別紙（1）PIC／S GMPガイドライン パート1

1 1 C H AP T E R 1 P H AR M AC E U T I C AL Q U AL I T Y S Y S T E M P R I N C I P L E T h e h o l d e r o f a M a n u f a c t u r i n g A u t h o r i s a t i o n m u s t m a n u f a c t u r e m e d i c i n a l p r o d u c t s s o a s t o e n s u r e t h a t t h e y a r e f i t f o r t h e i r i n t e n d e d u s e , c o m p l y w i t h t h e r e q u i r e m e n t s o f t h e M a r k e t i n g A u t h o r i s a t i o n o r C l i n i c a l T r i a l A u t h o r i s a t i o n , a s a p p r o p r i a t e , a n d d o n o t p l a c e p a t i e n t s a t r i s k d u e t o i n a d e q u a t e s a f e t y, q u a l i t y o r e f f i c a c y. T h e a t t a i n m e n t o f t h i s q u a l i t y o b j e c t i v e i s t h e r e s p o n s i b i l i t y o f s e n i o r m a n a g e m e n t a n d r e q u i r e s t h e p a r t i c i p a t i o n a n d c o m m i t m e n t b y s t a f f i n m a n y d i f f e r e n t d e p a r t m e n t s a n d a t a l l l e v e l s w i t h i n t h e c o m p a n y, b y t h e c o m p a n y s s u p p l i e r s a n d b y i t s d i s t r i b u t o r s.

2 T o a c h i e v e t h i s q u a l i t y o b j e c t i v e r e l i a b l y t h e r e m u s t b e a c o m p r e h e n s i v e l y d e s i g n e d a n d c o r r e c t l y i m p l e m e n t e d P h a r m a c e u t i c a l Q u a l i t y S ys t e m i n c o r p o r a t i n g G o o d M a n u f a c t u r i n g P r a c t i c e a n d Q u a l i t y R i s k M a n a g e m e n t . I t s h o u l d b e f u l l y d o c u m e n t e d a n d i t s e f f e c t i v e n e s s m o n i t o r e d . A l l p a r t s o f t h e P h a r m a c e u t i c a l Q u a l i t y S ys t e m s h o u l d b e a d e q u a t e l y r e s o u r c e d w i t h c o m p e t e n t p e r s o n n e l , a n d s u i t a b l e a n d s u f f i c i e n t p r e m i s e s , e q u i p m e n t a n d f a c i l i t i e s.

3 T h e r e a r e a d d i t i o n a l l e g a l r e s p o n s i b i l i t i e s f o r t h e h o l d e r o f t h e M a n u f a c t u r i n g A u t h o r i s a t i o n a n d f o r t h e A u t h o r i s e d P e r s o n ( s ) . 1 2 3 4 5 1 2 3 4 5 T h e b a s i c c o n c e p t s o f Q u a l i t y M a n a g e m e n t , G o o d M a n u f a c t u r i n g P r a c t i c e ( G M P )

4 A n d Q u a l i t y R i s k M a n a g e m e n t a r e i n t e r - r e l a t e d . T h e y a r e d e s c r i b e d h e r e i n o r d e r t o e m p h a s i s e t h e i r r e l a t i o n s h i p s a n d t h e i r f u n d a m e n t a l i m p o r t a n c e t o t h e p r o d u c t i o n a n d c o n t r o l o f m e d i c i n a l p r o d u c t s . PHARMACEUTICAL QUALITY SYSTEM 1 National requirements require manufacturers to establish and implement an effective pharmaceutical quality assurance system. The term Pharmaceutical Quality System is used in this chapter in the interests of consistency with ICH Q10 terminology. For the purposes of this chapter these terms can be considered interchangeable.

5 1 . 1 Q u a l i t y M a n a g e m e n t i s a w i d e - r a n g i n g c o n c e p t , w h i c h c o v e r s a l l m a t t e r s , 1 . 1 2 w h i c h i n d i v i d u a l l y o r c o l l e c t i v e l y i n f l u e n c e t h e q u a l i t y o f a p r o d u c t . I t i s t h e s u m t o t a l o f t h e o r g a n i s e d a r r a n g e m e n t s m a d e w i t h t h e o b j e c t i v e o f e n s u r i n g t h a t m e d i c i n a l p r o d u c t s a r e o f t h e q u a l i t y r e q u i r e d f o r t h e i r i n t e n d e d u s e . Q u a l i t y M a n a g e m e n t t h e r e f o r e i n c o r p o r a t e s G o o d M a n u f a c t u r i n g P r a c t i c e.

