약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 1.

Table. 1.

Change Summary of EU GMP Guideline Annex.1

Section General overview
Scope Includes additional areas (other than sterile products) where the general principles of the annex can be applied.
Principle General principles as applied to the manufacture of sterile products.
Pharmaceutical Quality System (PQS) Highlights the specific requirements of the PQS when applied to sterile products.
Premises General guidance regarding the specific needs for premises design and also guidance on the qualification of premises including the use of Barrier Technology.
Equipment General guidance on the design and operation of equipment.
Utilities Guidance with regards to the special requirements of utilities such as water, gas and vacuum.
Personnel Guidance on the requirements for specific training, knowledge and skills. Also gives guidance to the qualification of personnel.
Production and specific technologies Discusses the approaches to be taken with regards to aseptic and terminal sterilization processes. Discusses approaches to sterilization of products, equipment and packaging components. Also discusses different technologies such as lyophilization and Form-Fill-Seal where specific requirements apply.
Viable and non-viable environmental and process monitoring This section differs from guidance given in section 4 in that the guidance here applies to ongoing routine monitoring with regards to the design of systems and setting of action limits alert levels and reviewing trend data.
The section also gives guidance on the requirements of Aseptic Process Simulation (APS).
Quality control (QC) Gives guidance on some of the specific Quality Control requirements relating to sterile products.
Glossary Explanation of specific terminology.
Yakhak Hoeji 2021;65:432-40 https://doi.org/10.17480/psk.2021.65.6.432
© 2021 Yakhak Hoeji