Direct Links to important GMP Sterile & Aseptic Processing Guidelines

FDA Guidance for Industry: SUPAC: Manufacturing Equipment Addendum

This draft guidance combines and supersedes the following scale-up and post-approval changes (SUPAC) guidances for industry: (1) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms, Manufacturing Equipment Addendum, and (2) SUPAC-SS Nonsterile Semisolid Dosage Forms, Manufacturing Equipment Addendum. It removes the lists of manufacturing equipment that were in both guidances and clarifies the types of processes being referenced.

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Eudralex Volume 3 Sterilisation of the medicinal product, active substance, excipient and primary container

This guideline provides guidance on the documentation expected for sterile products in the quality dossier for a marketing authorisation application or a variation application for a medicinal product, (called quality dossier throughout the guideline), and the selection of appropriate methods of sterilisation for sterile products. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur) is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with an additional terminal microbial reduction process), could be accepted as an alternative to a reference terminal sterilisation process.

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EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)

Annex 1 Consultation Document December 2017

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Certificates of suitability for sterile active substances

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Clarification on the acceptability of CEP applications for sterile grade material

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WHO Guidelines on heating, ventilation and air-conditioning systems for non-sterile pharmaceutical products

Supplement to HVAC Guide from 2011

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GMP Conferences by Topics

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