6 1 . 2 G M P a p p l i e s t o t h e l i f e c yc l e s t a g e s f r o m t h e m a n u f a c t u r e o f i n v e s t i g a t i o n a l m e d i c i n a l p r o d u c t s , t e c h n o l o g y t r a n s f e r , c o m m e r c i a l m a n u f a c t u r i n g t h r o u g h t o p r o d u c t d i s c o n t i n u a t i o n . H o w e v e r t h e P h a r m a c e u t i c a l Q u a l i t y S ys t e m c a n e x t e n d t o t h e p h a r m a c e u t i c a l d e v e l o p m e n t l i f e c yc l e s t a g e a s d e s c r i b e d i n I C H Q 1 0 , w h i c h w h i l e o p t i o n a l , s h o u l d f a c i l i t a t e i n n o v a t i o n a n d c o n t i n u a l i m p r o v e m e n t a n d s t r e n g t h e n t h e l i n k b e t w e e n p h a r m a c e u t i c a l d e v e l o p m e n t a n d m a n u f a c t u r i n g a c t i v i t i e s.

7 1 . 2 The size and complexity of the company s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. T h e design of the system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level. 1 . 3 A Pharmaceutical Quality System appropriate for the manufacture of medicinal products should ensure that: 1.

8 4 ( i ) P r o d u c t r e a l i s a t i o n i s a c h i e v e d b y d e s i g n i n g , p l a n n i n g , i m p l e m e n t i n g , m a i n t a i n i n g a n d c o n t i n u o u s l y i m p r o v i n g a s ys t e m t h a t a l l o w s t h e c o n s i s t e n t d e l i v e r y o f p r o d u c t s w i t h a p p r o p r i a t e q u a l i t y a t t r i b u t e s ; ( i ) ( i i ) P r o d u c t a n d p r o c e s s k n o w l e d g e i s m a n a g e d t h r o u g h o u t a l l l i f e c yc l e s t a g e s ; ( i i ) ( i i i ) M e d i c i n a l p r o d u c t s a r e d e s i g n e d a n d d e v e l o p e d i n a w a y t h a t t a k e s a c c o u n t o f t h e r e q u i r e m e n t s o f G o o d M a n u f a c t u r i n g P r a c t i c e ; ( i i i ) ( i v ) P r o d u c t i o n a n d c o n t r o l o p e r a t i o n s a r e c l e a r l y s p e c i f i e d a n d G o o d M a n u f a c t u r i n g P r a c t i c e a d o p t e d ; ( i v ) 3 ( v ) M a n a g e r i a l r e s p o n s i b i l i t i e s a r e c l e a r l y s p e c i f i e d.

9 ( v ) ( v i ) A r r a n g e m e n t s a r e m a d e f o r t h e m a n u f a c t u r e , s u p p l y a n d u s e o f t h e c o r r e c t s t a r t i n g a n d p a c k a g i n g m a t e r i a l s , t h e s e l e c t i o n a n d m o n i t o r i n g o f s u p p l i e r s a n d f o r v e r i f yi n g t h a t e a c h d e l i v e r y i s f r o m t h e a p p r o v e d s u p p l y c h a i n ; ( v i ) ( v i i ) P r o c e s s e s a r e i n p l a c e t o a s s u r e t h e m a n a g e m e n t o f o u t s o u r c e d a c t i v i t i e s ; ( v i i ) ( v i i i ) A s t a t e o f c o n t r o l i s e s t a b l i s h e d a n d m a i n t a i n e d b y d e v e l o p i n g a n d u s i n g e f f e c t i v e m o n i t o r i n g a n d c o n t r o l s ys t e m s f o r p r o c e s s p e r f o r m a n c e a n d p r o d u c t q u a l i t y.

10 ( v i i i ) ( i x ) T h e r e s u l t s o f p r o d u c t a n d p r o c e s s e s m o n i t o r i n g a r e t a k e n i n t o a c c o u n t i n b a t c h r e l e a s e , i n t h e i n v e s t i g a t i o n o f d e v i a t i o n s , a n d , w i t h a v i e w t o t a k i n g p r e v e n t i v e a c t i o n t o a v o i d p o t e n t i a l d e v i a t i o n s o c c u r r i n g i n t h e f u t u r e ; ( i x ) ( x ) A l l n e c e s s a r y c o n t r o l s o n i n t e r m e d i a t e p r o d u c t s , a n d a n y o t h e r i n - p r o c e s s c o n t r o l s a n d v a l i d a t i o n s a r e c a r r i e d o u t ; ( x ) ( x i ) C o n t i n u a l i m p r o v e m e n t i s f a c i l i t a t e d t h r o u g h t h e i m p l e m e n t a t i o n o f q u a l i t y i m p r o v e m e n t s a p p r o p r i a t e t o t h e c u r r e n t l e v e l o f p r o c e s s a n d p r o d u c t k n o w l e d g e.