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Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes.

The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.

Contact MPI at [email protected] 353 (0)1 846 47 42 to discuss your requirements with one of our experts.

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The Agency also plays a key role in coordinating and harmonising GMP activities at an EU level.

Pharma Lex Ireland (MPI) has a team of consultants, which includes a number of former EU regulators, and can provide support and advice.

were not always established /maintained /followed/ available to personnel in the areas where procedures were performed Scientifically sound laboratory controls – Laboratory controls do not include the establishment of scientifically sound and appropriate specifications /standards/ sampling plans/ test procedures designed to assure that components/drug product containers/closures/ in-process materials/ labelling/drug products conform to appropriate standards of identity, strength, quality and purity Concurrent documentation – Records are not concurrently maintained with the performance of each significant step in the collection/processing/compatibility testing/ storage/ distribution of each unit of blood and blood components so that all steps can be clearly traced Investigations of discrepancies, failures – There is a failure to thoroughly review any unexplained discrepancy/the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed.

Thorough investigations – Failure to perform a thorough investigation/make a record of the conclusions and follow-up of an unexplained discrepancy/a failure of a lot or unit to meet any of its specifications Absence of Written Procedures – There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess Person performing, test results, interpretation – Records fail to identify the person performing the work/ include dates of the various entries/ show test results/ include interpretation of the results/ show the expiration date assigned to specific products/ be as detailed as necessary, so as to provide a complete history of the work performed Data Integrity deficiencies Is data integrity ensured at your facility?

Importers are responsible to ensure that the third country manufacturer they are importing from comply with GMP.

Marketing authorisation applicants are responsible to ensure that the proposed manufacturing sites included in the marketing auhtorisation application comply with GMP.

GMP Non Compliance: Warning letters companies have received and the reasons behind it In cases of serious violations and of Good Manufacturing Practice (GMP) requirements, the Food and Drug Administration (FDA) issues a warning letters to the company in question outlining the violations.

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