pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. Companies could benefit from talking to third party experts such as NSF to ensure that they are in compliance.

Diabetes 111

Diabetes Dosage Pharmaceutical Manufacturing Documentation 111

Pharmaceutical Technology

SEPTEMBER 14, 2022

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables.

Dosage 40

Dosage Pharmaceutical Manufacturing Documentation Pharmaceutical Companies 40

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintain documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

The keywords in any change control management process are compliance with regulatory requirements, impact assessment, change verification, and maintaining documentation. Why is change control management important in pharmaceuticals? Change control management is a critical and frequently used concept in pharmaceutical industry.

Documentation 52

Documentation Packaging Communication Customer Service 52

GMPSOP

SEPTEMBER 27, 2023

The practice of calling a piece of equipment clean just because it looks clean is not acceptable in the pharmaceutical manufacturing process. Additional documents included each month. – To conduct the validation studies in accordance with the protocols and to document the results of studies.

Method Validation 98

Method Validation Documentation Pharmaceutical Manufacturing Dosage 98

GMPSOP

MARCH 8, 2024

– Please make sure that proper documentation is maintained and corrective action is undertaken. The FDA subsequently published several guidance documents regarding this matter. Additional documents included each month. Additional documents included each month. Additional documents included each month.

Documentation 52

Documentation Dosage Pharmaceutical Manufacturing Packaging 52

GMPSOP

OCTOBER 28, 2023

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

Documentation 52

Documentation Method Validation Packaging Data Entry 52