Pharma Specialists

Vendor Assessment

New Vendor Approval Process in Pharmaceutical Industry

Vendor approval activities are a routine work for a pharmaceutic…

April 27, 2023

Automation

Risk-Based Approach for Computer Systems Validation

GxP regulated companies are expected to adopt a risk-based appro…

April 26, 2023

Regulatory Affairs

Regulatory Dossier and Its Contents

A regulatory dossier is a package of documents, which may includ…

April 23, 2023

WHO

WHO Guidance on Testing of Suspect Falsified Medicines

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

April 20, 2023

Dissolution

The Effect of Storage Conditions on Dissolution

Being a surrogate marker for bioequivalence, any change in disso…

April 19, 2023

Pharma Suppliers

Pharma Suppliers in Netherlands

A List of Pharma Suppliers in Netherlands ACE PHARMACEUTICALS AP…

April 16, 2023

Calibration

Calibration | As per EU and USFDA GMP Requirements

The pharmaceutical sector is governed by regulatory norms to ens…

April 12, 2023

Tablets

Quality Attributes of Tablets Labeled as Having a Functional Score

It’s fairly common practice to split tablets along the functiona…

April 10, 2023

WHO

Good Manufacturing Practices for Medicinal Gases | WHO Guidance

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

April 09, 2023

Pharma Manufacturing

Contamination and Cross Contamination in Pharmaceutical Industry

Contamination or Cross-contamination could be an outcome of acci…

April 08, 2023

SCM

Pharmaceutical Supply Chain | A Complex and Multifaceted Task

The pharmaceutical supply chain is a complex network of manufact…

April 06, 2023

Qualification

Equipment Qualification and Equipment Mapping in Labs

In a laboratory setting, temperature-controlled units, such as f…

April 05, 2023

Pharma Manufacturing

Pharmaceutical Grade Stainless Steel

Pharmaceutical companies must have pharmaceutical-grade stainles…

April 02, 2023

Aseptic Process

Risk Management for Aseptic Processes

Sterile drug products differ from other products in that they ar…

April 02, 2023

ICH

Quality Risk Management | ICH Q9 (R1)

ICH Q9 guideline describes systematic processes for the assessme…

April 01, 2023