Document Library
Showing 17–32 of 179 results
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part II), 1/17
This January, 2017 PIC/S GMP guide contains recommendations for computerized systems, electronic documents, validation, and change control.
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Annexes), 1/17
In January, 2017, this PIC/S GMP Guide went into effect. The annexes provide additional information applicable to both finished medicinal products and active substances (APIs).
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FDA Guidance: Postmarket Management of Cybersecurity in Medical Devices, 12/16
This 2016 FDA Guidance is intended to the medical device industry of agency recommendations for managing postmarket cybersecurity vulnerabilities.
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FDA Guidance: Use of Electronic Informed Consent Questions and Answers, 12/16
This December 2016 guidance provides information regarding implementation of FDA-compliant electronic Informed Consent technologies and processes.
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FDA Presentation: General Wellness Guidance: Policy for Low Risk Devices, 9/16
September 2016 FDA CDRH presentation to provide clarity and examples of low risk medical devices for general wellness.
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Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 9/16
2016 FDA adoption of the 2000 ICH GMP Guide for Active Pharmaceutical Ingredient (API) Manufacturers. Topics include system validation, audit trails, security, back-ups.
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EMA Data Integrity for GMP and GDP Q&A, 8/16
August, 2106, EMA publication answering 23 questions related to Data Integrity. Includes data risk assessment, security, data review, and supplier controls.
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FDA Guidance: General Wellness: Policy for Low Risk Devices, 7/16
This July 2016 FDA Guidance is intended to provide clarity on the compliance polity for low risk products that promote a healthy lifestyle.
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WHO Draft: Global Model Regulatory Framework for Medical Devices including IVDs, 7/16
This 2016 draft document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices.
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FDA Draft Guidance: Dissemination of Patient-Specific Information from Devices, 6/16
June 2016 Draft Guidance intended to clarify that manufacturers may share patient-specific information from medical devices with patients.
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WHO Annex 5 Guidance on Good Data and Record Management Practices, 2016
This 2016 WHO Guidance outlines expectations for achieving data and record integrity, reliability, access-ability, and protection.
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OECD The Application of GLP Principles to Computerised Systems, 4/16
2016 OECD publication of standards for laboratory computer systems used in clinical studies destined for regulatory submissions.
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FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, 1/16
The 2016 FDA Guidance on Design Considerations and Recommendations for Interoperable Medical Devices promotes safe, effective data exchange between devices.
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FDA Draft Guidance: Manufacturing Site Change Supplements, 10/15
This 2015 DRAFT guidance is meant to help firms manage the timeframes for changes in manufacturing sites, processes, methods, procedures, qualifications, & validations.
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Eudralex V4 Annex 16: Certification by a Qualified Person and Batch Release, 10/15
EudraLex Volume 4, Annex 16 specifically allows for the use of validated computerized systems as safeguards to ensure that uncertified batches are not sold.
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FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics, 07/15
FDA recommendations on analytical procedures and methods validation to support the identity, strength, quality, purity, and potency of drug substances and drug products.
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