is the application of the first-in first-out principle guaranteed?
2.12	Are there adequate sanitary facilities where staff can wash and disinfect their hands?
2.13	Are the sanitary facilities accessible directly from the production areas?
2.14	Is the condition of the sanitary areas such that they can be cleaned and disinfected easily?
2.15	Are there separate staff areas available for eating/ Drinking /smoking?

3.	Technical facilities	Compliance
3.1	Can the production lines and equipment be easily cleaned and disinfected?
3.2	Is the material compatibility between equipment parts and raw materials and/or cleaning and disinfecting agents known and is this taken into account?
3.3	Are the production lines designed in such a way that contamination is avoided during the manufacturing process?
3.4	Are clean-in-place(CIP) procedures used for cleaning production lines?
3.5	Are scales and measuring equipment regularly checked, calibrated and adjusted?

דפי מידע

הבהרה : השימוש במידע באתר זה הינו באחריות המשתמש בלבד. אין להסתמך על התכנים והמידע המפורסמים באתר כמקור רשמי. אין להתייחס למידע כייעוץ, או ככלים למיסוד מערכות איכות בארגון. מיסוד מערכות איכות מחייב העמקה בהבנת הדרישות ובחירה של כלים ושיטות בהתאם לסוגי התהליכים הספציפים בכל ארגון. כל הזכויות שמורות. אין להעתיק ואין לפרסם תכנים ומידע המופיעים באתר ללא אישור בכתב

J.E.