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Beschikbare richtlijnen

19 resultaten

Rapid alert notification of a quality defect / recall

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice).

GDP EMA

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Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Question and answers on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Aide-Memoire for GDP Inspections

Imported from European Commission — EudraLex (https://health.ec.europa.eu/medicinal-products/falsified-medicines_en).

GDP EC

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Note for guidance on manufacture of the finished dosage form - First version

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Guideline on declaration of storage conditions

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers).

GDP EMA

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Follow-up and non-urgent information for quality defects

Imported from European Medicines Agency (https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice).

GDP EMA

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Richtlijnen Kennisbank

Beschikbare richtlijnen

Rapid alert notification of a quality defect / recall

Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country

Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final

Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...

Question and answers on the use of X-ray sterilisation processes for Single Use Systems (SUS) used in pharmaceutical manufacturing

Aide-Memoire for GDP Inspections

Note for guidance on manufacture of the finished dosage form - First version

Guideline on declaration of storage conditions

Follow-up and non-urgent information for quality defects

Ontvang richtlijnupdates in uw mailbox