Express Pharma

JUNE 5, 2024

Although less commonly discussed, pharmaceutical compounds can also become airborne. This can occur through the evaporation of volatile substances or the incineration of pharmaceutical waste, potentially affecting air quality and contributing to broader environmental pollution.

Pharmaceutical Manufacturing 95

Pharmaceutical Manufacturing Packaging Documentation Compounding 95

GMPSOP

MAY 31, 2024

A validation master plan (VMP) is a strategic document that identifies the elements to validate, the approach to each element, organizational responsibilities, and a strategy for maintaining validation documentation. – General guidance for validation document format. Additional documents included each month.

Documentation 59

Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

Quality Matters

SEPTEMBER 15, 2023

FDA Guidance on Testing High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol (Disclaimer: The article below includes a discussion of key points of the guidance document. It is not the guidance document, nor it is an alternative to the guidance document. The guidance document is available here: [link].)

Documentation 52

Documentation Compounding Pharmaceutical Manufacturing 52

GMPSOP

FEBRUARY 28, 2024

Regulatory requirements for cleaning and sanitation in pharmaceuticals For more than a few decades, it has been an essential GMP requirement that all cleaning and sanitation steps in a pharmaceutical plant be documented accurately and validated to prove they work. Additional documents included each month.

Documentation 98

Documentation Packaging Pharmaceutical Manufacturing Compounding 98

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

GMPSOP

MAY 17, 2024

Regulatory requirements for GMP cleaning and sanitation in pharmaceuticals For more than a few decades, it has been an essential GMP requirement that all cleaning and sanitation steps in a pharmaceutical plant be documented accurately and validated to prove they work. Additional documents included each month.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing Compounding 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