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GMP Case Study: Lessons from FDA 483s & Warning Letters

 


WHO GMP

   

2014, TRS 986, Annex 2,

Good Manufacturing Practice for Pharmaceutical Products: main principles

 

Introduction

 

Glossary

1

Pharmaceutical quality system

2

Good manufacturing practices for pharmaceutical products

3

Sanitation and hygiene

4

Qualification and validation

5

Complaints

6

Product recalls

7

Contract production, analysis and other activities

8

Self-inspection, quality audits and supplier's audits and approval

9

Personnel

10

Training

11

Personal hygiene

12

Premises

13

Equipment

14

Materials

15

Documentation

16

Good practices in production

17

Good practices in quality control

 

References

   
 
   
 

 

 

 


 

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