| |
Guideline
and Standards |
|
Description |
| |
Good Manufacturing Practices Guidelines |
|
Designed to facilitate compliance by the regulated industry
and enhance consistency in the application of the regulatory
requirements. This document is written with a view to
harmonize
with GMP standards from other countries and those of the
World Health Organization (WHO), the Pharmaceutical
Inspection Cooperation/ Scheme (PIC/S) and the International
Conference of Harmonization (ICH). This guideline reflects
results of the regulatory revisions due to the
implementation of the Mutual Recognition Agreements (MRA)
Framework. The MRA established mutual recognition of GMP
compliance certification and assessment methods by
regulatory authorities of countries designated as
equivalent. |
| |
|
|
|
| |
Cleaning Validation Guidelines
|
|
This document addresses special considerations and issues
pertaining to validation of cleaning procedures for
equipment used in the manufacture of pharmaceutical
products, radiopharmaceuticals, and biological drugs. |
| |
|
|
|
| |
|
|
|
