Environmental Protection Agency

Selected Information Management (IM) and Information Technology (IT) Programs and IT Policies.

Good Automated Laboratory Practices (GALP)

Principles and Guidance to Regulations For Ensuring Data Integrity In Automated Laboratory Operations with Implementation Guidance

GAMP Online

The Site for Good Automated Manufacturing Practice. This includes the GAMP guide "Good Automated Manufacturing Practice for Validation of Automated Systems in Pharmaceutical Manufacture" - for use by suppliers to the pharmaceutical manufacturing industry when developing automated systems.

Food and Drug Administration

Please click this link for the 21 CFR Part 11 Regulations and guidelines - Title 21 Code of Federal Regulations, Electronic Records; Electronic Signatures.

Click here for FDA's Guide to Inspections of Quality Systems .

The FDA Predicate Rules

Food

21CFR106
Infant Formula Quality Control Procedures

21CFR107
Infant Formula

21CFR110
Current Good Manufacturing Practice in Manufacturing, Packing and Holding Human Food

21CFR113
Thermally Processed Low Acid Foods Packaged in Hermetically Sealed Containers

21CFR114
Acidified Foods

21CFR123
Food for Human Consumption : Fish and Fishery Products

21CFR129
Processing and bottling of Bottled Drinking Water

Links to the GxP Predicate Rules

GLP

21CFR58 - Good Laboratory Practice for Nonclinical Laboratory Studies

GMP

21CFR210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; Gene

21CFR211 - Current Good Manufacturing Practice For Finished Pharmaceuticals

GCP

21CFR50 - Protection of Human Subjects

21CFR54 - Financial Disclosure by Clinical Investigators

New Drugs

21CFR310 - New Drugs

21CFR312 - Investigational New Drug Application

21CFR314 - Applications for FDA Approval to Market a New Drug

Medical Devices

21CFR803 - Medical Device Reporting

21CFR806 - Medical devices – Reports of Corrections and Removals

21CFR808 - Exemptions from Federal Preemption of State and Local Medical Device Requirements

21CFR814 - Premarket Notification

21CFR820 - Quality System Regulation

More FDA Regulations

21CFR1 - General Enforcement Regultation

21CFR11 - Electronic Records/Electronic Signatures

21CFR56 - Institutional Review Boards – Table of contents

Food Standards Agency Regulations (UK)

The Food Standards Agency is an independent food safety watchdog set up by an Act of Parliament in 2000 to protect the public's health and consumer interests in relation to food.

ISO Standards

ISO/IEC 17025:1999

Contains the general requirements to show that testing and calibration laboratories have to meet to demonstrate that they are competent and operate a quality system, are technically competent, and are able to generate technically valid results.

ISO9001:2002
Autoscribe Ltd. is certified to ISO9001:2000 and is regularly audited both internally and externally to this standard. 

UKAS

UKAS accredits laboratories to provide traceable calibrations and measurements. The UK government recognises UKAS as the national accreditation body.

Autoscribe has been accredited to ISO9000 since 1997 across product development and all departments of its LIMS, Scientific and Business Software solutions business.

ISO 9000 is the generic name given to the family of standards around which a QMS can be implemented. These consist of:

• ISO 9000: 2000 Quality management systems - Fundamentals and vocabulary
• ISO 9001: 2000 Quality management system - Requirements
• ISO 9004: 2000 Quality management system - Guidelines for performance improvement.

MHRA – Medicines and Healthcare products Regulatory Agency

The MHRA combines the responsibilities of the former medicines control and medical devices agencies and is an executive agency of the Department of Health. MHRA enhances and safeguards the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.