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Inspection Regulations

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Conditions for Acceptance of Foreign Inspection Reports
The purpose of this document is to provide guidance with respect to the type of information that the Health Products and Food Branch Inspectorate (HPFBI) will accept in order to assess the compliance of foreign sites with Good Manufacturing Practices (GMP). Health Canada

 2001-01-01   PDF PDF file (40 KB) 

Compliance and Enforcement Policy
The purpose of this document is to provide the staff of the Health Products and Food Branch Inspectorate (Inspectorate) with guiding principles for the fair, consistent, and uniform application and enforcement of the Acts and Regulations under its mandate: the Food and Drugs Act1 (FDA) and the Controlled Drugs and Substances Act2 (CDSA) and their associated Regulations3 (Acts and Regulations). Health Canada

 2001-01-01   PDF PDF file (55 KB) 

Guide to Inspections of Bulk Pharmaceutical Chemicals
This document is intended to aid agency personnel in determining whether the methods used in, and the facilities and manufacturing controls used for, the production of Bulk Pharmaceutical Chemicals (BPCs) are adequate to assure that they have the quality and purity which they purport or are represented to possess. FDA

 1994-01-01   PDF PDF file (100 KB) 

Biotechnology Inspections Guide
This Guide addresses some of the basic problems identified during inspections of manufacturers of biotechnically- derived substances. Production systems may include animals, cell clones (e.g. hybridomas), mammalian and insect cell cultures, yeast, and bacteria or combinations of these systems. FDA

 1991-01-01   PDF PDF file (187 KB) 

Guide to Inspections of Foreign Medical Device Manufacturers
This guide was prepared to address concerns about consistency and uniformity of inspection between the domestic and foreign inspection programs. The guide sets forth clear instructions regarding the approach to the foreign inspection. FDA

    PDF PDF file (26 KB) 

Guide to Inspections of Dosage Form Drug Manufacturer's - CGMPR's
This document is intended to be a general guide to inspections of drug manufacturers to determine their compliance with the drug CGMPR's. FDA

    PDF PDF file (70 KB) 

Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
Guide to the inspection of the microbiology analytical process. FDA

    PDF PDF file (33 KB) 

Guide to Inspections of Foreign Pharmaceutical Manufacturers
The guidance provided in this document is intended to establish greater consistency and uniformity in inspectional activities at both domestic and foreign drug manufacturers. FDA

    PDF PDF file (54 KB) 

Guide to Inspections of Pharmaceutical Quality Control Laboratories
This inspection guide supplements other inspectional information contained in other agency inspectional guidance documents. FDA

    PDF PDF file (58 KB) 

Guide to Inspections of Sterile Drug Substance Manufacturers
The Guide provides directions for the inspection of the manufacture of the sterile bulk powders. FDA

    PDF PDF file (36 KB) 

Guide to Inspections Validations of Cleaning Processes
This guide is designed to establish inspection consistency and uniformity by discussing practices that have been found acceptable (or unacceptable). This guide is intended to cover equipment cleaning for chemical residues only. FDA

    PDF PDF file (30 KB) 

Guide to Inspections of Viral Clearance Processes
This guidance is designed for the use of FDA field investigators conducting inspection of plasma derivative manufacturers previously inspected by the Center for Biologics Evaluation and Review (CBER).

    PDF PDF file (60 KB) 

Guide to Inspections of High Purity Water Systems
This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. FDA

    PDF PDF file (68 KB) 

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