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  • Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now
    Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

    The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

  • Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations
    Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

    Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. In order to prove the requirements are met, qualification protocols have to be written and followed.

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
    How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

More From Pharma Contributing Editors

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More From Pharmaceutical Online Videos

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Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. In order to prove the requirements are met, qualification protocols have to be written and followed.

How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

Regulators, Standards Groups Address Emerging Tech In Biopharma Regulators, Standards Groups Address Emerging Tech In Biopharma

Manufacturers, suppliers, and regulators have recognized that introducing new technologies also introduces a degree of unfamiliarity and uncertainty.

More From Pharma Contributing Editors

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TITLE SUMMARY DISPLAY

  • Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

    The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

  • Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

    Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. In order to prove the requirements are met, qualification protocols have to be written and followed.

  • How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

    The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now Verification Of Serialized Drug Product — 60 Million Reasons Why Manufacturers Need To Act Now

The Drug Supply Chain Security Act (DSCSA) will soon deliver another big impact to both pharmaceutical manufacturers/marketing authorization holders (MAHs) and distributors, with requirements for serialized product verification to comply with the next phase of requirements coming into effect Nov. 27, 2019.

Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations Writing Compliant IQ/OQ/PQ Protocols — Meeting FDA Expectations

Writing effective IQ/OQ/PQ protocols is a must for following the regulations required by the FDA for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. In order to prove the requirements are met, qualification protocols have to be written and followed.

How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often

The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. The agency also introduced a multiyear resource planning process that will enable it to better use resources and plan frequencies of product sampling as well as inspections.

More From Pharma Contributing Editors