GMP Supplementary Guidelines For Pharmaceutical Excipient

WHO Good Manufacturing Practices: Supplementary Guidelines For The Manufacture Of Pharmaceutical Excipient

Annex 5

Click on the any titles below for complete guidelines

TABLE OF CONTENTS

1.  General Considerations

2.  Glossary

3.  Self-Inspection and Quality Audits

4.  Equipment

     4.1  Use of Equipment

     4.2  Cleaning Programme

            4.2.1  Detailed Cleaning Procedure

            4.2.2  Sampling Plan

            4.2.3  Analytical Methods/Cleaning Limits

5.  Materials

     5.1  General

     5.2  Starting Materials

     5.3  Rejected and Recovered Materials

     5.4  Returned and Excipients

     5.5  Storage Practices

6.  Documentation 

     6.1  General

     6.2  Specifications

     6.3  Batch Production Records

     6.4  Other Documents

7.  Good Practices in Production and Quality Control

     7.1  Change Control and Process Validation

     7.2  Good Practices in Production

            7.2.1  Prevention of Cross-Contamination 

            7.2.2  In-process Blending/Mixing

            7.2.3  Control of Microbial Contamination

            7.2.4  Water Systems/Water Quality

            7.2.5  Packaging Operations

            7.2.6  Delivery

     7.3  Good Practices in Quality Control

            7.3.1  General

            7.3.2  Control of Starting Materials

            7.3.3  In-process Testing

            7.3.4  Quality Records and Retention Samples

            7.3.5  Stability Studies

            7.3.6  Expiry/Re-evaluation Dating

            7.3.7  Calibration of Measuring and Test Equipment

GMP Supplementary Guidelines For Pharmaceutical Excipient