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Industry Issues: Contamination Control Strategy, Data Integrity, QbD

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

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