PIC/S Guidance
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PIC/S PI 041-1 Draft Guidance: Good Practices for Data Management and Integrity, 11/18
November 2018, Draft PIC/S data management and integrity guidelines for manufacturers and distributors of APIs and medicinal products.
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Introduction), 1/17
Introduction to the January, 2017 version of the PIC/S GMP (good manufacturing practices) Guide. Explains the organization of Parts I and II and the Annexes
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PIC/S PE 009-13 Guide to Good Manufacturing Practices for Medicinal Products (Part I), 1/17
In January, 2017 this PIC/S GMP guide went into effect. It includes expectations for documentation and expectations for validation.
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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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PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15
Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.
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PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products, 6/14
In June, 2014, this PIC/S Guide went into effect to ensure high standards of quality assurance and integrity for distribution of medicinal product.
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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.
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PIC/S PI 030-1 Aide-Memoire: Inspection of Active Pharmaceutical Ingredients, 1/09
This 2009 inspector’s guide directs focus towards control room system validation & back-ups, material status control system validation & security.
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PIC/S PI 028-1 PIC/S Aide-Memoire: GMP Inspection Related to Packaging, 1/09
This 2009 inspector’s guide directs focus towards electronic devices to establish identity, electronic batch records, security and electronic signatures.
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PIC/S PI 011-3 PIC/S Guidance: Good Practices for Computerised Systems in Regulated “GXP” Environments, 9/07
PIC/S Guidance for validation, testing, life cycle, change control, electronic signatures, security, back-ups, and inspection of GxP computerized systems.
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PIC/S PE 005-3 GMP Guide for Blood Establishments, 9/07
September 2007 guidance for blood establishment inspections, including recommendations on system validation, security, backups, training, and change control.
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PIC/S PI 023-2 Aide-Memoire: Inspection of Pharmaceutical Quality Control Laboratories, 9/07
This PIC/S memory aid provides guidance to QC lab inspectors. It instructs inspectors to check LIMS validation, change control, training, access authorization, and security.
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