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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Any documentation, such as validation reports then helps with compliance and later regulatory submissions and requests.

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EU fines Teva and Cephalon €60.5m for ‘pay for delay’ scheme

pharmaphorum

Although Teva and Cephalon are now the same company, the case dates back to June 2005 when the firms were separate entities. The two companies agreed to settle the dispute but as part of the settlement Teva received a package of commercial side-deals and cash payments.

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Safe Handling of Hazardous Drugs

RX Note

The Hidden Truth Studies have shown that the antineoplastic residues can be found be on the external packaging of both oral and IV drugs. Change gloves every 30 minutes during compounding or immediately when damaged or contaminated, unless otherwise recommended by the manufacturer's documentation.

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Corrective and Preventive Action (CAPA) Procedure for GMP

GMPSOP

ISO 9000:2005 Sec. Additional documents included each month. In a packaging line, a printer was used to imprint manufacturing and expiry dates on a batch of empty cartons which will be used to fill tablet strips. Further to corrective action, the defective packaging (carton) lot was destroyed which was initially quarantined.

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

One area in which the problem can be tackled effectively is product packaging. With predictions that the global market for anticounterfeiting packaging is set to reach almost $250 billion by 2026, growth in authentication and anti-tamper devices such as holograms appear to have a healthy future.”

Packaging 111
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Regulating decentralised manufacturing in the UK – a legal perspective

European Pharmaceutical Review

In the EU, the EU pharmaceutical package of reform 5 includes a proposed new Directive, 6 which will replace the current Medicines Directive (2001/83/EC). Master file the manufacturing dossier in which the main regulatory documents are collected and to which all subordinate sites refer. One file per product. Internet] UK Government.