Pharma Specialists

FDA

Relationship Between 21 CFR 820 and ISO 13485

1. Scope: 21 CFR 820: This regulation, also known as the Quality…

October 30, 2023

Calibration

Importance of Calibration in the Pharmaceutical and Life Science Industries

Below are the points that came to mind when I thought about the …

October 29, 2023

ARD

Why Should We Establish the Stability of Mobiles Phase?

It is a study of the time interval within which the mobile phase…

October 27, 2023

Sterilization

Why Validate Your Sterilization Process?

Sterilization is a vital step in ensuring the safety, efficacy, …

October 26, 2023

QMS

Why An Integrated Robust QMS is Important?

In the dynamic world of pharmaceutical manufacturing, the integr…

October 25, 2023

Stress Study

Purpose of Forced Degradation Study

“Stress testing of the drug substance can help identify the like…

October 24, 2023

FDA

Quality Considerations for Topical Ophthalmic Drug Products | FDA Guidance for Industry

This guidance discusses certain quality considerations for ophth…

October 23, 2023

Clinical Trials

Phases of Clinical Research

Each phase of clinical research has its own unique goals and cha…

October 21, 2023

Chromatography

How to Condition the GC Column?

Conditioning involves establishing a flow of carrier gas through…

October 18, 2023

Cleaning Validation

Main Considerations for MACO Calculation in Cleaning Validation

When it comes to ensuring the safety and quality of pharmaceutic…

October 16, 2023

ARD

Which Sovent is Better for Reverse Phase HPLC?

Acetonitrile (AcN) or methanol (MeOH)? This argument has been ar…

October 15, 2023

HPLC

10 Golden Tips for HPLC Column Regeneration

1. Flush the column with a suitable solvent After each use, flus…

October 14, 2023

VS

Difference Between LOD and LOQ

LOD (Limit of Detection) and LOQ (Limit of Quantification) are t…

October 13, 2023

QbD

Difference Between QbD & AQbD

Let's discuss on two commonly used terms in the pharmaceutic…

October 13, 2023

Dissolution

Coning in Dissolution Vessels

What is the coning problem in dissolution testing? and what ar…

October 10, 2023

Health and Safety

Why Do We Need to Wear a Lab Coat while Working in a Laboratory?

A laboratory coat, also known as a lab coat or a lab Apron is a …

October 09, 2023

Pharma Manufacturing

Good Design Practice of Pharmaceutical Facilities and Utilities

Are you involved in the design and construction of pharmaceutica…

October 09, 2023

Pharma Suppliers

Supplier Evaluation in Pharmaceutical Industry

According to Hald and Ellegaard (2011), supplier evaluation is &…

October 03, 2023