Direct Links to important GMP Sterile & Aseptic Processing Guidelines

PIC/S Isolators used for Aseptic Processing and Sterility Testing (PI 014-3) Sept 2007

This Recommendation applies to isolators subjected to a sporicidal process used for aseptic processing and sterility testing.

more

FDA Program 7356.002A Sterile Drug Process Inspections

This program covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized.

more

WHO Good Manufacturing Practices for Sterile pharmaceutical products

GMP requirements of the WHO for the manufacture of Sterile pharmaceutical products

more

APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999

This document provides guidance for the manufacture and handling of sterile APIs.

more

WHO Figures to guideline ob GMPs for HVAC-Systems for non-sterile dosage forms

APPENDIX TO MAIN GUIDELINES

more

WHO Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms (Annex5, TRS 961)

These guideline focuses primarily on the design and good manufacturing practices (GMP) requirements for HVAC systems for facilities for the manufacture of solid dosage forms. Most of the system design principles for facilities manufacturing solid dosage forms also apply to other facilities such as those manufacturing liquids, creams and ointments. These guidelines do not cover requirements for manufacturing sites for the production of sterile pharmaceutical products. These guidelines are intended as a basic guide for use by GMP inspectors.

more

FDA Guidance for Industry: Sterility Requirement for aqueous-Based Products for Oral Inhalation - small Entity Compliance Guide

This guidance restates in plain language the legal requirements set forth in the current regulation requiring that all prescription and over-the counter (OTC) aqueous-based drug products for oral inhalation be manufactured sterile

more

FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)

This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for transfer sets (excluding sterile connecting devices) used in blood establishments.

more

FDA Guidance for Industry Use of Sterile Connecting Devices in Blood Bank Practices

This guidance describes recommended practices and procedures for use of Sterile Connecting Devices.

more

FDA Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices)

This guidance presents an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted for such devices and the approach FDA reviewers normally should take in reviewing premarket submissions for transfer sets (excluding sterile connecting devices) used in blood establishments.

more

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK