Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)
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Continuous Improvement – An integral part of the Pharmaceutical Quality System (PQS)

ByTina

‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…

Technical writing is a science, not an art
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Technical writing is a science, not an art

ByEleanor

Technical writing, in the context of the therapeutic goods industry, applies to those documents which instruct, define or report on regulated manufacturing activities; that is Standard Operating Procedures, forms, validation reports, and Design History Files, to name so very few and which are also referred to as “controlled documents”. So that these documents can be…

EudraLex Volume 4: EU Annex 21 GMP guidelines
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EudraLex Volume 4: EU Annex 21 GMP guidelines

ByConnie

EudraLex, Volume 4 – Good Manufacturing Guidelines European Union: EU GMP Guide Updates – EU Annex 21 (News) Manufacturers/Importers and Sponsors who import medicinal products into the EU/EEA must now comply with EU Annex 21 GMP requirements. Background to EU Annex 21 GMP guidelines for importation of medicinal products  EU Annex 21 was first published…

Supplier Qualification – Ensuring High Quality Suppliers
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Supplier Qualification – Ensuring High Quality Suppliers

ByMeghan

To comply with the requirements of GMP, manufacturers must ensure that any material or service providers that they use are able to meet strict quality standards. This is due to the potential impact of materials or services on the quality of a final therapeutic product. Achieving this standard requires that a number of procedures are…

E-Signatures on Documents in a GxP Environment – 7 Misconceptions
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E-Signatures on Documents in a GxP Environment – 7 Misconceptions

ByPharmOut

Electronic signatures (E-signatures) are becoming more and more commonly used in today’s world. Before electronic signatures were recognized and accepted legally, documents had to be manually signed by each of the signatories, stored and filed in squeaky compactors (compactus to some) held within a rather dark records room. Obviously, this process is very time consuming…