Certification, GMP and global Pharmacopeia compliance

Product and process documentation

All Nexcel^® primary films are manufactured to GMP standards in line with FDA CFR21 and comply with the needs of the US, European and Japanese pharmacopeias.

In addition, Sealed Air has a Drug Master File filed with the FDA which can be used by customers to support their own product validation dossier

A wide range of data sheets, compliance certificates and other documents can be supplied as part of the product approval process.

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Certification, GMP and global Pharmacopeia compliance

Product and process documentation

All Nexcel® primary films are manufactured to GMP standards in line with FDA CFR21 and comply with the needs of the US, European and Japanese pharmacopeias.

In addition, Sealed Air has a Drug Master File filed with the FDA which can be used by customers to support their own product validation dossier

A wide range of data sheets, compliance certificates and other documents can be supplied as part of the product approval process.

All Nexcel^® primary films are manufactured to GMP standards in line with FDA CFR21 and comply with the needs of the US, European and Japanese pharmacopeias.