Policy Guide CPG

First FDA Compliance Policy Guide (CPG) on computer systems — Computerized Prescription Record Keeping by Pharmacies... 

The FDA has published Compliance Policy Guide (CPG) 7132a. 15 dealing with process control application software source code issues. This guide establishes such source codes as one of the most important software validation documents. The guide specifies that drug manufacturers must ... 

Compliance Policy Guide 7132c.08. Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. FDA. http //www.fda.gov/ora/compliance ref/cpg/ cpgdrg/cpg490-100. html. 

FDA compliance policy guide section 130.000, FDA access to results of quality assurance program audits and inspections (CPG 7151.02), available http //www.fda.gov/ora/ compliance ref/cpg/cpggenl/cpgl30-300.html, accessed Dec. 5, 2006. 

FDA Compliance Policy Guides for Computerized Drug Processing. CGMP Applicability to Hardware and Software (CPG 7I32a.II) Vendor Responsibility (CPG 7I32a.I2) Source Code for Process Control Application Programs (CPG... 

Compliance Program 7151.02. FDA Access to Results of Quality Assurance Program Audits and Inspections, 1996. [Same as Compliance Policy guide 130.300.] http //www.fda.gov/ ora/compliance ref/cpg/cpggenl/cpg 130-300. html. 

Computerised Systems Used in Clinical Trials. FDA, 1999 http // www.fda.gov/ora/compliance ref/bimo/ffinalcct.htm Enforcement Policy Electronic Records Electronic Signatures— Compliance Policy Guide Guidance for FDA Personnel, FDA, 1999 http //www.fda.gov/ora/compliance ref/partll/FRs/np-dates/cpg-esig-enf-noa.htm... 

CPG (1991) Compliance Policy Guide Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities. CPG 7150.09, September. 

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