Pharma Specialists

WHO

WHO Guidance on Testing of Suspect Falsified Medicines

Based on Annex 5, WHO guidance Suspect medicines can be divided …

April 20, 2023

WHO

Good Manufacturing Practices for Medicinal Gases | WHO Guidance

This guideline focuses on the production, control, storage and…

April 09, 2023

Validation

Good Manufacturing Practices : WHO Guidelines on Validation

The need for revision of the published World Health Organization…

October 31, 2022

WHO

List of WHO Guidelines for Pharmaceutical Industry

WHO has formulated international regulatory standards, which inc…

October 13, 2022

Pharma Guidelines

Pharmaceutical Product Sampling | WHO Guideline

WHO guidelines for sampling of pharmaceutical products and relat…

May 27, 2022

Pharma Guidelines

WHO Guideline on Technology Transfer in Pharmaceutical Manufacturing

Technology transfer is the movement of data, designs, inventions…

April 03, 2022

GMP

GMP Facility Design | GMP Golden Rules

General GMP facilities must be designed with the following minim…

March 09, 2022

Audit

GMP Audit Checklist for Pharmaceutical | WHO Guideline (Part-3)

Sterile Processing Are the aseptic manufacturing areas and ope…

February 24, 2022

Audit

GMP Audit Checklist for Pharmaceutical | WHO Guideline (Part-2)

The WHO GMP checklist for facilities and support system is given…

February 22, 2022

Audit

GMP Audit Checklist for Pharmaceutical | WHO Guideline (Part-1)

As per WHO recent guideline for GMP audit following information …

February 21, 2022

Bioequivalence Study

USFDA/EMEA/CANADA/Japan/WHO guidelines on BioEquivalence (Part-3)

Study Population Criteria for BE study population: Min. of 12 su…

October 09, 2021