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.

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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.

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WHO Good Manufacturing Practices for Sterile pharmaceutical products

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

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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.

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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

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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.

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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.

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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.

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FDA COMPLIANCE POLICY GUIDE Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16) Page 5

Compliance Policy Guides explain the FDA policy on regulatory issues related to FDA laws and regulations. They also advise the field inspection staff about the FDA-standards to be applied when determining industry compliance.

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FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

This guidance document provides recommendations to manufacturers for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices.

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