Document Library
Showing 49–64 of 179 results
-
PIC/S PE 010-4 Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments, 03/14
March, 2014 PIC/S guide for inspectors to use during audits of healthcare establishments that prepare medicinal products for direct supply to patients.
$0.00 Add to cart -
WHO Annex 2 Good Manufacturing Practices for Pharmaceutical Products, 1/14
2014 WHO Committee on Specifications for Pharmaceutical Preparations update to Annex 2, Good Manufacturing Practices for Pharmaceutical Products: Main Principles.
$0.00 Add to cart -
EMA Reflection Paper on Risk Based Quality Management in Clinical Trials, 11/13
This 2013 EMA Reflection Paper supports GCP principles by recommending a systematic, risk-based approach to quality management of clinical trials.
$0.00 Add to cart -
EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use 2013 v2, 11/13
In November, 2013 the EU Commission published Guidelines on Good Distribution Practice of Medicinal Products for Human Use. This replaces the March ’13 GDP directive.
$0.00 Add to cart -
FDA Guidance: Investigational Device Exemptions for Early Feasibility Medical Device Studies, 10/13
2013 FDA guidance to industry, clinicians, and innovators, regarding Investigational Device Exemptions (IDE) applications for early feasibility studies of high risk devices
$0.00 Add to cart -
FDA Guidance: Electronic Source Data in Clinical Investigations, 9/13
In September, 2013, the FDA issued this guidance to recommend practices to help ensure the reliability, quality, integrity, and traceability of electronic source data.
$0.00 Add to cart -
FDA Draft Guidance: Manufacturing Arrangements for Drugs – Quality Agreements, 5/13
This May 2013 FDA draft guidance make recommendations on the contents of contract manufacturing Quality Agreements and delineation of responsibilities for companies.
$0.00 Add to cart -
FDA Guidance: Blood Establishment Computer System Validation in the User’s Facility, 4/13
In April, 2013, the FDA published this guidance to assist blood establishments in developing computer system validation programs consistent with recognized principles.
$0.00 Add to cart -
Chinese Good Supply Practice for Pharmaceutical Products, 1/13
The 2013 Good Supply Practice for Pharmaceutical Products, includes the Chinese Ministry of Health’s requirements for use of computerized systems within the supply chain.
$0.00 Add to cart -
EMA Reflection Paper on GCP for Trial Master Files, paper or electronic (draft), 12/12
The EMA drafted this reflection paper to set the requirements for Trial Master Files (TMF) to facilitate trial management, GCP compliance, and inspections.
$0.00 Add to cart -
FDA Guidance: Clinical Performance Assessment, Considerations for Computer-Assisted Detection Devices Applied to Radiology Image, 7/12
This July 2012 US FDA guidance provides recommendations regarding clinical performance assessment of computer assisted detection (CADe) devices.
$0.00 Add to cart -
FDA 21 CFR 1271: Human Cells, Tissues, and Cellular and Tissue-based Products, 4/12
This CFR part creates a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s).
$0.00 Add to cart -
FDA 21 CFR 880: General Hospital and Personal Use Devices
21 CFR 880, General Hospital and Personal Use Devices, defines the FDA’s classification of commercially distributed hospital and personal use devices.
$0.00 Add to cart -
FDA 21 CFR 820: Quality System Regulation
21 CFR 820, the Quality System Regulation, sets forth the current good manufacturing practice (cGMP) requirements for finished devices intended for human use.
$0.00 Add to cart -
FDA 21 CFR 812: Investigational Device Exemptions
21 CFR 812 provides requirements for conducting of clinical investigations of medical devices.
$0.00 Add to cart -
FDA 21 CFR 606: cGMP for Blood and Blood Components
21 CFR 606 specifies current Good Manufacturing Practices for blood and blood products.
$0.00 Add to cart
